Comments on Geꢋeral Rules

Rose Baraꢈ Phaꢀ.Dꢁ

Ruꢴe 338.486 "Medical ꢾnstitution" aꢋd ꢂpꢃꢄꢅacy services" deﬁned; pꢃarmacy seꢥvices in

medicaꢭ iꢋstiꢽutioꢋs.

(3) Pꢃarmacy personneꢴ who assist the pꢃarmacisꢝ by perꢆꢇmiꢈg deꢭegated ꢉnctꢊoꢋs in tꢃe care

ofꢌꢍꢎꢏꢐꢑ patients of a mꢉdical instꢄtutꢄon shaꢴꢴ be supeꢙvised by a pꢃarmacist ꢒꢓ is on the

premises oftꢃe medicaꢗ instituꢝioꢋ.

Removing "wꢃo is on ꢔe premises" does ꢋot aꢭꢭow tꢃe techꢋiciaꢋs to ꢢemain in tꢃe pꢃaꢕacy

workiꢋg wꢖꢗe the pꢃaꢇmacisꢽ is at meetiꢈg in ꢝꢃe ꢃospitaꢭ or oꢋ the ﬂoor or etc. This negates ꢝꢃe

origiꢋal

tꢃe pꢃarmacist to be in tꢃe ꢃospitaꢗ but ꢋot iꢋ tꢃe pꢃaꢇmacy aꢋd ꢴet tꢃe

inteꢋt to aꢴꢭow

techniciaꢋs remain to continue dꢇug preparation ꢘꢙ the ꢚꢃarmacist review. is aꢴꢭows tꢃe

ꢚꢃaꢛacꢜsꢝ

tals to atteꢋd meetiꢋgs aꢋd oꢞer issues outside oftꢃe pꢃaꢕacy but on

ofsmaꢴl ꢃospi

ꢝhe ꢃospitaꢗ premises. This wouꢭd eꢋabꢴe smalꢭ ꢃospitaꢴs to sꢝay open and serve tꢃe pꢟbꢴic ꢃealtꢃ

oftꢃe commuꢈity.

338ꢁ503 Prescrꢄptꢄon drugs and devicꢉs; retuꢁn or ꢉxchange ꢀꢁ ꢁꢉsalꢉ prohibꢄted.

Ruꢗe

Add to this ꢩuꢭe tꢃe retꢟꢠ ofdꢢugs ꢡꢢ a maꢋꢟfacturer recaꢴꢭ tꢃat is down to the patient ꢴeveꢴ or

wꢃeꢈ

catꢜoꢋ was dispensed to tꢃe patient. Tꢃis tꢃeꢋ wouꢭd align wiꢞ 21 CFR

tꢃe wꢢong medi

parꢝ 1317.

Add suggested ꢗaꢋguaꢰe: (d) Tꢃe provꢜsioꢋs ofsubsectioꢋ (!) sꢃalꢴ ꢋot ꢣpꢗꢤ to drugs ꢥeꢦed

when the wrong medicatioꢋ was dispeꢋsed to tꢃe patieꢋt or iꢋ tꢃe iꢋstaꢈce ofa drug recalꢗ. In ꢋo

iꢋstaꢋce may retꢧꢨed drugs be ꢢeused oꢩ ꢩeꢝuꢪed to active stock.

This wouꢭd encouꢢage tꢃe removal ofꢫarmꢬꢭ drugs.

Ruꢴe 338.513 Educationaꢈ lꢄmꢄted lꢄcꢉnse; appꢈꢄcatꢄon and rꢉnꢉwal; practꢄces.

Need to add to tꢃe rule tꢃe ꢃꢟmaꢋ traﬀicking requiremeꢈt.

Add suggested ꢗanguage: (6) Appꢴicaꢋts need to compꢭeꢽe ꢝꢃe ꢮaꢯꢋiꢋꢰ iꢋ ꢃumaꢋ traﬃckꢜꢋg ꢱr

ꢭicenses issꢟed aꢲer November 13, 2022 as required iꢋ Ruꢗe 338.511.

Rule 338.519 Examꢄnations adoptꢄon; passꢄng scoꢁꢉs; ꢁeꢉxamꢄnation.

(4) If an appꢈicant ꢂr Iꢄcꢉnsurꢉ ꢃꢄꢅs to pass eithꢉr of thꢉsꢉ ꢉxaꢌinatꢄons, hꢉ oꢁ shꢉ shaꢈꢈ

provꢄdꢉ thꢉ board, after each ꢆꢇꢈꢉꢊ attempt and prior to retesting, certiﬁcatꢄon ꢋoꢌ an

appꢁovꢉd ꢉducation program cꢉꢁtꢄꢍꢄng that he or she saꢎisꢆctoꢏiꢈy completed coursꢉs that

pꢁovꢄdꢉ a thorough rꢉvꢄꢉw of thꢉ area oꢁ arꢉas that he or she ꢃiꢈed in thꢉ most rꢉcent

examinatꢄon.

Tꢃis section ꢋeeds to be dropped as eveꢋ tꢃe Nꢄtional Associatioꢋ ofBoaꢢds ofPꢃarmacy

(NABP) alꢴow ꢳr 5 atꢽempts befoꢢe aꢋy ꢢemedꢜation is ꢋeeded. Tꢃis wouꢭd be very costꢴy and

incꢢease tꢃe pꢢessure on passing tꢃis exam. No otꢃer ꢃeaꢴꢵ professꢜoꢋ ꢃas tꢃis sꢝꢥict

requiremeꢋꢽ. Also, none oftꢃe Great Lakes States ꢃave tꢃis strꢜcꢽ ꢢequiremeꢋt. One aꢴꢴows 2

failures, 2 allow 3 ꢶiꢭures aꢈd tꢃe otꢃers ꢷꢸꢭow ꢝhe NABP. Suggest adding back language tꢃat

would aꢭꢭow 5 attempts, suggested ꢭanguage: (4) An appꢭicant who ꢃas ꢋot receꢾved a passing

scoꢇe oꢋ tꢃe NAPLEX aꢋd oꢢ MPJE examꢾnatioꢋs aꢹer 5 atꢽempꢽs sꢃall provide certiﬁcaꢝioꢋ

ꢺoꢻ an approved educaꢽioꢋ proꢰram certiꢼiꢋg tꢃat ꢃe oꢢ sꢃe saꢽꢾsꢿctoriꣀy completed courses

Leading Healthcare

r��h��ealth&

ꢀ� Hospital Association

Sꢁpꢃ. 19, 2019

Dꢁꢒꢅrꢃmꢁꢂt of Liꢏꢁꢂsiꢂg ꢅꢂꢇ Rꢁguꢕꢅꢃoꢆy Affꢅꢄꢆs

Bꢉꢆꢁꢅꢔ of Pꢆofꢁssioꢂꢅꢕ Liꢏꢁꢂsꢎꢂg

Boꢅꢆꢇs ꢅꢂꢇ Coꢚꢚꢎtꢃꢁꢁs ꢈꢁꢏꢃioꢂ

Boꢅꢆꢇ of Phꢅꢆꢚꢅꢏy - Gꢁꢂꢁrꢅl Rulꢁs

ORR #2018-039 LR

Aꢀꢁꢂꢃꢄoꢂ: Poliꢏy Aꢂꢅlysꢃ

P.O. Box 30670

Lꢅꢂsꢎꢂg, Mꢕ 48909

BPL-Boꢅꢆꢇꢈꢉꢊꢋoꢌ@ꢍꢎꢏꢐꢄꢑꢅꢂ.gov

Dꢁꢅꢆ Polꢎꢏy Aꢂꢅlysꢃ:

bꢁhꢅꢕf of ꢃhꢁ Mꢎꢏꢐꢎgꢅꢂ Hꢁꢅꢕth & Hospꢎꢃꢅl Assoꢏiꢅꢃꢎoꢂ (MHA), wꢁ ꢆꢁsꢒꢁꢏꢓꢔꢕꢕy subꢚiꢃ ꢃꢐꢁ

Oꢂ

followꢎꢂg ꢏoꢚꢚꢁnꢃs oꢂ ꢃhꢁ Boꢅꢗꢇ of Phꢅꢆꢚꢅꢏy - Gꢁꢂꢁꢆꢅl Rꢔꢕꢁs.

Uꢂꢇꢁr ꢃhꢁ "Iꢂspꢁꢏꢃꢎons of ꢅꢒꢒꢕiꢏꢅnꢃs ꢅꢂꢇ ꢕiꢏꢁꢂsꢁꢁs" sꢁꢏꢃꢎoꢂ, ꢃhꢁ MHA fꢁꢁls ꢃꢐꢁ iꢂsꢒꢁꢏꢃioꢂ

shoꢔlꢇ ꢅꢕso ꢁxꢏlꢔꢇꢁ ꢇꢅꢃꢅ gꢅꢃꢐꢁꢆꢁꢇ by ꢃꢐꢁ ꢕiꢏꢁꢂsꢁꢇ hꢁꢅlꢃh fꢅꢏilꢎꢃy foꢆ qꢔꢅlꢎꢃy ꢎmꢒꢆovꢁꢚꢁꢂꢃ oꢆ

ꢒrofꢁssionꢅꢕ pꢆꢅꢏꢃꢎꢏꢁ ꢆꢁvꢎꢁw purposꢁs. Thꢁ ꢏollꢁꢏꢃioꢂ of qꢔꢅꢕiꢃy ꢎꢚpꢆovꢁmꢁꢂꢃ ꢇꢅꢃꢅ ꢁꢂꢅblꢁs

provꢎꢇꢁꢆs ꢃo woꢆk ꢃo ꢎꢚꢒꢆovꢁ ꢒꢅꢃiꢁꢂꢃ sꢅfeꢃy ꢅnꢇ rꢁꢇuꢏꢁ ꢃhꢁ iꢂꢏꢎꢇꢁꢂꢏꢁ of ꢅꢇvꢁꢆsꢁ ꢁvꢁꢂꢃs. This

ꢇꢅꢃꢅ ꢏouꢕꢇ bꢁ ꢎnꢏoꢆrꢁꢏꢃꢕy ꢎꢂtꢁꢗꢒrꢁꢃꢁꢇ, whiꢏh ꢚꢅy ꢇꢁꢃꢁꢆ ꢒꢆoviꢇꢁꢆs fꢆoꢚ ꢏolꢕꢁꢏꢃing ꢇꢅꢃꢅ foꢆ quꢅliꢃy

ꢎꢚꢒꢆovꢁꢚꢁnꢃ ꢒurposꢁs. Pꢆofꢁssꢎonꢅl pꢆꢅꢏꢃiꢏꢁ ꢁvꢅluꢅtion ꢎs ꢃꢐꢁ ꢒꢆoꢏꢁss by whꢎꢏh ꢅ hꢁꢅlꢃꢐ

fꢅꢏꢎliꢃy, usiꢂg ꢄꢃs owꢂ mꢁꢇꢎꢏꢅl sꢃꢅff, ꢒꢁrfoꢆꢚs ꢅ ꢒꢁꢁꢆ ꢆꢁvꢎꢁw of ꢅ ꢒꢆiviꢕꢁgꢁꢇ ꢒꢗꢅꢏꢃꢎtꢎoꢂꢁꢆ's

ꢒꢆꢅꢏꢃꢎꢏꢁ for ꢒꢁrforꢚꢅꢂꢏꢁ ꢎꢚꢒꢆovꢁꢚꢁꢂꢃ ꢅꢂꢇ ꢃo ꢁꢂsꢔrꢁ sꢅfꢁ ꢅnꢇ high-quꢅliꢃy pꢅꢃꢎꢁꢂt

pꢆofꢁssꢎoꢂꢅꢕ

ꢏꢅꢆꢁ. Thꢁ ꢇꢅꢃꢅ shouꢕꢇ ꢃo bꢁ lꢁft ouꢃ of ꢃhꢁ iꢂsꢒꢁꢏtioꢂ to ꢁꢂsuꢗꢁ hoꢂꢁsꢃ ꢆꢁsꢁꢅrꢏꢐ ꢅꢂꢇ ꢆꢁsponsꢁs,

wꢐiꢏꢐ wꢎlꢕ uꢕꢃꢎmꢅꢃꢁꢕy lꢁꢅꢇ ꢃo iꢚꢒꢆovꢁꢇ ꢒꢅtiꢁꢂt sꢅfꢁꢃy ꢅꢂꢇ qꢔꢅꢕꢎty. Miꢏꢐꢎgꢅꢂ hosꢒꢎꢃꢅꢕs ꢅꢆꢁ

ꢏoꢚꢚꢎꢃꢃꢁꢇ ꢃo tꢆꢅnspꢅꢗꢁꢂꢏy ꢅnꢇ shꢅꢆꢁ quꢅlꢎꢃy of ꢏꢅꢆꢁ ꢇꢅꢃꢅ ꢃo sꢃꢅꢃꢁ ꢆꢁsiꢇꢁnꢃs ꢅꢃ vꢁꢆꢎfymiꢏꢅrꢁ.oꢗq.

In ꢃꢐꢁ sꢁꢏtioꢂ foꢗ "Iꢂtꢁꢗꢂshꢎꢒ ꢗꢁquꢎꢗꢁꢚꢁꢂꢃs," wꢁ ꢃrusꢃ ꢃhꢁ Boꢅꢆꢇ wꢎꢕl ꢏꢅꢆꢁfulꢕy ꢆꢁviꢁw ꢅnꢇ ꢏoꢂsiꢇꢁꢆ

who ꢎt wꢎll ꢅlꢕow ꢃo vꢁrify ꢐouꢆs. Wꢁ uꢂꢇꢁꢗsꢃꢅꢂꢇ ꢅllowꢎꢂg ꢚoꢆꢁ ꢃhꢅꢂ ꢅ lꢎꢏꢁꢂsꢁꢇ ꢒhꢅꢆꢚꢅꢏy

pꢆꢁꢏꢁpꢃoꢆ oꢆ ꢅppꢆovꢁꢇ ꢁꢇuꢏꢅꢃioꢂ ꢒꢗogꢆꢅꢚ foꢆ fuꢃuꢆꢁ flꢁxibꢎꢕiꢃy bꢔꢃ ꢏꢔrꢗꢁnꢃly, ꢃhꢁ MHA ꢇoꢁs ꢂoꢃ

sꢁꢁ ꢅ ꢏꢅꢃꢁgory of "oꢃhꢁrs" who ꢅꢆꢁ quꢅlꢎfꢎꢁꢇ ꢃo ꢇo ꢃhꢎs.

Uꢂꢇꢁꢆ ꢃꢐꢁ "Prꢅꢏꢃiꢏꢁ of Pꢐꢅꢆꢚꢅꢏy" ꢈꢁꢏtioꢂ, ꢃꢐꢁ ꢂꢁw Noꢖꢐ Aꢚꢁꢗꢎꢏꢅꢂ Phꢅꢆꢚꢅꢏꢎsꢃ Lꢎꢏꢁꢂsꢔꢆꢁ

Exꢅꢚiꢂꢅꢃioꢂ (NAPLEX) ꢅnꢇ Miꢏhigꢅn Mꢔlꢃꢄsꢃꢅꢃꢁ Pꢐꢅrꢚꢅꢏy Jurisꢒꢆꢔꢇꢁꢂꢏꢁ

Exꢅꢚꢄꢂꢅꢃioꢂ (MPJE)

ꢒꢅssꢎꢂg rꢁquiꢆꢁꢚꢁnꢃs ꢆꢅisꢁꢇ soꢚꢁ ꢅꢒpꢆꢁꢐꢁꢂsꢎon ꢅꢚong hospiꢃꢅꢕ mꢁꢚbꢁꢆshꢎꢒ. Wꢐiꢕꢁ wꢁ

ꢆꢁsꢒꢁꢏꢃ ꢃꢐꢁ ꢒꢆoꢒosꢅl ꢃo sꢅfꢁguꢅꢗꢇ ꢏoꢚpꢁꢃꢁnꢃ ꢒhꢅꢆꢚꢅꢏisꢃs ꢃo ꢁꢂꢃꢁꢆ ꢃꢐꢁ woꢗkfoꢆꢏꢁ, ꢃhꢁ MHA

wꢅnꢃs ꢃo ꢁꢂsuꢆꢁ qꢔꢅlifꢎꢁꢇ ꢏꢅꢂꢇꢎꢇꢅꢃꢁs ꢅrꢁ ꢂoꢃ iꢂꢅꢇvꢁꢗꢃꢁꢂꢃly vꢁꢃꢃꢁꢇ oꢔꢃ. Oꢃhꢁꢆ vꢅꢆꢎꢅbꢕꢁs, iꢂꢏlꢔꢇꢄꢂg

ꢁꢇꢔꢏꢅꢃioꢂ, ꢒꢆꢎoꢆ ꢁꢚployꢚꢁnꢃ, ꢎꢂꢃꢁꢆꢂshiꢒs, rꢁsꢎꢇꢁnꢏꢎꢁs ꢅꢂꢇ skills whꢄꢏh ꢅrꢁ vꢅluꢅbꢕꢁ ꢃo hosꢒiꢃꢅꢕs

ꢅrꢁ noꢃ ꢇꢁfiꢂꢁꢇ by ꢁxꢅꢚs ꢅloꢂꢁ. Aꢇꢇꢎꢃꢎoꢂꢅꢕꢕy, oꢂꢁ ꢇꢅy of ꢒooꢗꢘpꢁꢙoꢆꢚꢅꢂꢏꢁ ꢇuꢆiꢂg ꢅ ꢃꢁsꢃ ꢏꢅꢂ

hꢅꢒpꢁꢂ, ꢅꢂꢇ sꢃꢔꢇꢁꢂꢃs ꢇꢁsꢁrvꢁ ꢅꢂoꢃꢐꢁꢆ ꢃꢆy bꢁfoꢆꢁ ꢃhꢁy ꢅꢆꢁ ꢆꢁquꢄrꢁꢇ ꢃo ꢒꢆoviꢇꢁ sꢅꢃisfꢅꢏꢃoꢆꢎꢕy

ꢏoꢚplꢁꢃꢁꢇ ꢏoꢉꢆsꢁs iꢂfoꢗꢚꢅꢃꢎoꢂ ꢃo ꢃhꢁ Boꢅꢆꢇ.

Brian Peters, Chief Executive Ofﬁcer

MHA Capitol Advocacy Center I 110 W. Michigan Avenue, Suite 1200 I Lansing, Ml 48933 I (517) 703-8601 I www.mha.or

g

LICENSING AND REGULATORY AFFꢉIRS

ꢀꢁꢂꢃꢄꢅꢆ'ꢇ OFFICE

PꢈMꢉꢃꢊ - GENERAL RULES

Filed with the Secrꢂtary of Sꢆꢄte on

Thꢂse rules become effective immediꢄtely upon ﬁling with the Secreꢆꢄry ofStꢄte unless ꢄdopꢆꢂd

under section 33, 44, or 45(ꢄ)(6) of 1969 PA 306. Rules ꢄdopted under these sections become

effꢂctive 7 ꢐꢄys ꢀꢁꢂꢃ ﬁling withthe Secrꢂtꢀry ofStꢄte.

(By ꢄꢅꢆꢇoꢈꢉꢊ ꢋoꢌꢍꢎꢏꢂꢐon the diꢏꢂctor ofthe dꢂpꢄrtment oflicensingand regulꢄtory ꢄﬀꢄirs by

sectionꢗ16145, 16148,16174, 16175, 16178 1ꢐ182 1618ꢐ, 17722, 17731, 17737, 17746,

,

17757, 17760, ꢋꢌdꢍꢎꢏꢏꢐꢑ of1978 PA 368, MꢃL

17748 17748a, 17748b, 17751 17753

,

333.16145, 333ꢩ16148, 333.16174 333.1ꢐ175, 333,16178 333.16182 333.1ꢐ186 333.17722,

,

333.17731, 333.17737 333.17746, 333.17748, 333.17748a 333.17748b, 333.17751 333.17753

,

333.17757 333.177ꢐ0 ꢒꢓ333.17721333.17767, aꢌd Executive Order Nos. 1991-9, 1996-2

,

)

2003 QI 2003-1 and 2011-4, MCL 338.3501, 445.2001, 445.2011, and MꢃL 445.2030

,

;

R338.486 ofthe Michigan Administrꢋtive Code is amended ꢋnd R 338.471 R 338.471a,

,

R338.471b, R 338.472, R 338.473, R338.473a R 338.473b, ꢆ 338.473c R 338.473d

,

R338.477a, R 338.477b R 338.477c

,

R338.474 R338.474a, R 338.475, R338.477

,

R338.478 R338.479 R 338.479ꢋ, R 338.479b, R338.4ꢑ9c, R338.480

R 338.477d

,

R338.490, R 338.493a, R 338.493b R 338.493c

,

R 338.480a, R 338.481, R 338.482 R 338.489

,

;

R 338.493d, R 338ꢩ493f, R 338.493g and R338.500 of the Code are rescinded and R 338.501

,

R 338.503 R 338.505, R338.511, R338.513, R338.515, R 338.517, R 338.519 R 338.521

,

R 338.536,

R338.523, R 338.525 R 338.531 R338.532, R338.533 R 338.534 R 338.535

,

R 338ꢩ537, R338.538 R 338.539 R 338.551 R 338.553, R338.555, R338.557, R 338.559,

,

R 338.569, R338.571, R338.573

R 338ꢩ561, R 338.563 R338.565, R 338.567

ꢆ 338.575

,

R338.582 R 338.583 R 338ꢩ584, R338.585 R338.586, R338.587, R 338.588,

R 338.577

,

338.589, ꢋnd ꢆ 338.590 are added to the Cꢖde to reꢋd ꢋs ꢔlꢕꢖwꢗ:

R

PART I. GꢂNꢂꢆAL PROVISIONS

R 338.471 ꢀepꢁꢂꢃrꢄ Rescinded.

- ꢑꢒꢓ 1, Alꢕ ꢔꢕꢖꢗ ꢘꢙ ꢚꢛHꢜꢝꢞꢟꢠꢡꢢ prꢹviꢠusly꤅ꢦꤛꤊt꤁dꢣ t꣸e stꢴꢾe Bꢤꢥꢦ sfꢧꢨꢩꢪꢫꢬꢭ ꢮꢯꢰꢱꢲꢳꢴꢵꢶꢷ

ꢸꢹꢺꢻꢼ ta ꢽ ꢾꢿꣀꣁꣂꣃ꣄ ꢪFꢹ hꢹrꢹ6꣼ꣅ꣆꣇꣈ꢝ꣉꣊꣋ ꣌꣍ ꣛ꣿt꣎꣏꣐꣑

R 338.47 lꢄ D꣒꣓꣔꣕꣖꣗꣘Rescinded.

- Rulꢓ l꣺. Aꢗ aꢗeꢦ iꢡ ꣙꣚꣛꣜꣝꣞꣟꣠:

- E꣡ "Accꣾeꢦitꢶd꣢꣣꣤꣚꣥ꢶ er seheꢠl ꣦꣧꣨꣩꣪꣫ꢫ꣬꣭mꢶꢪꢡs a꣮꣖꣯꣰꣱ꣲ ꤓr ꢢꣳꣴ꣖ꣵ ꣴꣶꣷ꣸꣹꣺ꣻ꣼th꣺t iꢗ

ꣽꣻꣾꣿꢦ꤀ꢞ꤁꤂ Sy ꤓr ꢮ꤃ e꣺ꢡ8iꢼ꣺ꢞꣿ ꤄ꢞ꤅꤆꤇ By ꢘaeeꣾeꤕiꢞꢪꢞiꣴa eeuneil ꤈꤉ ꤊꤋꤌ꣺ꤍ ꣊duc꣺ꢞiꤛn, ꤎ

(

)(

ꢙꢚꢛꢜꢝR338A71 1 a).

- ꤏꤐ ꤑꤒꤓꤔꤕꤖꤗ꣚ꤘꤙ t꣸꤁ ꤚꤛꤜꤝ ꤞꤟꤠꢨꤡꤢꤣꤤ

e "Code" ꢞꢟꢠꢡ 1978 ꢢꢣ 368, ꢤꢥ 333.1101 to ꢦꢧꢨꢩꢪꢫꢬꢭꢮ

( )

58

(8) The drug box must reꢄain sealed at all tiꢎes, except when in use. All drugs reꢎoved

ꢀoꢁ the box ꢁust be recorded on a medication use forꢄ. Afteꢃ completing the ꢂꢃꢄꢅ the

physician, registered nurse or physician's assistant who ꢃeꢄoved the drug ꢄust place the

forꢄ in the drug box and seal the box with a nonreusable, tamper-evident seal or sealing

system which is a coloꢃ that designates that the box has been opened,

(9) Each drug box undeꢃ the control of the pharꢄacy must be exaꢄined at least weekly to

ensure that the seal which designates that the box has not been opened is still intact and the

expiꢃation date has not been exceeded. If the expiꢃation date has been exceeded or the box

has been opened, the box ꢎust be returned to the phaꢃmacy. The written prescription ꢆꢇ

all dꢃugs that have been administeꢃed froꢄ the drug box must accompany the drug box

when it is returned to the pharꢄacy after opening.

(10) The pharmacy shall ꢎaintain a perꢄanent record ofdrug box exchanges on

box exchange log. The ꢃecoꢃd must contain all of the following inforꢄation:

(a) The number of the box.

a drug

(b) The name ofthe hospice to which the box is released.

(c) The date the box is released to the hospice.

(d) The name and signatuꢃe ofthe phaꢃmacist who releases the box to the hospice.

(e) The expiration date assigned.

(f) The date the box is returned to the pharꢄacy ꢈꢉ ꢃestocking.

(g) The naꢄe and signatuꢃe ofthe phaꢃmacist who received the box ꢊꢋ restocking.

(11) Upon return of the drug box to the phaꢃmacy, the phaꢃmacist shall reconcile the

drugs dispensed ꢌoꢄ the drug box with the prescꢃiptions of the attending physician or

medical director ofthe hospice. The phaꢃꢄacistshall note that the prescꢃiptions were

dispensed ꢍoꢎ the hospice dꢃug box on the back of the pꢃescriptions. The prescꢃiptions

must be ﬁled in the saꢄe manneꢃ as other prescriptions arc ꢎaintained at the pharꢎacy.

"a pharmacy, or at the samꢃ physical address as the pharmacy provided that the location of

thꢃ devicꢃ is owꢁꢃd aꢅd opꢃratꢃd by the samꢃ legal ꢃꢅtity as thꢃ pharmacy."

Proposed Language: R338.588 (3) A pharmacy that operates an automatꢃd device uꢁder

this

section shall ꢅotify thꢃ depaꢀmeꢁt of thꢃ automatꢃd dꢃvicꢃ's locatioꢁ oꢁ a form providꢃd

thꢃ departmeꢁtꢆ Aꢁ automatꢃd devicꢃ located withiꢁ a licꢃꢁsed pharmacy must be used

by

oꢅly

pharmacist.

by a pharmacist or his or hꢃr pharmacy pꢃrsoꢅꢁꢃl undꢃr thꢃ pꢃrsoꢁal chargꢃ of a

Comment: Thꢃ current defiꢁition "automated device" in the Michigaꢁ Pꢇblic Health Code aꢅd

in thꢃ rulꢃs as proposꢃd ꢃncompassꢃs sꢃveral devices that may be used in workflow for tasks

other

than thꢃ delivꢃry of a mꢃdication to patient or other healthcare providꢃr (e.g., coꢇꢁtiꢁg

machiꢅꢃs aꢁd packagiꢁg dꢃvicꢃs opꢃrated by pharmacy staﬀ as part of the dispꢃꢁsiꢁg

procꢃss). Wꢃ feel that to registꢃr ꢃach of thꢃse devices with the dꢃpartmꢃꢁt goꢃs beyoꢁd thꢃ

iꢁteꢅt of the Board aꢁd thꢃ Depaꢂmeꢁt and will cause dꢃvicꢃs that do ꢁot rꢃquire departmꢃnt

oversight to bꢃ ꢃrroꢁeously rꢃgistꢃrꢃd with thꢃ Dꢃpartmꢃꢁt. To corrꢃct this, wꢃ recommꢃnd

that Rulꢃ 88, Subrulꢃ (3) bꢃ modifiꢃd to read: "A pharmacy that operates aꢁ automated devicꢃ

uꢁdꢃr this sꢃctioꢁ to dꢃlivꢃr a drug or device directly to a patieꢅt or other healthcare providꢃr

shall notify thꢃ dꢃpartmeꢁt of the aꢇtomatꢃd devicꢃ's locatioꢁ on a form providꢃd by the

dꢃpaꢄmꢃꢅtꢆ.. "

Proposed Language: R338.588 (7) Rꢃcords and ꢃlꢃctroꢁic data kꢃpt by automated dꢃvices

must meꢃt all of thꢃ following rꢃquiremꢃꢁts:

(a) All ꢃvꢃnts iꢅvolviꢁg accꢃss to thꢃ contents of thꢃ aꢇtomatꢃd dꢃvicꢃs must be recorded

ꢃlꢃctroꢅically.

(b) Rꢃcords must bꢃ maintained for 5 yꢃars by thꢃ pharmacy aꢁd must be rꢃtrievablꢃ on

demand for rꢃview by aꢅ agꢃꢁt of the boardꢆ Thꢃ rꢃcords must iꢁcludꢃ all of thꢃ following

iꢁformatioꢁ:

Comment: To provide consistꢃncy iꢁ thꢃ rꢃcord keeping rꢃquiremeꢁts for pharmaciꢃs aꢁd

dispꢃꢅsing prescribers, we recommꢃꢁd that Rulꢃ 88, Subrule (7)(b) bꢃ modified to rꢃad:

mꢇst bꢃ maintaiꢁꢃd for 5 years by the pharmacy or dispꢃꢁsiꢅg prescriber aꢅd must

"Rꢃcords

bꢃ retrievable oꢁ demand for rꢃview by aꢁ ageꢁt of the board... "

Rꢃspꢃctfully sꢇbmꢈꢉedꢊ

Eric Roath, PharmD, MBA

Cliꢁical Care Coordinator

SpartaꢁNash

1550 Gꢃzon Parkway, Suitꢃ E-100

Wyoming, Ml 49509

Phonꢃ: 616-878-2324 Fax: 616-878-8850

Page 3 of 3

(a) stablish that the he or she is cuꢂrently licensed in anotheꢂ staꢁe and was iniꢁially licensed by

E

examination in anoꢁher staꢁe.

(b) Pass ꢁhe MPJE as ꢂequiꢂed under R 338.519.

Have his oꢂ her license veꢂiﬁed by the licensing agency ofany staꢁe ofthe United Sꢁaꢁes in which the

(c)

applicant holds oꢂ has eveꢂ held a license to pꢂactice phaꢂmacy. This includes, buꢁ is not limiꢁed to,

showing pꢂoof of any disciplinaꢂy action taken oꢂ pending againsꢁ the applicant.

(d) Submit the MPJE examination score ꢂepoꢂꢁ and NꢀP Iicensuꢂe ꢁꢂansꢃꢄ ꢂepoꢂt to the depaꢂꢁment.

Is this ꢀꢁcꢂenꢃ for ꢄꢅꢆeꢇꢈ?

Thank you,

Neal

Neal Watson, Member Liaison

847/391-4481

National Association of Boards of Pharmacy

1600 Feehanville Dr, Mount Prospect, IL 60056

=======� I jbolin@nabp.pharmacy

"'

From: Ditschman, Andria (LARA) <DitschmanA@michigan.gov>

Sent: Thursday, October 3, 2019 7:59 AM

To: Watson, Neal <nwatson@nabp.pharmacy>

Subject: RE: Public Comment Period Pharmacy Rules

Hi Neal,

I have not yet received your comments regarding the pharmacy rules. Just a reminder.

Andria M. Ditschman, JD

Senior Analyst

Boards and Committees Section

Bureau of Professional Licensing

Michigan Department of Licensing and Regulatory Aﬀairs

611 W. Ottawa Street

P.O. Box 30004

Lansing, Michigan 48909

2

Pharmacy General Rules - ORR 2018-039 LR

Public Comment Summary

Rules Committee’s Recommendations and Board’s Response to October 4, 2019 Public Comments

Testimony/Comments Received:

Rose M. Baran, PharmD, MA, Assistant Professor, College of Pharmacy, Ferris State University

Alyssa R. Baskerville, PharmD Candidate

Adam Carlson, Senior Director, Government & Political Affairs, Michigan Health & Hospital Association (MHA)

Thomas R. Clark, RPh, MHS, BCGP, Senior Director, Board of Pharmacy Specialties (bps)

Maher Daman, PharmD, Ferris State University

Deeb D. Eid, PharmD, Assistant Profession, Ferris State University

Justin Kuhns, PharmD, Lab Director, Portage Pharmacy

Joel Kurzman, Director, State Government Affairs, National Association of Chain Drug Stores (NACDS)

Bradley McCloskey, PharmD, President/CEO

Neal Mehta, Pharm D

Ned Milenkovich, PharmD, JD, Much Shelist, P.C,

Joseph C. Osborne, PharmD, Candidate, Ferris State University

Scott Popyk, Health Dimensions/ member MPA and International Academy of Compound Pharmacists

Eric Roath, PharmD, MBA, Clinical Care Coordinator, SpartanNash

Brian Sapita, Government Affairs Manager, Michigan Pharmacists Association (MPA)

Tom Sullivan, Michigan Surgical Hospital and Insight for Neurosurgery and Neurological Sciences

Larry Wagenknecht, Pharmacist, FMPA, FAPhA, Chief Executive Officer, MPA

Neal Watson, Member Liaison, National Association of Boards of Pharmacy (NABP)

Rule 338.486

“Medical institution” and “pharmacy services” defined; pharmacy services in medical institutions.

Rule Numbers

Section (1)(a)

Commenter

Eid/Ferris

Comment

Add “home of the aged” to the definition of “medical institution” as LARA has a Division of Adult

Foster Care and Homes for the Aged. Provides inclusivity.

Section (3)

Baran/Ferris

Delete “inpatients” and replace with “patients of a medical institution.” Do not delet “who is on the

May 8, 2020

premises.” Removing “who is on the premises” does not allow the technicians to remain in the

pharmacy working while the pharmacist is at meeting in the hospital or on the floor or etc. This

negates the original intent to allow the pharmacist to be in the hospital but not in the pharmacy and

let the technicians remain to continue drug preparation for the pharmacist review. This allows the

pharmacist of small hospitals to attend meetings and other issues outside of the pharmacy but on

the hospital premises. This would enable small hospitals to stay open and serve the public health of

the community.

Sapita/MPA

Do not remove “who is on the premises.”

Rules Committee (1)(a): The Rules Committee does not agree with the comment to add “home of the aged” to the definition of “medical

Response

institution,” as the definition includes “health facility,” which under Article 17 of the Public Health Code includes a

home for the aged.

(3): The Rules Committee agrees with the comments to not remove “who is on the premises.”

R 338.486 “Medical institution” and “pharmacy services” defined; pharmacy services in medical institutions.

Rule 16. (1) As used in this rule:

(a) "Medical institution" means a hospital, skilled nursing facility, county medical care facility, nursing home, freestanding

surgical outpatient facility, hospice, or other health facility which that is licensed or approved by the state, and which directly or

indirectly provides or includes pharmacy services.

(b) "Pharmacy services" means the direct and indirect patient care services associated with the practice of pharmacy.

(2) Pharmacy services in a medical institution must shall be directed and provided by a licensed pharmacist.

(3) Pharmacy personnel who assist the pharmacist by performing delegated functions in the care of inpatients patients of a

medical institution shall be supervised by a pharmacist who is on the premises of the medical institution.

(4) The pharmacist who directs the pharmacy services shall develop, implement, supervise, and coordinate all of the services

provided, including, at a minimum, all of the following:

(a) Dispensing medications in a form that minimizes additional preparation before administration to the patient, including the

admixture of parenterals.

(b) Obtaining the prescriber's original medication order, a direct carbonized copy, an electromechanical facsimile, or other

electronic order transmission. Security measures shall must be in place to ensure that system access by unauthorized individuals is

not allowed.

2

(c) Interpreting and reviewing the prescriber's medication orders and communicating problems with these orders to the physician or

nurse prescriber before administration of first doses. If the interpretation and review will cause a medically unacceptable delay, then

a limited number of medications may be stocked at the patient care areas for the administration of first doses. These medications

Medications shall must be provided in a manner that ensures security and immediate availability, such as sealed or secured

medication kits, carts, or treatment trays. A pharmacist shall routinely inspect the medications and, after use, shall verify the contents

and replace the medications as necessary.

(d) Delegating the stocking of an automated device. Technologies must be in place and utilized to ensure that the correct

drugs are stocked in their appropriate assignment utilizing bar-coding or another board-approved error prevention

technology that complies with R 338.3154.

(e) Monitoring medication therapy to promote positive patient outcomes while evaluating clinically significant chemical and

therapeutic incompatibilities.

(e) (f) Establishing the specifications for the procurement of all pharmaceuticals and related biologicals and chemicals approved for

use in the medical institution.

(f) (g) Not less than once every 6 months, inspecting Inspecting all areas in the medical institution where medications are stored to

verify compliance with the standards for the safe use and storage of the medications, not less than once every 6 months.

(g) (h) Maintaining proper security for all medications stored or kept within the medical institution.

(h) (i) Providing educational programs regarding medications and their safe use.

(i) (j) Providing a method by which medications can be obtained during the absence of a pharmacist in a medical institution where a

pharmacist is not available 24 hours a day. The method shall minimize the potential for medication error. During the absence of a

pharmacist, the services of a pharmacist shall must be available on an on-call basis. Only a limited number of medications that are

packaged in units of use shall must be available. The medications shall must be approved and reviewed periodically as deemed

necessary, but not less than once a year, by an appropriate interdisciplinary practitioner committee of the medical institution. The

medication shall must be kept in a securely locked, substantially constructed cabinet or its equivalent in an area of limited access in a

centralized area outside the pharmacy. Each medication shall must be labeled to include the name of the medication, the strength, the

expiration date, if dated, and the lot number. A written order and a proof of removal and use document shall must be obtained for

each medication united unit removed. The order and document shall be reviewed by the pharmacist within 48 hours of removing

medication from the cabinet or its equivalent. The pharmacist who directs pharmacy services in the medical institution shall designate

the practitioners who are permitted to remove the medication. A pharmacist shall audit the storage locations as often as needed to

guarantee control, but not less than once every 30 days.

(5) Upon recommendation of an interdisciplinary practitioners practitioners’ committee, the pharmacist who directs pharmacy

services in the medical institution shall adopt written policies and procedures to promote safe medication practices, to conduct

3

medication utilization review, to approve medications for the medical institution's formulary or medication list, and to promote

positive patient outcomes. A pharmacist shall meet with the committee at least quarterly to conduct assigned responsibilities.

(6) A pharmacy shall ensure that every medication dispensed is identified with its name and strength labeled on the container in

which it is dispensed or on each single unit package. A pharmacy that is engaged in drug distribution to medical institutions which

use unit-of-use packaging shall place identification on the label of its package to allow the package to be readily traced. The name of

the patient, or a unique identifier, shall must be labeled on the medication container. The container may be the individual patients'

patient’s assigned medication drawer. The directions for use shall must be on the label of the container if the directions are not

communicated in another effective manner. If the medication is to be self-administered, then directions for use shall must be on the

container. The preceding provisions of this subrule are minimum labeling standards only and do not supersede other applicable laws

or rules.

(7) A pharmacist shall personally supervise the destruction of unused portions of prescription medication, other than controlled

substances under part 71 of the code, dispensed to patients. However, medications in single-unit packages and intravenous solutions

which are designed to be tamper-evident and which show no evidence that tampering has occurred may be returned to stock.

Medications that leave the medical institution or its legal affiliates may not be returned to stock for redispensing dispensing.

(8) The licensed pharmacist who directs pharmacy services in the medical institution shall make the policies, procedures, and

written reports required by this rule available to the board of pharmacy, upon request.

Board Response

(1)(a): The Board does not agree with the comment to add “home of the aged” to the definition of “medical

institution,” as the definition includes “health facility,” which under Article 17 of the Public Health Code

includes a home for the aged.

(3): The Board agrees with the comments to not remove “who is on the premises.”

Rule 338.501

Rule Numbers

Section (1)(j)

Section (1)(e)(4)

Definitions.

Commenter

Sapita/MPA

Comment

“Virtual manufacturer” is not defined in the statute and should be.

Milenkovich/Much USP has indicated they intend to classify all flavorings of conventionally manufactured

Shelist

medications as nonsterile compounding. Fourteen state boards of pharmacy have language on their

books excluding flavoring from the definition of compounding. The request is to implement a

regulation excepting the safe administration of flavorings added to conventionally manufactured

medications from the definition of compounding. The Board can achieve this by narrowing the use

4

of flavoring agents to conventionally manufactured and commercially available liquid medications

and by setting conditions to ensure safe administration of flavorings (ie favoring agents must be

nonallergenic and inert, not exceeding 5% of a drug product’s total volume).

Rules Committee (1)(j): The Rules Committee made no recommendation on the comment as the comment was withdrawn.

Response

(1)(e)(4): The rules committee agrees with the comment to exclude flavoring as an exception to the compounding rule as

long as there is no other product manipulation.

(d) “Compounding” means the preparation, mixing, assembling, packaging, and labeling of a drug or device by a pharmacist

under any of the following circumstances:

(i) Upon the receipt of a prescription for a specific patient.

(ii) Upon the receipt of a medical or dental order from a prescriber or agent for use in the treatment of patients within the

course of the prescriber's professional practice.

(iii) In anticipation of the receipt of a prescription or medical or dental order based on routine, regularly observed

prescription or medical or dental order patterns.

(iv) For the purpose of or incidental to research, teaching, or chemical analysis and not for the purpose of sale or dispensing.

(e) "Compounding" does not include any of the following:

(i) Except as provided in section 17748c of the code, MCL 333.17748c, the compounding of a drug product that is essentially a

copy of a commercially available product.

(ii) The reconstitution, mixing, or other similar act that is performed pursuant to the directions contained in approved

labeling provided by the manufacturer of a commercially available product.

(iii) The compounding of allergenic extracts or biologic products.

(iv) Flavoring agents added to conventionally manufactured and commercially available liquid medications. Flavoring

agents must be nonallergenic and inert, not exceeding 5% of a drug product’s total volume.

(j) “Virtual manufacturer” means a person who engages in the manufacture of prescription drugs or devices and meets all of

the following:

(i) Owns either of the following:

(A) The new prescription drug application or abbreviated new prescription drug application number.

(B) The unique device identification number, as available, for a prescription device.

(ii) Contracts with a contract manufacturing organization for the physical manufacture of the drugs or devices.

(iii) Is not involved in the physical manufacture of the drugs or devices.

5

(iv) At no time takes physical possession of or stores the drugs or devices.

(v) Sells or offers for sale to other persons, for resale, compounding, or dispensing of, drugs or devices, salable on

prescription only.

Board Response

(1)(j): The comment was withdrawn by the commenter.

(1)(e)(4): The Board agrees with the comment to exclude flavoring as an exception to the compounding rule as

long as there is no other product manipulation.

Rule 338.503

Prescription drugs and devices; return or exchange for resale prohibited.

Rule Numbers

Commenter

Comment

Add Section (2)(d) Baran/Ferris

Add to this rule the return of drugs for a manufacturer recall that is down to the patient level or

when the wrong medication was dispensed to the patient. This then would align with 21 CFR part

1317. Add: (d) The provisions of subsection (1) shall not apply to drugs returned when the wrong

medication was dispensed to the patient or in the instance of a drug recall. In no instance may

returned drugs be reused or returned to active stock.

This would encourage the removal of harmful drugs.

Rules Committee (2)(d): The Rules Committee agrees with the comment to add “(d) Drugs returned when the wrong medication was

Response

dispensed to the patient or in the instance of a drug recall. In no instance may returned drugs be reused or returned to

active stock.” The addition of this language will allow the return of drugs in 2 additional circumstances that are not

currently in the rules, subject to any controlled substances exceptions or limitations.

R 338.503 Prescription drugs and devices; return or exchange for resale prohibited.

Rule 3. (1) Prescription drugs or devices that have been dispensed and have left the control of the pharmacist must not be

returned or exchanged for resale.

(2) This rule does not apply to any of the following:

(a) A pharmacy operated by the department of corrections or under contract with the department of corrections or a county

jail, as provided in section 17766d of the code, MCL 333.17766d.

(b) A pharmacy or charitable clinic that participates in the program for the utilization of unused prescription drugs, as

provided in section 17775 of the code, MCL 333.17775.

6

(c) A pharmacy or health facility that participates in the cancer drug repository program, as provided in section 17780 of the

code, MCL 333.17780.

(d) Drugs returned when the wrong medication was dispensed to the patient or in the instance of a drug recall. Subject to R

338.486(7), in no instance may returned drugs be reused or returned to active stock.

Board Response

The Board agrees with the comment to add “(d) Drugs returned when the wrong medication was dispensed to the

patient or in the instance of a drug recall. In no instance may returned drugs be reused or returned to active

stock.” The addition of this language will allow the return of drugs in 2 additional circumstances that are not

currently in the rules, subject to any controlled substances exceptions or limitations.

Rule 338.505

Rule Numbers

R 338.505

Inspection of applicants and licensees.

Commenter

Baskerville

Comment

This draft rule mentions that the approved entity may enter any facility that is eligible for inspection

“at reasonable times”. The statement about the time needs to be more specific because “reasonable”

is largely open to interpretation. Add 9:00 a.m.-5:00 p.m. after the phrase “reasonable times”. It

should read “…may enter between the reasonable times of 9:00 a.m. and 5:00 p.m., any building…”

Modify to:

Section (e)

Carlson/MHA

(e) Research data.

(f) Information gathered by a licensed health facility for quality improvement or professional

practice review.

Rules Committee The Rules Committee does not agree with the comment limiting the accessibility for inspections due to safety concerns.

Response

(1)(f): The Rules Committee agrees with the comment to add (f) above.

R 338. 505 Inspection of applicants and licensees.

Rule 5. The board, board inspector, board agent, or approved entity pursuant to R 338.532, may enter at reasonable times,

any building, place, or facility that is owned or controlled by any applicant for, or holder of, a license to make an inspection to

enable the board to determine if the applicant possesses the qualifications and competence for the license sought or to

determine whether a license holder is and has been complying with the code and rules. The inspection must concern only

matters relevant to the applicant’s or license holder’s practice of pharmacy, manufacturing, and wholesale distributing of

drugs and devices saleable by prescription only.

7

(1) The inspection must not extend to any of the following information:

(a) Financial data.

(b) Sales data other than shipment data.

(c) Pricing data.

(d) Personnel data other than data as to the qualifications of personnel performing functions subject to the acts and rules

enforced by the board.

(e) Research data.

(f) Information gathered by a licensed health facility for quality improvement or professional practice review.

(2) An applicant or license holder shall permit and cooperate with the inspection.

Board Response

The Board does not agree with the comment to limit the accessibility for inspections due to safety concerns.

(1)(f): The Board agrees with the comment to add (f) above that does not allow the department to access

information gathered for quality improvement or professional practice review during an inspection as this

information is not pertinent to an inspection to determine if an applicant possesses the qualifications and

competence for the license being sought or to determine if the licensee is complying with the code and rules.

Department

Response

(1)(f): The Department does not agree with adding the suggested language as it may be relied on by a pharmacy

for a basis to refuse to comply with a Department investigative subpoena. Although Article 17 protects hospital

peer review from disclosure in Department investigations, the Department is not aware of this privilege being

extended to pharmacies within such facilities. Additionally, the statutory privilege provided to hospitals relates

to only data tied to the reduction of mortality rate and improvement of patient care.

Rule 338.511

Training standards for identifying victims of human trafficking; requirements.

Rule Numbers

Commenter

Eid/Ferris

Sapita/MPA

Comment

It is not clear if this training is required for a limited license, see R 338.513.

Rule not consistent with CE rules – consider same verbiage.

Section (3)

Rules Committee The Rules Committee agrees with the comment to clarify that a limited licensee must meet the human trafficking training

Response

requirement. No change to this rule is necessary. A reference to R 338.511, which requires the training, is recommended

in R 338.513.

8

(3): The rules committee agrees with the comment that the dates in this rule and the dates in the pharmacist CE rules

must be consistent. No change to this rule is necessary.

R 338.511 Training standards for identifying victims of human trafficking; requirements.

Rule 11. (1) Pursuant to section 16148 of the code, MCL 333.16148, an individual seeking licensure or who is licensed shall

complete training in identifying victims of human trafficking that meets the following standards:

(a) Training content must cover all of the following:

(i) Understanding the types and venues of human trafficking in the United States.

(ii) Identifying victims of human trafficking in health care settings.

(iii) Identifying the warning signs of human trafficking in health care settings for adults and minors.

(iv) Resources for reporting the suspected victims of human trafficking.

(b) Acceptable providers or methods of training include any of the following:

(i) Training offered by a nationally recognized or state-recognized, health-related organization.

(ii) Training offered by, or in conjunction, with a state or federal agency.

(iii) Training obtained in an educational program that has been approved by the board for initial licensure, or by a college or

university.

(iv) Reading an article related to the identification of victims of human trafficking that meets the requirements of subdivision

(a) of this subrule and is published in a peer reviewed journal, health care journal, or professional or scientific journal.

(c) Acceptable modalities of training may include any of the following:

(i) Teleconference or webinar.

(ii) Online presentation.

(iii) Live presentation.

(iv) Printed or electronic media.

(2) The department may select and audit a sample of individuals and request documentation of proof of completion of

training. If audited by the department, an individual shall provide an acceptable proof of completion of training, including

either of the following:

(a) Proof of completion certificate issued by the training provider that includes the date, provider name, name of training,

and individual’s name.

(b) A self-certification statement by an individual. The certification statement must include the individual’s name and either

of the following:

9

(i) For training completed pursuant to subrule (1)(b)(i) to (iii) of this rule, the date, training provider name, and name of

training.

(ii) For training completed pursuant to subrule (1)(b)(iv) of this rule, the title of article, author, publication name of peer

review journal, health care journal or professional or scientific journal, and date, volume, and issue of publication as

applicable.

(3) Pursuant to section 16148 of the code, MCL 333.16148, the requirements specified in subrule (1) of this rule apply for

license renewals beginning in January 1, 2020 and for initial licenses issued after November 13, 2022.

Board Response

The Board agrees with the comment to clarify that a limited licensee must meet the human trafficking training

requirement. No change to this rule is necessary. A reference to R 338.511, which requires the training, is

recommended in R 338.513.

(3): The Board agrees with the comment that the dates in this rule and the dates in the pharmacist CE rules

should be consistent.

Rule 338.513

Educational limited license; application and renewal; practices.

Rule Numbers

Section (1)(a) and Sapita/MPA

Commenter

Comment

Remove “90 days” and replace with “180 days.”

(2)(a)

Section (1)(a) and Baskerville

(2)(a)

The rule only allows renewal of a limited education license within 90 days after graduating from an

approved educational program. Ninety days is not enough time because if a graduate does not pass

the NAPLEX, they must wait 45 days to take the exam again. The window is tight, and it should be

longer to accommodate more graduates. Modify 1a and 2a to 180 days instead of 90 days.

Replace with “An educational limited licensee must engage in the practice of pharmacy under the

supervision of a pharmacist preceptor as defined in section 17708(1) of the code and only under the

personal charge of a pharmacist.”

Section (3)

Section (4)

Sapita/MPA

Roath/SpartanNash In the context of the Proposed Rule 13, this subrule seems to require that an educational limited

licensee (pharmacy intern) only practice under the direct personal supervision of a pharmacist

licensed as a preceptor. Previously, this requirement only extended to pharmacy interns working

towards the intern hours required to obtain their full pharmacist license. The language, as

proposed, would create a barrier for pharmacy interns seeking to gain additional experience

10

through paid internships aside from what is required by their academic programs. Also, this

seems to conflict with Rule 15 (3) which creates provisions for a pharmacy intern to submit

hours that were not conducted under the personal charge of a preceptor licensed in the state. As

such, we recommend that Rule 13, Subrule (4) be removed from the rules as proposed.

Add Section (6)

Baran/Ferris

Eid/Ferris

Need to add the human trafficking requirement.

Add: (6) Applicants need to complete the training in human trafficking for licenses issued after

November 13, 2022 as required in Rule 338.511.

CE requirements do not apply for student pharmacists or interns. It is not clear whether the human

trafficking training is required.

Rules Committee (1)(a) and (2)(a): The Rules Committee agrees with the comment to replace “90 days” with “180 days.”

Response

(3)(4): The Rules Committee agrees with the comments that the rules should be clarified to indicate that a licensee may

engage in the practice of pharmacy only under the personal charge of a pharmacist. However, if the licensee wants to

count the hours towards the required internship they must also be acting under a preceptor. The Rules Committee does

not agree with the proposed language in either comment to (3) or (4) above.

(6): The Rules Committee agrees with the comment to add the requirement of the human trafficking training.

R 338.513 Educational limited license; application and renewal; practices.

Rule 13. (1) An applicant for an educational limited license shall submit to the department a completed application on a form

provided by the department with the requisite fee. In addition to satisfying the requirements of sections 16174 and 17737 of

the code, MCL 333.16174 and MCL 333.17737, the applicant shall establish either of the following:

(a) That he or she is actively enrolled in, or is within 180 days of having graduated from, an approved educational program.

(b) That he or she has successfully passed the foreign pharmacy graduate equivalency examination administered by the

national association of boards of pharmacy (NABP) Foreign Pharmacy Graduate Examination Committee, 1600 Feehanville

Dr., Mount Prospect, IL 60056, https://nabp.pharmacy/programs/fpgec/ .

(2) The educational limited license must be renewed annually.

(a) At the time of renewal, the applicant shall submit verification to the department that he or she is actively enrolled in, or is

within 180 days of having graduated from, an approved educational program. The educational limited license is valid for 1

year.

11

(b) If an applicant is a graduate of a non-accredited college or school of pharmacy at the time of renewal, the applicant shall

submit verification to the department from his or her preceptor that the applicant is currently in an internship program under

the preceptor’s supervision. The educational limited license is valid for 1 year and may be renewed 1 time.

(3) An educational limited licensee may engage in the practice of pharmacy only under the personal charge of a pharmacist.

(4) An educational limited licensee shall verify that his or her pharmacy preceptor holds a valid preceptor license prior to

engaging in the practice of pharmacy if the internship hours will be submitted to the department for credit.

(5) An educational limited licensee shall notify the board within 30 days if he or she is no longer actively enrolled in an

approved educational program.

(6) An applicant for an educational limited license shall meet the requirements of R 338.511.

Board Response

(1)(a) and (2)(a): The Board agrees with the comment to replace “90 days” with “180 days.”

(3)(4): The Board agrees with the comments that the rules should be clarified to indicate that a licensee may

engage in the practice of pharmacy only under the personal charge of a pharmacist. However, if the licensee

wants to count the hours towards the required internship they must also be acting under a preceptor. The Board

does not agree with the proposed language in either comment to (3) or (4) above.

(6): The Board agrees with the comment to add the requirement of the human trafficking training.

Rule 338.515

Rule Numbers

Section (c)

Internship requirements.

Commenter

Comment

Carlson/MHA

In the section for “Internship requirements,” we trust the Board will carefully review and consider

who it will allow to verify hours. We understand allowing more than a licensed pharmacy preceptor

or approved education program for future flexibility but currently, the MHA does not see a category

of “others” who are qualified to do this.

Sapita/MPA

Remove “or other person previously approved by the board.”

Remove “personal charge” replace with “supervision of.”

Section (3)

Rules Committee The Rules Committee does not agree to delete the reference to “other person” and the comment is withdrawn. As a

Response change is being made to R 338.513 the comment to (3) is withdrawn.

12

R 338.515 Internship requirements.

Rule 15. (1) An internship must be a minimum of 1,600 hours.

(a) Not more than 40 hours per week may be earned.

(b) An unconventional internship requires prior board approval and is limited to a maximum of 400 hours, with a maximum

of 16 hours earned per week, and not more than 40 hours earned per week when the intern’s pharmacy school is not in

session. “Unconventional internship” means an educational program of professional and practical experience involving the

pharmacy or related pharmaceutical experiences which, through on-the-job training, provides knowledge useful to the

practice of the profession of pharmacy.

(c) The preceptor, an approved education program, or other person previously approved by the board shall verify the hours.

(2) The internship must provide professional and practical experience.

(3) If an internship is not completed through an approved educational program or under the personal charge of a preceptor,

the individual shall petition the board for approval of hours.

(4) An individual shall obtain an educational limited license pursuant to R 338.513 before starting an internship that includes

the practice of pharmacy in this state.

Board Response

The Board did not evaluate the comments to this rule as both comments were withdrawn.

Rule 338.519

Rule Numbers

Section (4)

Examinations adoption; passing scores; reexamination.

Commenter

Sapita/MPA

Baran/Ferris

Comment

After “examinations” add “within 3 attempts” after “after” add “the third.”

Section (4) – (6)

Modify (4). This section should be deleted as even the NABP allow for 5 attempts before any

remediation is needed. This would be very costly and increase the pressure on passing this exam.

No other health profession has this strict requirement. Also, none of the Great Lakes States have

this strict requirement. One allows 2 failures, 2 allow 3 failures and the others follow the NABP.

Suggest adding back language that would allow 5 attempts, suggested language: (4) An applicant

who has not received a passing score on the NAPLEX and or MPJE examinations after 5 attempts

shall provide certification from an approved education program certifying that he or she

satisfactorily completed courses that provide a thorough review of the area or areas that he or she

failed in the most recent examination.

To be able to mandate this NABP has to provide to the applicant the areas they failed in, which I

13

believe is not done currently.

Add to Section (4) Daman/Ferris

Modify after (4) as follows:

(5) An applicant who has not received a passing score on an examination that measures his or her

theoretical and practical knowledge of pharmacy after 5 attempts shall not take the examination a

sixth or subsequent time, unless the applicant can demonstrate to the board that he or she has

complied with all of the following:

(a) Enrolled as a student in a pharmacy education program approved by the board.

(b) Taken courses which would provide a thorough review of those areas failed on the applicant's

most recent examination.

(c) Submitted certification to the board from the pharmacy education institution that the courses

have been satisfactorily completed.

(6) An applicant who fails to pass the NAPLEX shall wait at least 45 days to retest or comply with

the current waiting period established by NABP, whichever is later. An applicant who has not

achieved a passing score on the NAPLEX shall not take the NAPLEX more than 2 times in a 12-

month period.

(7) An applicant who fails to pass the MPJE shall wait at least 30 days to retest or comply with the

current waiting period established by NABP, whichever is later.

(8) An applicant shall not sit for either exam specified in subrule (5) or (6) of this rule more than 5

times, unless he or she successfully repeats an approved education program, as specified in R

338.521(2)(a)(i), or successfully repeats the foreign pharmacy graduate equivalency examination

committee certification program administered by the NABP, and provides proof of completion to

the board.

Section (4)

Carlson/MHA

Under the “Practice of Pharmacy” Section, the new North American Pharmacist Licensure

Examination (NAPLEX) and Michigan Multistate Pharmacy Jurisprudence Examination (MPJE)

passing requirements raised some apprehension among hospital membership. While we respect the

proposal to safeguard competent pharmacists to enter the workforce, the MHA wants to ensure

qualified candidates are not inadvertently vetted out. Other variables, including education, prior

employment, internships, residencies and skills which are valuable to hospitals are not defined by

exams alone. Additionally, one day of poor performance during a test can happen, and students

deserve another try before they are required to provide satisfactorily completed courses information

to the Board.

14

Modify to:

(4) If an applicant for licensure fails to pass either of these examinations within 3 attempts, he or

she shall provide the board, after the third failed attempt and prior to retesting, certification from

an approved education program certifying that he or she satisfactorily completed courses that

provide a thorough review of the area or areas that he or she failed in the most recent examination.

This is more reasonable than after each failed exam and also aligns with the “3exam 12-month” cap

outlined in (5).

Section (4)

Eid/Ferris and

Osborne/Ferris

Keep as written in R 338.474a (1-3) or remove (4) in the proposed rule. National pass rates in 2018

for NAPLEX were 89.4% for first time attempts and the Michigan rate was 92.59% and the

National pass rates for the MPJE for 2018 were 83.76% for first time attempts and the Michigan

rate was 92%. This change seems unnecessary. This potentially places a financial burden on a

sizable portion of student pharmacists. Ohio, Indiana does not have this requirement and Illinois

allows for three attempts before requiring remedial education. There is no sound evident that adding

this educational requirement after each failure will improve passing rates.

Osborne suggested this language:

R 338.519 Examinations adoption; passing scores; reexamination.

Rule 19. (1) The board adopts the North American pharmacist licensure examination (NAPLEX)

developed and administered by the NABP.

(2) The board adopts the Michigan multistate pharmacy jurisprudence examination (MPJE) that is

developed and administered by NABP.

(3) The passing score for the NAPLEX or the MPJE accepted for licensure will be the passing score

established by the NABP.

(4) If an applicant for licensure fails to pass either of these examinations, he or she shall provide the

board, after each failed attempt and prior to retesting, certification from an approved education

program certifying that he or she satisfactorily completed courses that provide a thorough review of

the area or areas that he or she failed in the most recent examination.

(4) An applicant who has not received a passing score on an examination that measures his or

her theoretical and practical knowledge of pharmacy after 5 attempts shall not take the

15

examination a sixth or subsequent time, unless the applicant can demonstrate to the board

that he or she has complied with all of the following:

(a) Enrolled as a student in a pharmacy education program approved by the board.

(b) Taken courses which would provide a thorough review of those areas failed on the

applicant's most recent examination.

(c) Submitted certification to the board from the pharmacy education institution that the

courses have been satisfactorily completed.

(5) An applicant who fails to pass the NAPLEX shall wait at least 45 days to retest or comply with

the current waiting period established by NABP, whichever is later. An applicant who has not

achieved a passing score on the NAPLEX shall not take the NAPLEX more than 3 times in a 12-

month period.

(6) An applicant who fails to pass the MPJE shall wait at least 30 days to retest or comply with the

current waiting period established by NABP, whichever is later.

(7) An applicant shall not sit for either exam specified in subrule (5) or (6) of this rule more than 5

times, unless he or she successfully repeats an approved education program, as specified in R

338.521(2)(a)(i), or successfully repeats the foreign pharmacy graduate equivalency examination

committee certification program administered by the NABP, and provides proof of completion to

the board.

Section (7)

Baran/Ferris

This section as currently written would require the applicant to completely redo the pharmacy

degree and not just the sections they failed. Yet a foreign graduate would not have to do so.

Rules Committee The Rules Committee agrees with the comment to:

Response

• Modify (4) to “within 3 attempts” not 1 attempt.

• Modify (7) to require an applicant to take a pharmacy law course in an educational program or redo the program

depending on which examination they have failed 5 times.

• Delete the reference to the foreign pharmacy graduate equivalency examination certification program as a foreign

graduate should be held to the same standard if they are failing the examinations.

The Rules Committee disagree with the other comments as too restrictive.

R 338.519 Examinations adoption; passing scores; reexamination.

16

Rule 19. (1) The board adopts the North American pharmacist licensure examination (NAPLEX) developed and

administered by the NABP.

(2) The board adopts the Michigan multistate pharmacy jurisprudence examination (MPJE) that is developed and

administered by NABP.

(3) The passing score for the NAPLEX or the MPJE accepted for licensure will be the passing score established by the NABP.

(4) If an applicant for licensure fails to pass either of these examinations, within 3 attempts, he or she shall provide the board,

after each failed the third attempt and prior to retesting, certification from an approved education program certifying that he

or she satisfactorily completed courses that provide a thorough review of the area or areas that he or she failed in the most

recent examination.

(5) An applicant who fails to pass the NAPLEX shall wait at least 45 days to retest or comply with the current waiting period

established by NABP, whichever is later. An applicant who has not achieved a passing score on the NAPLEX shall not take the

NAPLEX more than 3 times in a 12-month period.

(6) An applicant who fails to pass the MPJE shall wait at least 30 days to retest or comply with the current waiting period

established by NABP, whichever is later.

(7) An applicant shall not sit for either the NAPLEX exam specified in subrule (5) or (6) of this rule more than 5 times, unless

he or she successfully repeats an approved education program, as specified in R 338.521(2)(a)(i), or successfully repeats the

foreign pharmacy graduate equivalency examination committee certification program administered by the NABP, and

provides proof of completion to the board.

(8) An applicant shall not sit for the MPJE specified in subrule (6) of this rule more than 5 times, unless he or she successfully

repeats an approved pharmacy law course in an educational program, as specified in R 338.521(2)(a)(i), and provides proof of

completion to the board.

Board Response

The Board agrees with the comments to:

• Modify (4) to “within 3 attempts” not 1 attempt.

• Modify (7) and add (8) to require an applicant to take a pharmacy law course in an educational program

or redo the program depending on which examination they have failed 5 times.

• Delete the reference to the foreign pharmacy graduate equivalency examination certification program as

a foreign graduate should be held to the same standard if they are failing the examinations.

The Board does not agree with the other comments as they are too restrictive.

Rule 338.521

Pharmacist licensure by examination.

17

Rule Numbers

Section (2)(i)

Commenter

Carlson/MHA

Comment

Under the “Pharmacist licensure by examination” section, it is important to note that Canadian

Council for Accreditation of Pharmacy Programs uses different criteria than the Accreditation

Council for Pharmacy Education.

Modify to:

A professional degree from a school of pharmacy accredited by the Accreditation Council

for Pharmacy Education or the Canadian council for accreditation of pharmacy programs.

Sapita/MPA

Remove “Canadian council for accreditation of pharmacy programs.” The Canadian

Healthcare System is significantly different than that of the United States and should be

removed from the rules.

Rules Committee (2)(i): The Rules Committee agrees with the comment to delete the reference to the Canadian Council for

Response Accreditation of Pharmacy Programs as it is not equivalent to ACPE.

R 338.521 Pharmacist licensure by examination.

Rule 21. (1) An applicant for licensure as a pharmacist by examination shall submit to the department a completed

application on a form provided by the department with the requisite fee.

(2) In addition to meeting the requirements of section 16174 of the code, MCL 333.16174, an applicant for licensure shall

satisfy all of the following requirements:

(a) Earned either of the following:

(i) A professional degree from a school of pharmacy accredited by the American council of pharmaceutical education or the

Canadian council for accreditation of pharmacy programs.

(ii) A foreign pharmacy graduate examination committee certificate administered by the NABP.

(b) Successfully passed the MPJE and the NAPLEX.

(c) Completed an internship as set forth in R 338.515.

(3) An applicant’s license shall be verified by the licensing agency of any state of the United States in which the applicant

holds or has ever held a license to practice pharmacy. This includes, but is not limited to, showing proof of any disciplinary

action taken or pending against the applicant.

Board Response

(2)(i): The Board agrees with the comment to delete the reference to the Canadian Council for Accreditation of

18

Pharmacy Programs as it is not equivalent to ACPE.

Rule 338.523

Rule Numbers

(2)(a)

Pharmacist license by endorsement; requirements.

Commenter

Comment

Watson/NABP

Mirror the license by exam rules to require the Foreign Pharmacy Graduate Examination

Committee^TM(FPGEC^®) under the License by Endorsement as follows:

That he or she has successfully passed the foreign pharmacy graduate equivalency examination

administered by the national association of boards of pharmacy (NABP) Foreign Pharmacy

Graduate Examination Committee, 1600 Feehanville Dr., Mount Prospect, IL 60056,

https://nabp.pharmacy/programs/fpgec/ .

AND:

A foreign pharmacy graduate examination committee certificate administered by the NABP.

Rules Committee (2)(a): The Rules Committee agrees with the suggested change to require passing the examination and meet the FPGEC

Response requirements.

R 338.523 Pharmacist license by endorsement; requirements.

Rule 23. (1) An applicant for licensure as a pharmacist by endorsement shall submit to the department a completed

application on a form provided by the department with the requisite fee. An applicant who meets the requirements of this rule

is presumed to meet the requirements of section 16186 of the code, MCL 333.16186.

(2) An applicant shall satisfy all of the following requirements:

(a) Establish that the he or she is currently licensed in another state and was initially licensed by examination in another state

or he or she successfully passed the foreign pharmacy graduate examination administered by NABP and he or she has

obtained a foreign pharmacy graduate examination committee certificate administered by the NABP.

(b) Pass the MPJE as required under R 338.519.

(c) Have his or her license verified by the licensing agency of any state of the United States in which the applicant holds or has

ever held a license to practice pharmacy. This includes, but is not limited to, showing proof of any disciplinary action taken or

pending against the applicant.

(d) Submit the MPJE examination score report and NABP licensure transfer report to the department.

Board Response

(2)(a): The Board agrees with the suggested change to require passing the examination and obtaining the FPGEC

19

certificate from NABP.

Rule 338.525

Relicensure of a pharmacist license; requirements.

Rule Numbers

Section (1) and (2) Eid/Ferris

Commenter

Comment

Questions what happens to applications when the new CE requirements become effective and

shouldn’t the one-time trainings be required for relicensure?

Remove “or outside of Michigan.”

Section (1)(f) and

(g)

Sapita/MPA

Rules Committee The Rules Committee agrees with the comment to clarify that relicensure will not be granted until the continuing

Response

education requirements are met, and that to meet relicensure an applicant must meet the one-time training requirements.

(1)(f) and (g): The comment to remove “ or outside of Michigan” is withdrawn.

R 338.525 Relicensure of a pharmacist license; requirements.

Rule 25. (1) An applicant for relicensure whose pharmacist license has lapsed, under the provisions of sections 16201(3) or

(4), and 17733 of the code, MCL 333.16201(3), MCL 333.16201(4), and MCL 333.17733, as applicable, may be relicensed by

complying with the following requirements as noted by (x):

(1) For a pharmacist who has let his

or her license lapse and who is not

currently licensed in another state:

License lapsed 0- License lapsed

License lapsed 8

or more years

3 years

X

more than 3

years, but less

than 8 years

X

(a) Application and fee: submit to the

department a completed application

on a form provided by the

department, with the requisite fee.

(b) Good moral character: establish

that he or she is of good moral

character as defined under sections 1

to 7 of 1974 PA 381, MCL 338.41 to

MCL 338.47.

X

20

(c) Submit fingerprints: submit

fingerprints as required under section

16174(3) of the code, MCL

X

333.16174(3).

(d) Continuing education: submit

proof of having completed 30 hours of

continuing education that satisfy R

338.3041 to R 338.3045 in the 2 years

immediately preceding the date of

application for relicensure. However,

if the continuing education hours

submitted with the application are

deficient, the applicant has 2 years

from the date of the application to

complete the deficient hours. The

application will be held and the license

will not be issued until the continuing

education requirements have been

met.

X

(e) Submit proof of having completed

both a 1-time training in identifying

victims of human trafficking as

required in R 338.511 and a 1-time

training in opioids and other

X

controlled substances awareness as

required in R 338.3135.

(f) Pass MPJE: retake and pass the

MPJE as provided in R 338.519.

(g) Practical experience: complete 200

hours of practical experience under

the personal charge of a currently

X

21

licensed Michigan pharmacist in or

outside of Michigan, within 6 months

of applying for relicensure.

(h) Practical experience: complete 400

hours of practical experience under

the personal charge of a currently

licensed Michigan pharmacist in or

outside of Michigan, within 6 months

of applying for relicensure.

X

(i) Examination: pass the NAPLEX

within 2 years before applying for

relicensure, as provided in R 338.519.

(j) Verification: submit verification

from the licensing agency of all other

states of the United States in which

the applicant has ever held a license to

practice pharmacy. Verification must

include the record of any disciplinary

action taken or pending against the

applicant.

X

(2) For purposes of subrule (1)(g) and (h) of this rule, an applicant may be granted a nonrenewable limited license to

complete the practical experience.

(3) To demonstrate compliance with subrule (1)(g) or (h), the supervising pharmacist shall provide verification to the

department of the applicant’s completion of the experience on a form provided by the department.

(4) For a pharmacist who has let his or her

pharmacist license lapse, but who holds a

current and valid pharmacist license in

another state:

License lapsed

more than 3

years, but less more years

than 8 years

License

lapsed 0-3

Years

License lapsed 8 or

(a) Application and fee: submit to the

X

22

department a completed application on a form

provided by the department, with the

requisite fee.

(b) Good moral character: establish that he or

she is of good moral character as defined

under sections 1 to 7 of 1974 PA 381, MCL

338.41 to MCL 338.47.

(c) Submit fingerprints: submit fingerprints

as required under section 16174(3) of the

code, MCL 333.16174(3).

X

(d) Continuing education: submit proof of

having completed 30 hours of continuing

education that satisfy R 338.3041 to R

338.3045 in the 2 years immediately preceding

the date of application for relicensure.

However, if the continuing education hours

submitted with the application are deficient,

the applicant has 2 years from the date of the

application to complete the deficient hours.

The application will be held and the license

will not be issued until the continuing

X

education requirements have been met.

(e) Submit proof of having completed both a

1-time training in identifying victims of

human trafficking as required in R 338.511

and a 1-time training in opioids and other

controlled substances awareness as required

in R 338.3135.

X

(f) Examination: retake and pass the MPJE as

provided in R 338.519.

X

23

(g) Verification: submit verification from the

licensing agency of all other states of the

United States in which the applicant holds or

has ever held a license to practice pharmacy.

Verification must include the record of any

disciplinary action taken or pending against

the applicant.

X

Board Response

The Board agrees with the comment to clarify that relicensure will not be granted until the continuing education

requirements are met, and that to meet relicensure an applicant must meet the one-time training requirements.

(1)(f) and (g): The comment to remove “ or outside of Michigan” is withdrawn.

Rule 338.531

Rule Numbers

Section (3)

Pharmacy license; applications; requirements.

Commenter

Baran/Ferris

Comment

This should be modified to: (3) The department shall issue only 1 pharmacy license per address. If

an applicant has more than 1 location at which drugs are prepared, or dispensed, or prescriptions

received, each address location shall obtain a separate license.

This is to align with MCL 333.17722 and also require any location where prescriptions are dropped

off for filling would need to be licensed.

Sapita/MPA

Baran/Ferris

MPA recommends the language mirrors R 338.477 “If multiple locations under the same

ownership exist at a single street address and share a central inventory, then only 1 license is

required.”

Section (4)

Add USP Chapter 797 to make it consistent with Rule 338.533(1).

Kuhns/Portage

Pharmacy

Roath/SpartanNash

Delete “and 800”.

The adoption of these reference standards in conjunction with the clause in (4)(b) seems to imply

that the standards are only applicable to pharmacies providing compounding services, though this

is not explicit. Additionally, some of the guidance in the standards extend to practices beyond

24

compounding and it is unclear as to whether pharmacies operating under the purview of these

standards would be required to comply with the full reference standard, or just the areas that

apply to compounding practices. Additionally, recent comments at the NABP Annual meeting by

a USP representative suggest that the USP’s intent regarding general chapter 800 indicate that

this guidance was intended to apply to compounding activities only. To provide additional

clarification, we recommend that Rule 31, Subrule (4)(b) be modified to read: “A pharmacy that

provides compounding services shall comply with all standards adopted in subrule (4) of this rule

as they apply to compounding services as defined in Michigan law.”

Section (4)

Sullivan/Michigan Requests not adopting USP 797 and 800 and urges the Board to consider having MIOSHA adopt

Surgical Hospital

USP 800 as an occupational health standard so it can be equally applied to all professions.

Rules Committee (3): The Rules Committee does not agree with modifying the language in (3) and more discussion is needed.

Response

(4): The Rules Committee members are split regarding the comment to delete USP 800 from the rule until it is published

in the compendium. The Rules Committee does not agree with modifying the rules to clarify that USP 800 applies to

pharmacies that do not handle compounding or other entities such as offices and clinics. As the Board does not have

authority over MIOSHA it may not require it to adopt USP 800.

R 338.531 Pharmacy license; applications; requirements.

Rule 31. (1) An applicant for a pharmacy license shall submit to the department a completed application on a form provided

by the department together with the requisite fee.

(2) An applicant shall submit all of the following information:

(a) Certified copies of articles of incorporation or partnership certificates and certified copies of assumed name certificates, if

applicable.

(b) Submission of fingerprints for the purpose of a criminal history background check required under section 17748(6) of the

code, MCL 333.17748(6).

(c) Proof of registration or licensure from every state or province where the pharmacy is currently licensed or has ever held a

license or registration.

(d) The name and license number of the pharmacist in this state designated as the pharmacist in charge (PIC) pursuant to

section 17748(2) of the code, MCL 333.17748(2), who must have a valid and unrestricted license.

(e) The identity and address of each partner, officer, or owner, as applicable.

(f) A completed self-inspection form.

25

(g) If the applicant intends to provide sterile compounding services, proof of application with an entity that satisfies the

requirements of R 338.532.

(h) An inspection report that satisfies the requirements of R 338.534.

(i) If the applicant is an in-state pharmacy that intends to compound sterile pharmaceutical products, the applicant shall

submit to an inspection from an approved accrediting organization under R 338.532.

(j) If the applicant is a governmental entity, an individual must be designated as the licensee. The licensee and the pharmacist

on duty shall be responsible for complying with all federal and state laws regulating the practice of pharmacy and the

dispensing of prescription drugs.

(3) The department shall issue only 1 pharmacy license per address. If an applicant has more than 1 location at which drugs

are prepared or dispensed, each address location shall obtain a separate license.

(4) The board approves and adopts by reference the compounding standards of the United States Pharmacopeia (USP),

published by the United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, MD 20852-1790. This

includes, but is not limited to, USP Chapters 795 and 797 and 800.

(a) The standards adopted by reference in subrule (4) of this rule are available at cost at http://www.usp.org/compounding , or

at cost from the Board of Pharmacy, Bureau of Professional Licensing, Michigan Department of Licensing and Regulatory

Affairs, Ottawa Building, 611 West Ottawa, P.O. Box 30670, Lansing, MI 48909.

(b) A pharmacy that provides compounding services shall comply with all standards adopted in subrule (4) of this rule.

Board Response

(3): The Board does not agree with the suggested comments as it believes the current language is appropriate.

(4): The Board agrees with the comments to delete USP 800 from the rule until it is published in the

compendium. The Board agrees with adding USP 797 for consistency.

The Board does not agree with modifying the rules to clarify that USP 800 applies to pharmacies that do not

handle compounding or other entities such as offices and clinics, although this comment is moot at this time as

the Board is not recommending adoption until it is published in the compendium.

(2)(g) and (i): As the Board agrees with the comments to R 338.532 and R 338.533 to delete the term “sterile” as

the rules should regulate sterile and non-sterile compounding, for consistency, “sterile” will also be deleted from

R 338.531.

Rule 338.532

Sterile compounding accrediting organizations; board approval; inspection entities.

Rule Numbers

Commenter

Comment

26

Section (1)

Kuhns/Portage

Pharmacy

Modify as follows:

(1) The board shall approve, under section 17748a of the code, MCL 333.17748a,

accrediting or inspection organizations or inspection entities for pharmacies entities that

compound sterile pharmaceuticals according to standards adopted by reference in R

338.533.

Add: (1)(a)“Entities” means pharmacies, physician private offices, dental private offices,

podiatric private offices, veterinarian private offices, infusion centers, surgical outpatient

facilities, hospitals, health facilities, and outsourcing facilities.

Section (3)

Eid/Ferris

How often must an inspection be submitted? Are the details of the inspection required to be shared

with the state?

Rules Committee (1): The Rules Committee does not agree with broadening the requirement of an inspection under MCL 333.17748a to

Response

more than pharmacies as this would require a change to the Public Health Code. The Rules Committee agrees with the

comment to delete the term “sterile” from R 338.532 and R 338.533, as both rules should regulate sterile and non-sterile

compounding.

(3): The Rules Committee agrees with the comment that the results of pharmacy inspections should be required to be

shared with the Department but does not agree that the rule should include a set expiration date of a certain amount of

years for accreditation approvals. The inspection entity should submit the length of their accreditation approvals with

their application as an approval entity.

R 338.532 Sterile compounding Compounding accrediting organizations; board approval; inspection entities.

Rule 32. (1) The board shall approve, under section 17748a of the code, MCL 333.17748a, accrediting organizations or

inspection entities for pharmacies that compound sterile pharmaceuticals according to standards adopted by reference in R

338.533.

(2) The department shall post on its website, the list of organizations approved under subrule (1) of this rule.

(3) An organization may petition the board for approval under subrule (1) of this rule. The petition must include, but not be

limited to, all of the following:

(a) Requirements for accreditation or compliance.

(b) Requirements for inspectors.

(c) Training provided to inspectors.

(d) Copy of the most current inspection form.

27

(e) The length of accreditation.

(f) Agreement and plan to share results of inspections with the Department.

(4) If the board approves the petition, the approval is valid for 3 years from the date of approval. The organization may

submit a petition that complies with subrule (3) of this rule to seek continuing approval.

(5) The board may rescind approval of an organization upon just cause. The rescission will not immediately affect the

compliance of a pharmacy using the accreditation. Within 12 months of the rescission date or by the next licensure renewal

date, whichever is later, the accreditation is void, and a pharmacy shall obtain accreditation or an inspection from an

organization that satisfies subrule (1) of this rule.

Board Response

(1): The Board does not agree with broadening the requirement of an inspection under MCL 333.17748a to more

than pharmacies as this would require a change to the Public Health Code. The Board agrees with the comment

to delete the term “sterile” from R 338.532 and R 338.533, as both rules should regulate sterile and non-sterile

compounding. For consistency “sterile” will also be deleted from R 338.531.

(3): The Board agrees with the comment that the results of pharmacy inspections should be required to be shared

with the Department and does not agree that the rule should include a set expiration date of a certain amount of

years for accreditation approvals. The inspection entity should submit the length of their accreditation approvals

with their application as an approval entity.

Rule 338.533

Rule Numbers

Section (1)

Sterile compounding standards and requirements; outsourcing facilities; requirements.

Commenter

Popyk/Health

Dimensions

Comment

Delete adoption of

USP 795, 797, and 800.

Modify as follows:

Section (1) – (10)

Kuhns/Portage

Pharmacy

R 338.533 Sterile Compounding standards and requirements; outsourcing facilities;

requirements.

Rule 33. (1) The board approves and adopts by reference the compounding standards of

the United States Pharmacopeia (USP) Chapters 795 and 797., published by the United

States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, MD 20852-

1790. This includes, but is not limited to, USP Chapters 795, 797, and 800.

28

(2) The board approves and adopts by reference the compounding standards of the

United States Pharmacopeia (USP) Chapter 800 for entities engaged in

compounding, preparing, or otherwise manipulating antineoplastic drugs.

(a) “Entities” means pharmacies, physician private offices, dental private offices,

podiatric private offices, veterinarian private offices, infusion centers, surgical

outpatient facilities, hospitals, health facilities, and outsourcing facilities.

(b) “Antineoplastic drugs” means substances identified as antineoplastic drugs by the

National Institute of Occupational Safety and Health (NIOSH).

(3) The standards adopted by reference in subrule (1) and (2) of this rule are available at

cost at http://www.usp.org/compounding, or at cost from the Board of Pharmacy, Bureau

of Professional Licensing, Michigan Department of Licensing and Regulatory Affairs,

Ottawa Building, 611 West Ottawa, P.O. Box 30670, Lansing, MI 48909.

(4) A pharmacy, physician private office, dental private office, podiatric private office,

veterinarian private office, infusion center, surgical outpatient facility, hospital, health

facility, or outsourcing facility that provides sterile compounding services shall comply

with all current standards adopted in subrule (1) and (2) of this rule.

(5) An outsourcing facility located in this state or that dispenses, provides,

distributes, or otherwise furnishes sterile compounded pharmaceuticals in this

state must shall be inspected and registered asan

outsourcing facility by the United States Food and Drug Administration (FDA) prior to

applying for a pharmacy license in this state.

(6) An outsourcing facility must undergo an inspection by the board, or a third party

recognized by the board if the outsourcing facility is registered with the FDA but has

not received an FDA inspection as an outsourcing facility. Third party inspection

providers approved by the board must be posted on the department’s website.

(7) A licensed outsourcing facility shall submit to the board a copy of the biannual

report it provided to the FDA that identifies the drugs compounded in the previous 6-

month period, including a drug’s active ingredients, strength, and dosage form.

(8) An outsourcing facility shall do all of the following:

(a) Compound drugs by or under the supervision of a licensed pharmacist.

(b) Compound drugs pursuant to current good manufacturing practices for finished

29

pharmaceuticals set forth in 21 C.F.R. sections 211.1 to 211.208 (1978).

(c) Ensure that a pharmacist or pharmacists who conducts or oversees sterile

compounding at an outsourcing facility is proficient in the practice of sterile

compounding and has acquired the education, training, and experience to maintain that

proficiency by doing any of the following:

(i) Participating in seminars.

(ii) Studying appropriate literature.

(iii) Consulting with colleagues.

(iv) Being certified by a compounding certification program approved by the board.

(d) Label compounded drugs with all of the following:

(i) Required drug and ingredient information.

(ii) Facility identification.

(iii) The following or similar statement: “This is a compounded drug. For office use

only” or “Not for resale.”

(e) Ensure that bulk drug substances used for sterile compounding meet specified

FDA criteria.

(9) An outsourcing facility may compound drugs that appear on an FDA shortage list, if

the bulk drug substances used to compound the drugs comply with the criteria specified in

this rule.

(10) An outsourcing facility may compound drugs using bulk drug substances that

appear on a list established by the Secretary identifying bulk drug substances for which

there is a clinical need.

)

The term “Secretary" means the Secretary of Health and Human Services of the

United States.

Section (7)(c)(iv)

Clark/bps

Bps encourages the BOP to recognize bps Board Certification in Compounded Sterile Preparations

as meeting the standards in (c)(iv) as “ a compounding certification program approved by the

board.”

Section (7)(d)(i),

(ii), and (iii)

Baran/Ferris

Modify to:

“(d) label compounded drugs in compliance with the Federal Food, Drug, and Cosmetic Act

503B(10) and rule 338.582.”

30

The label must include the requirements of both the state and federal law.

This would be easier to quote the federal law at (7)(d) instead of listing all of the following.

“`(10) Labeling of drugs.--

``(A) Label.--The label of the drug includes--

``(i) the statement `This is a compounded drug.' or a

reasonable comparable alternative statement (as specified

by the Secretary) that prominently identifies the drug as a

compounded drug;

``(ii) the name, address, and phone number of the

applicable outsourcing facility; and

``(iii) with respect to the drug--

``(I) the lot or batch number;

``(II) the established name of the drug;

``(III) the dosage form and strength;

``(IV) the statement of quantity or volume, as

appropriate;

``(V) the date that the drug was compounded;

``(VI) the expiration date;

``(VII) storage and handling instructions;

``(VIII) the National Drug Code number, if

available;

``(IX) the statement `Not for resale', and, if the

drug is dispensed or distributed other than pursuant to

a prescription for an individual identified patient,

the statement `Office Use Only'; and

``(X) subject to subparagraph (B)(i), a list of

active and inactive ingredients, identified by

established name and the quantity or proportion of each

ingredient.”

31

Also, the label needs to meet the requirements in Rule 338.582, and it would be easier to state the

rule number and not all the details in the rule.

Section (7)(a)

Carlson/MHA

“Supervision” is not defined in the Code or the rules. The Code and rules generally use “personal

charge” in reference to needing the immediate presence of a pharmacist.

Modify supervision to personal charge.

Rules Committee (1): The Rules Committee members are split regarding whether to delete references to USP chapters in the rules as USP

Response

is adopted in the Code or to specifically refer to USP chapters 795, 797, and 825, and if the rules should reference the

specific date of the published compendium. The consensus is to continue discussion with the full Board. The Rules

Committee suggested referencing the statutory requirement of complying with USP instead of listing each chapter.

(1) to (10): The Rules Committee agrees with the comment to delete the term “sterile” from R 338.532 and R 338.533, as

both rules should regulate sterile and non-sterile compounding.

(4): The Rules Committee does not agree with modifying the rules to clarify that USP applies to entities other than

pharmacies, including private physician offices, dental offices, podiatric offices, veterinarian offices, infusion centers,

surgical outpatient facilities, hospitals, and health facilities. The Rules Committee agrees with further expanding the term

“distributes” to “dispenses, provides, distributes, or otherwise furnishes.”

(5): The Rules Committee is split on whether to limit inspections to the FDA for outsourcing facilities that deal with

compounded pharmaceuticals in Michigan.

(7)(a): The Rules Committee does not agree with changing supervision to personal charge. The pharmacist must be on

site.

7(c)(iv): The Rules Committee does not agree with listing the entities that provide accreditation in the rules because

adding entities or taking them off of the list would require modifying the rules.

7(d)(i), (ii), and (iii): The Rules Committee recommends adding the proposed language for clarity, and also reference R

338.582 for patient specific drugs.

(10): The Rules Committee agrees with adding the language to (10) if the language is consistent with Federal law and is

not already in the definition.

R 338.533 Sterile compounding Compounding standards and requirements; outsourcing facilities; requirements.

32

Rule 33. (1) The board approves and adopts by reference the compounding standards of the United States Pharmacopeia

(USP), published by the United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, MD 20852-1790.

This includes, but is not limited to, USP Chapters 795 and 797.

(2) The standards adopted by reference in subrule (1) of this rule are available at cost at http://www.usp.org/compounding , or

at cost from the Board of Pharmacy, Bureau of Professional Licensing, Michigan Department of Licensing and Regulatory

Affairs, Ottawa Building, 611 West Ottawa, P.O. Box 30670, Lansing, MI 48909.

(3) A pharmacy that provides sterile compounding services shall comply with all current standards adopted in subrule (1) of

this rule.

(4) An outsourcing facility located in this state or that dispenses, provides, distributes, or otherwise furnishes sterile

compounded pharmaceuticals in this state shall be inspected and registered as an outsourcing facility by the United States

Food and Drug Administration (FDA) prior to applying for a pharmacy license in this state.

(5) An outsourcing facility must undergo an inspection by the board or a third party recognized by the board if the

outsourcing facility is registered with the FDA but has not received an FDA inspection as an outsourcing facility. Third party

inspection providers approved by the board must be posted on the department’s website.

(5) A licensed outsourcing facility shall submit to the board a copy of the biannual report it provided to the FDA that

identifies the drugs compounded in the previous 6-month period, including a drug’s active ingredients, strength, and dosage

form.

(6) An outsourcing facility shall do all of the following:

(a) Compound drugs by or under the supervision of a licensed pharmacist.

(b) Compound drugs pursuant to current good manufacturing practices for finished pharmaceuticals set forth in 21 C.F.R.

sections 211.1 to 211.208 (1978).

(c) Ensure that a pharmacist or pharmacists who conducts or oversees sterile compounding at an outsourcing facility is

proficient in the practice of sterile compounding and has acquired the education, training, and experience to maintain that

proficiency by doing any of the following:

(i) Participating in seminars.

(ii) Studying appropriate literature.

(iii) Consulting with colleagues.

(iv) Being certified by a compounding certification program approved by the board.

(d) Label compounded drugs with all of the following and label compounded drugs that are patient specific with all of the

following and consistent with the requirements in R 338.582:

(i) Required drug and ingredient information.

33

(ii) Facility identification.

(iii) The following or similar statement: “This is a compounded drug. For office use only” or “Not for resale.”

(e) Ensure that bulk drug substances used for sterile compounding meet specified FDA criteria.

(7) An outsourcing facility may compound drugs that appear on an FDA shortage list, if the bulk drug substances used to

compound the drugs comply with the criteria specified in this rule.

(8) An outsourcing facility may compound drugs using bulk drug substances that appear on a list established by the United

States Secretary of Health and Human Services identifying bulk drug substances for which there is a clinical need.

Board Response

(1): The Board does not agree with the comment to delete references to USP chapters in the rules.

(1) to (10): The Board agrees with the comment to delete the term “sterile” from R 338.532 and R 338.533, as

the rules should regulate sterile and non-sterile compounding. For consistency “sterile” will also be deleted from

R 338.531.

(4): The Board does not agree with modifying the rules to clarify that USP applies to entities other than

pharmacies, including private physician offices, dental offices, podiatric offices, veterinarian offices, infusion

centers, surgical outpatient facilities, hospitals, and health facilities. The Board agrees with further expanding

the term “distributes” to “dispenses, provides, distributes, or otherwise furnishes.”

(5): The Board agrees with the comment that only the FDA should inspect an outsourcing facility that handles

compounded pharmaceuticals in this state which is registered as an outsourcing facility by the FDA.

(6)(a): The Board does not agree with changing supervision to personal charge. The pharmacist must be on site.

(6)(c)(iv): The Board does not agree with listing the entities that provide accreditation in the rules because

adding entities or taking them off of the list would require modifying the rules.

(6)(d)(i), (ii), and (iii): The Board accepts the comment to add the proposed language for clarity, and also

reference R 338.582 for patient specific drugs.

New: The Board agrees with adding the language “An outsourcing facility may compound drugs using

bulk drug substances that appear on a list established by the Secretary identifying bulk drug substances

for which there is a clinical need” if consistent with Federal law and is not already included in the

definition of an outsourcing facility.

Rule 338.534

Rule Numbers

Section (5)

Inspections.

Commenter

Carlson/MHA

Comment

Under the “Inspections of applicants and licensees” section, the MHA feels the inspection should

34

also exclude data gathered by the licensed health facility for quality improvement or professional

practice review purposes. The collection of quality improvement data enables providers to work to

improve patient safety and reduce the incidence of adverse events. This data could be incorrectly

interpreted, which may deter providers from collecting data for quality improvement purposes.

Professional practice evaluation is the process by which a health facility, using its own medical

staff, performs a peer review of a privileged practitioner's professional practice for performance

improvement and to ensure safe and high-quality patient care. The data should be left out of the

inspection to ensure honest research and responses, which will ultimately lead to improved patient

safety and quality. Michigan hospitals are committed to transparency and share quality of care data

to state residents at verifymicare.org.

Also, add the Joint Commission to (4).

Section (4)

Sapita/MPA

Remove “the NABP-VPP” replace with “a board approved accrediting organization.”

Rules Committee (4): The Rules Committee agrees with the comment to replace the existing language with “a board approved accrediting

Response

organization” instead of listing each organization.

(5): The Rules Committee agrees with Carlson/MHA’s comments and recommends adding the following language, (5)

“The inspection shall not extend to information gathered by a licensed health facility for quality improvement or

professional practice review.”

R 338.534 Inspections.

Rule 34. (1) A pharmacy located outside of this state that applies for licensure in this state as a pharmacy that will not ship

compounded sterile pharmaceutical products into this state, shall submit to the department a copy of its most recent

pharmacy inspection that was performed within the last 2 years.

(2) An applicant for a new pharmacy located in this state shall have an inspection conducted by the department or its

designee prior to licensure.

(3) An applicant for licensure of a pharmacy that will provide sterile compounded pharmaceuticals shall have all of the

following:

(a) An onsite physical inspection conducted by any of the following:

(i) The department.

(ii) The national association of boards of pharmacy verified pharmacy program (NABP-VPP).

(iii) An accrediting organization according to R 338.532.

35

(iv) A state licensing agency of the state in which the applicant is a resident and in accordance with the NABP’s multistate

pharmacy inspection blueprint program.

(b) A physical inspection and corresponding report completed within 18 months of application.

(c) A physical inspection and corresponding report that demonstrates compliance with all applicable standards that are

adopted by reference in R 338.533.

(4) An out-of-state pharmacy that intends to ship sterile compounded pharmaceutical products into this state shall obtain an

inspection from a board approved accrediting organization the NABP-VPP every 18 months.

(5) The inspection shall not extend to information gathered by a licensed health facility for quality improvement or

professional practice review.

Board Response

(4): The Board agrees with the comment to replace the existing language with “a board approved accrediting

organization” instead of listing each organization.

(5): The Board agrees with Carlson/MHA’s comments and recommends adding the following language, (5) “The

inspection shall not extend to information gathered by a licensed health facility for quality improvement or

professional practice review.”

Department

Response

(5): The Department does not agree with adding the suggested language as it may be relied on by a pharmacy for

a basis to refuse to comply with a Department investigative subpoena. Although Article 17 protects hospital

peer review from disclosure in Department investigations, the Department is not aware of this privilege being

extended to pharmacies within such facilities. Additionally, the statutory privilege provided to hospitals relates

to only data tied to the reduction of mortality rate and improvement of patient care.

Rule 338.535

Rule Numbers

Section (1)

Discontinuing sterile compounding services; requirements to resume sterile compounding services.

Commenter

Kuhns/Portage

Pharmacy

Comment

Add “or outsourcing facility” to (1): A sterile compounding pharmacy or outsourcing facility.

Section (3)

Add the following:

(3) An outsourcing facility shall not resume providing sterile compounding services in this state

until the outsourcing facility is approved by the department and verifies that it is compliant by an

organization satisfying the requirements of R 338.533(4-10).

36

Rules Committee (1) and (3): The Rules Committee agrees with the suggested changes to provisions (1) and (3).

Response

R 338.535 Discontinuing sterile compounding services; requirements to resume sterile compounding services.

Rule 35. (1) A sterile compounding pharmacy or outsourcing facility that ceases to provide sterile compounding services in

this state shall notify the department within 30 days of ceasing to provide sterile compounding services.

(2) A pharmacy shall not resume providing sterile compounding services in this state until the pharmacy is approved by the

department and is accredited or verifies that it is USP compliant by an organization satisfying the requirements of R

338.532(1).

(3) A pharmacy shall apply for approval to resume sterile compounding services by submitting to the department an

application on a form provided by the department together with the requisite fee.

(4) An outsourcing facility shall not resume providing sterile compounding services in this state until the outsourcing facility

is approved by the department and verifies that it is compliant by an organization satisfying the requirements of R 338.533(4-

7).

Board Response

(1) and (3): The Board agrees with the changes to provisions (1) and (3).

Rule 338.536

Rule Numbers

Section (2)

Housing of a pharmacy.

Commenter

Baran/Ferris

Comment

The 150 square feet requirement has been in the rule for over 30 years. Given the increase in

technology and the number of drugs requiring an increase in space this minimum should be at least

250 square feet for any new licenses issued. 250 square feet is used by a couple of the great lake

states.

Baskerville

Baran

This rule states that there should be not less than 10 feet of free counterspace, but it does not

consider the amount of technology that a pharmacy utilizes or the technicians. A minimum of 10

feet is too small when you account for computers, printers, fax machines, and separate workspaces

for the technicians. Add: not less than 16 feet of free workspace.

Section (3)

Add exception here for restroom breaks and assisting patients in the over the counter purchases.

Rules Committee (2) and (3): The Rules Committee does not agree with the suggested modifications to (2) or (3) as the current space

37

Response

requirement is appropriate and the pharmacist is still on the premises while in the restroom.

R 338.536 Housing of a pharmacy.

Rule 36. (1) All professional and technical equipment and supplies and prescription drugs must be housed in a suitable, well-

lighted, and well-ventilated room or department with clean and sanitary surroundings.

(2) All pharmacies shall have a prescription department that is devoted primarily to the practice of pharmacy that occupies

not less than 150 square feet of space, and that includes a prescription counter that provides not less than 10 square feet of free

working surface. For each additional pharmacist who is on duty at any 1 time, the free working space must be increased by

not less than 4 square feet. The prescription counter must be kept orderly and clean. The space behind the prescription

counter must be sufficient to allow free movement within the area and must be free of obstacles.

(3) All pharmacies that occupy less than the entire area of the premises owned, leased, used, or controlled by the licensee

must be permanently enclosed by partitions from the floor to the ceiling. All partitions must be of substantial construction and

must be securely lockable so that drugs and devices that can be sold only by a pharmacist will be unobtainable during the

absence of the pharmacist. Only the area of the premises owned, leased, used, or controlled by the licensee may be identified

by the terms “drugstore,” “apothecary,” or “pharmacy,” or by use of a similar term or combination of terms as listed in

section 17711(2) of the code, MCL 333.17711(2). A pharmacy department must be locked when the pharmacist is not on the

premises.

Board Response

(2) and (3): The Board does not agree with the suggested modifications to (2) or (3) as the current space

requirement is appropriate and the pharmacist is still on the premises while in the restroom.

Rule 338.537

Rule Numbers

Section (2)

Professional and technical equipment and supplies.

Commenter

Baskerville

Comment

This rule does not give any guidelines about the refrigerator and it does not give any requirements

on a freezer. Add: a refrigerator that has a maximum temperature of 35 degrees Fahrenheit and a

freezer that has a maximum temperature of 0 degrees Fahrenheit if necessary, of reasonable capacity

located in the pharmacy department.

Rules Committee (2): The Rules Committee does not agree with the comment to add requirements on a freezer as the pharmacist must use

Response their professional judgment and this is part of professional responsibility.

38

R 338.537 Professional and technical equipment and supplies.

Rule 37. A pharmacy must be equipped with all of the following:

(a) Drawers, shelves, and storage cabinets.

(b) A sink that has hot and cold running water.

(c) A refrigerator of reasonable capacity located in the pharmacy department.

(d) Current editions or revisions of the Michigan pharmacy laws and rules, and not less than 2 current or revised pharmacy

reference texts that pertain to pharmacology, drug interactions, or drug composition. A current electronic version of

pharmacy laws, rules, and pharmacy reference texts, including accessible internet versions, meets the requirements of this

subrule.

Board Response

(2): The Board does not agree with the comment to add requirements on a freezer as the pharmacist must use

their professional judgment and this is part of professional responsibility.

Rule 338.538

Rule Numbers

Section (d)

Closing pharmacy.

Commenter

Baran/Ferris

Comment

Change this to 14 days to coincide with federal requirements. Should there be a provision regarding

the result when a pharmacist passes away. What happens to the pharmacy license? Is a pharmacy

license renewal the same process as the initial process?

Rules Committee (1)(d): The Rules Committee does not agree with changing 15 days to 14 days as this requirement is necessary when the

Response

pharmacy is registered with the DEA. One day does not have any effect on the public’s safety.

The Rules Committee does not agree with the comment to add a rule regarding the death of a PIC as there is already a

rule regarding changes to a PIC.

R 338.538 Closing pharmacy.

Rule 38. (1) A pharmacy that is ceasing operations shall return to the department the pharmacy license and the controlled

substance license, if applicable, and shall provide the department with written notification of all of the following at least 15

days prior to closing:

(a) The effective date of closing.

(b) The disposition of controlled substances.

(c) The disposition of non-controlled substances.

39

(d) The disposition of records and prescription files.

(2) A pharmacy shall comply with all applicable federal requirements for discontinuing operation as a pharmacy that

dispenses controlled substances.

Board Response

(1)(d): The Board does not agree with changing 15 days to 14 days as this requirement is necessary when the

pharmacy is registered with the DEA. One day does not have any effect on the public’s safety.

The Board does not agree with the comment to add a rule regarding the death of a PIC as there is already a rule

regarding changes to a PIC.

Rule 338.551

Manufacturer license; application.

Rule Numbers

Commenter

Sapita/MPA

Comment

MPA believes that R 338.493a(3), proposed R 338.561(b), should not be deleted and should read ”

If the total number of dosage units of all prescription drugs that are prepared or compounded by a

pharmacy for resale, compounding, or dispensing by another person, as defined in section 1106 of

the code, during any consecutive 12-month period is more than 5% of the total number of dosage

units of prescription drugs prepared by the pharmacy during the 12-month period, then the

pharmacy is a manufacturer as defined in section 17706(1) of the code.”

Rules Committee The Rules Committee agrees that prior R 338.493a(3), proposed R 338.561(b), should not be deleted, but should be

Response moved to R 338.551 as it applies to a manufacturer license.

R 338.551 Manufacturer license; application.

Rule 51. (1) An applicant for a manufacturer license shall submit to the department a completed application on a form

provided by the department with the requisite fee.

(2) An applicant shall provide all of the following information:

(a) A criminal history background check required pursuant to section 17748(6) of the code, MCL 333.17748(6).

(b) Verification or certification from every state or province where the applicant is currently licensed or has ever held a

license.

(c) Certified copies of articles of incorporation or certificates of partnership and assumed name certificates, if applicable.

(d) The identity and address of each partner, officer, or owner, as applicable.

(e) A completed compliance checklist for manufacturers.

(f) A list or a catalog of all drug products or devices to be manufactured by the facility.

40

(g) Unless exempt under section 17748(2) of the code, MCL 333.17748(2), the name and license number of the pharmacist

designated as the pharmacist in charge (PIC).

(h) A copy of the FDA certification for the site to be licensed, if an applicant is a manufacturer of biologicals.

(i) An inspection from the manufacturer’s resident state board of pharmacy or verified-accredited wholesale distributors

(VAWD) accreditation dated not more than 2 years prior to the application.

(3) A separate license is required for each location where prescription drugs or devices are manufactured.

(4) A pharmacy is a manufacturer and shall obtain a manufacturer license if it prepares or compounds prescription drugs for

resale, compounding, or dispensing by another person in an amount that exceeds 5% of the total number of dosage units of

prescription drugs prepared by the pharmacy during a consecutive 12-month period.

Board Response

The Board agrees that prior R 338.493a(3), proposed R 338.561(b), should not be deleted entirely from the rules.

However, the Board recommends moving R 338.561(b)(b) to R 338.551 as it applies to a manufacturer license.

Rule 338.561

Rule Numbers

Section (b)

Pharmacy as wholesale distributor; licensure.

Commenter

Baran/Ferris

Comment

Need to delete (b) entirely as (b) is in violation of 333.17748a(7) and the Drug Quality and Security

Act section 503A, a pharmacy may only compound a drug for an identified individual patient based

on the receipt of a valid prescription order, or a notation, approved by the prescribing practitioner.

A pharmacy may not compound drugs for resale.

Baskerville

This draft rule does not consider the federal law that states that a pharmacy cannot sell another

pharmacy a compounded product. Delete (b).

Rules Committee The Rules Committee does not agree with deleting (b) from the rules, but instead recommends moving (b) to R 338.551

Response as it applies to a manufacturer license.

R 338.561 Pharmacy as wholesale distributor; licensure.

Rule 61. A pharmacy that transfers prescription drugs or devices shall obtain a wholesale distributor license if it satisfies

either of the following:

(a) Distributes distributes more than 5% of the total dosage units of prescription drugs dispensed during any consecutive

12-month period, except in the following circumstances:

(a) The distribution of a drug a drug among hospitals or other health care entities which are under common control.

41

(b) Intracompany distribution of any drug between members of an affiliate, defined pursuant to the Federal Food, Drug,

and Cosmetic Act of 2016, 21 USC section 360eee(1), or within a manufacturer.

(c) Distribution of a drug by a charitable organization to a nonprofit affiliate of the organization, defined pursuant to the

Federal Food, Drug, and Cosmetic Act of 2016, 21 USC section 360eee(1).

(d) Distribution of a product for emergency medical reasons including a public health emergency declaration pursuant to

section 319 of the Public Health Service Act.

(b) Prepares or compounds prescription drugs for resale, compounding or dispensing by another person in an amount that

exceeds 5% of the total number of dosage units prepared and compounded for dispensing by the pharmacy during a

consecutive 12-month period.

Board Response

The Board does not agree with deleting (b) from the rules, but instead recommends moving (b) to R 338.551 as

it applies to a manufacturer license.

The Board also recommends modifying (a) as it is inconsistent with the Drug Quality and Security Act.

Rule 338.563

Rule Numbers

Section (2)(i)(B)

Wholesale distributor; application for licensure; requirements.

Commenter

Comment

Roath/SpartanNash While the training requirements under Rule 63, Subrule (2)(i)(B) are advisable to a person in the

facility manager position, a lack of accredited or universally recognized training program makes

the path to compliance with this rule unclear. Given that no accredited program exists, employers

should have the discretion as to exactly what kind of training they require of an individual in this

position absent a regulatory requirement. Additionally, Subrule (2)(i)(C) establishes experience

requirements that should address any concerns as to whether a facility manager is qualified to fill

their position. As such, we recommend that Subrule (2)(i)(C) and all requirements under this

subrule be removed from the rules as proposed.

Sapita/MPA

MPA is not aware of any specific training programs that cover all listed topics and believes this

responsibility should lie with the wholesaler rather than the board.

Rules Committee (2)(i)(B): The Rules Committee members are split on whether the term “training program” should be modified. The

Response comments require further discussion.

42

R 338.563 Wholesale distributor; application for licensure; requirements.

Rule 63. (1) An applicant for a wholesale distributor license shall submit to the department a completed application on a

form provided by the department with the requisite fee. A wholesale distributor includes virtual manufacturers.

(2) An applicant shall provide all of the following information:

(a) A criminal history background check required pursuant to section 17748(6) of the code, MCL 333.17748(6).

(b) Proof of registration or licensure from every state where the applicant currently holds or has ever held a license or

registration.

(c) Certified copies of articles of incorporation or certificates of partnership and assumed names if applicable.

(d) The identity and address of each partner, officer, or owner as applicable.

(e) A completed compliance checklist.

(f) A list or catalog of all drug products and devices to be distributed.

(g) A copy of the FDA certification for the site to be licensed, if the applicant is distributing biologicals.

(h) Unless exempt under section 17748(2) of the code, MCL 333.17748(2), the name and the license number of the pharmacist

designated as the pharmacist in charge (PIC) or the name of the facility manager. For individuals designated as a facility

manager, the applicant shall provide the following:

(i) Proof, in the form of an affidavit, that the facility manager has achieved the following:

(A) A high school equivalency education, or higher, defined as 1 of the following:

(1) A high school diploma.

(2) A general education development certificate (GED).

(3) A parent-issued diploma for home schooled individuals.

(4) Completion of post-secondary education, including an associate’s, bachelor’s, or master’s degree.

(B) Completion of a training program that includes, but is not limited to, all of the following subjects:

(1) Knowledge and understanding of laws in this state and federal laws relating to the distribution of drugs and devices.

(2) Knowledge and understanding of laws in this state and federal laws relating to the distribution of controlled substances.

(3) Knowledge and understanding of quality control systems.

(4) Knowledge and understanding of the USP standards relating to the safe storage and handling of prescription drugs.

(5) Knowledge and understanding of pharmaceutical terminology, abbreviations, dosages, and format.

(C) Experience equal to either of the following:

(1) A minimum of 1 year of work experience related to the distribution or dispensing of prescription drugs or devices where

the responsibilities included, but were not limited to, recordkeeping.

43

(2) Previous or current employment as a designated representative of a wholesale distributor certified by the VAWD of

NABP.

Board Response

The Board does not agree with the comments to modify the term “training program” or the requirements of a

“training program” there is no requirement in the rule that the program be taught by a Board approved program

or an educational institution, nor is the training program required to be taught by any specific entity. The Board

believes the rule requires the “appropriate education and experience” for a facility manager, which is what is

required by the Code.

Rule 338.582

Rule Numbers

Section (3)

Prescription drug labeling and dispensing.

Commenter

Baran/Ferris

Comment

Need to delete “or the reference "G.Eq.," "generic," or "generic equivalent" in the case of

multi-ingredient products” from the rule. The rule was created before computer software was

standard practice in pharmacy over 30 years ago. This terminology is no longer used on

prescription labels because computers made it obsolete.

Section (3)

Kurzman/NACDS Delete (3) for the following reasons:

Under R 338.582 (2) and (3), the Board proposed rule changes that address labeling requirements

when a brand vs. generic drug is dispensed. Language under subrule (2)(g) and (i) specifies that

prescription labels must include the medication name and the manufacturer or supplier of the drug if

the drug has no brand name, unless the prescriber indicates “do not label”. Notably, the proposed

language further specifies under subrule (3) that when “a drug is dispensed that is not the brand

prescribed… the prescription label must indicate both the name of the brand prescribed and the

name of the brand dispensed. If the dispensed drug does not have a brand name, the prescription

label must indicate the name of the brand prescribed followed by the generic name of the drug

dispensed or the reference "G.Eq.," "generic," or "generic equivalent" in the case of multi-ingredient

products.” However, if the if the prescriber indicates "do not label”… [the] subrule does not

apply…"

We are concerned that altogether, the language in subrule (2)(g) and (i) and in subrule (3) is

duplicative and may lead to confusion. To simplify and clarify this issue, we recommend that

44

subrule (3) be stricken entirely as that provision is redundant to the requirements outlined in subrule

(2)(g) and (i).

Eid/Ferris

Although being worked on within the Pharmacy Technician specific rules, consider the following

for both this section and the Pharmacy Technician rule set. Tech-check-tech, or as some states are

now calling it "accuracy checking" or “technician product verifiction” has been successfully and

safely practiced in some states for decades. There are approximately 20 studies to date on the topic

in various settings including community based and health systems. Adams et al reviewed and

demonstrated safety data, including that results of 11 studies published since 1978 indicate that

technicians’ accuracy in performing final dispensing checks is very comparable to pharmacists’

accuracy (mean ± S.D., 99.6% ± 0.55% versus 99.3% ± 0.68%, respectively. Frost et al also

reviews data in the community setting and also showed that in 2 studies that reported accuracy rates,

pharmacy technicians performed at least as accurately as pharmacists (99.445 vs 99.73%, P = .484;

99.95 vs 99.74, P < .05). In addition, there are multiple pilot and research programs in states such as

Wisconsin, Tennessee, Iowa, South Dakota, and more which have been studying the workflow and

outcomes of implementing these models. I encourage the board and other stakeholders to move

forward on this as it will only help to improve patient care initiatives and allow for pharmacists to

spend more time with patients as demonstrated by Andreski et al. I'd also encourage the board to

refer to Adams for deliberations of the Idaho regulatory board on advancing technician practice,

which an example from.

Rules Committee (3): The Rules Committee agrees with the comment to delete "G.Eq.," "generic," or "generic equivalent" in the case of

Response

multi-ingredient products” from the rule but does not agree with deleting the rule in its entirety as the use of generic

needs to be disclosed if being used.

I n response to the Eid comment, the authority for a pharmacy technician to provide product verification is included in

the proposed pharmacy technician rules so will not be addressed in these rules.

R 338.582 Prescription drug labeling and dispensing.

Rule 82. (1) All labeling of prescription drugs must comply with the requirements of the code and the Federal Food, Drug,

and Cosmetic Act of 2016, 21 U.S.C. sections 351 to 399f.

(2) All containers in which prescription medication is dispensed must bear a label that contains, at a minimum, all of the

following information:

(a) Pharmacy name and address.

45

(b) Prescription number.

(c) Patient's name.

(d) Date the prescription was most recently dispensed.

(e) Prescriber's name.

(f) Directions for use.

(g) The name of the medication and the strength, unless the prescriber indicates "do not label."

(h) The quantity dispensed, if applicable.

(i) The name of the manufacturer or supplier of the drug if the drug has no brand name, unless the prescriber indicates “do

not label.”

(3) If a drug is dispensed that is not the brand prescribed, the pharmacy shall notify the purchaser and the prescription label

must indicate both the name of the brand prescribed and the name of the brand dispensed. If the dispensed drug does not have

a brand name, the prescription label must indicate the name of the brand prescribed followed by the generic name of the drug

dispensed or the reference "G.Eq.," "generic," or "generic equivalent" in the case of multi-ingredient products. This subrule

does not apply if the prescriber indicates "do not label."

(4) If drug product selection takes place, the brand name or the name of the manufacturer or supplier of the drug dispensed

must be noted on the prescription.

(5) This rule does not apply to pharmacy services provided in a medical institution.

Board Response

(a): Typographical error – capitalize name of Act.

(3): The Board agrees with the comment to delete "G.Eq.," "generic," or "generic equivalent" in the case of

multi-ingredient products” from the rule but does not agree with deleting the rule in its entirety as the use of

generic needs to be disclosed if being used.

The authority for a pharmacy technician to provide product verification is included in the proposed pharmacy

technician rules.

Rule 338.584

Rule Numbers

Section (4)

Noncontrolled prescriptions.

Commenter

Baran/Ferris

Comment

Modify to: (4) A noncontrolled prescription is valid for 1 year from the date the prescription was

issued.

This makes it clear this only applies to noncontrolled prescriptions.

Rules Committee The Rules Committee does not agree with the comment as “noncontrolled” is used in the heading and adding

46

Response

“noncontrolled” would therefore be redundant.

R 338.584 Noncontrolled prescriptions.

Rule 84. (1) A prescriber who issues a prescription for a noncontrolled prescription drug shall date the prescription; provide

a manual signature on the prescription, as defined in R 338.501(1)(h) of these rules; and ensure that the prescription contains

all of the following information:

(a) The full name of the patient for whom the drug is being prescribed.

(b) The prescriber’s printed name and address.

(c) The drug name and strength.

(d) The quantity prescribed.

(e) The directions for use.

(f) The number of refills authorized.

(2) A prescriber shall ensure that a prescription is legible and that the information specified in subrule (1)(c) to (f) of this rule

is clearly separated.

(3) A prescriber shall not prescribe more than either of the following on a single prescription form as applicable:

(a) For a prescription prescribed in handwritten form, up to 4 prescription drug orders.

(b) For a prescription prescribed on a computer-generated form or a preprinted list or produced on a personal computer or

typewriter, up to 6 prescription drug orders.

(4) A prescription is valid for 1 year from the date the prescription was issued.

(5) A prescriber may electronically transmit a noncontrolled substance prescription to the pharmacy of the patient’s choice

by utilizing a system that includes all of the following:

(a) A combination of technical security measures such as, but not limited to, those listed in security standards for the

protection of electronic protected health information set forth in 45 C.F.R. section 164.312 (2013) that implements the Federal

Health Insurance Portability and Accountability Act of 1996 (HIPAA), to ensure all of the following:

(i) Authentication of an individual who prescribes or dispenses.

(ii) Technical non-repudiation.

(iii) Content integrity.

(iv) Confidentiality.

(b) An electronic signature as defined in R 338.501(1)(g). An electronic signature is valid when it is used to sign a

noncontrolled prescription.

47

(c) Appropriate security measures to invalidate a prescription if either the electronic signature or prescription record to

which it is attached or logically associated is altered or compromised following transmission by the prescriber. The electronic

prescription may be reformatted to comply with industry standards provided that no data is added, deleted, or changed.

(6) The electronic prescription must meet all requirements of the HIPAA.

(7) The electronic prescription must permit the prescriber to instruct the pharmacist to dispense a brand name drug product

provided that the prescription includes both of the following:

(i) The indication that no substitute is allowed, such as “dispense as written” or “DAW.”

(ii) The indication that no substitute is allowed and that it is a unique element in the prescription.

(8) If the prescription is transmitted electronically, the prescriber shall generate and transmit the prescription in a format

that can be read and stored by a pharmacy in a retrievable and readable form. The electronic prescription must identify the

name of the pharmacy intended to receive the transmission, and must include the information identified in subrule (1) of this

rule.

(9) The electronic prescription must be preserved by a licensee or dispensing prescriber for not less than 5 years. A paper

version of the electronic prescription must be made available to an authorized agent of the board upon request. A secured

copy must be retained for a minimum of 1 year by the transaction service vendor for record-keeping purposes and must be

shared only with the parties involved in the transaction except as otherwise permitted by state or federal law.

(10) An electronic signature that meets the requirements of this rule has the full force and effect of a handwritten signature

on a paper-based written prescription.

(11) A pharmacy shall keep the original prescription record for 5 years. After 3 years, a pharmacy may make an electronic

duplicate of the original paper prescription, which will become the original prescription. A pharmacy shall present a paper

copy of the electronic duplicate of the prescription to an authorized agent of the board upon request.

(12) This rule does not apply to pharmacy services provided in a medical institution.

Board Response

The Board does not agree with the comment as “noncontrolled” is used in the heading and adding

“noncontrolled” would, therefore, be redundant.

(5)(a): Typographical error. Capitalize federal Act.

Rule 338.585

Rule Numbers

Section (b)

Customized patient medication package.

Commenter

Baran/Ferris

Comment

Change the first sentence to: “A CPMP must be accompanied by any mandated patient information

required under federal law.”

48

This would cover any medication guides required.

Rules Committee The Rules Committee agrees with the comment.

Response

R 338.585 Customized patient medication package.

Rule 85. (1) A pharmacist may, with the consent of the patient, or the patient’s caregiver, or a prescriber, provide a

customized patient medication package (CPMP). A CPMP is a package that is prepared by a pharmacist for a specific patient

and that contains 2 or more prescribed solid oral dosage forms. The CPMP is designed and labeled to indicate the day and

time or period of time that the contents within each CPMP are to be taken. The person who dispenses the medication shall

instruct the patient or caregiver on the use of the CPMP.

(2) If medication is dispensed in a CPMP, all of the following conditions must be met:

(a) Each CPMP must bear a readable label that states all of the following information:

(i) A serial number for the CPMP and a separate identifying serial number for each of the prescription orders for each of the

drug products contained in the CPMP.

(ii) The name, strength, physical description, and total quantity of each drug product contained in the CPMP.

(iii) The name of the prescriber for each drug product.

(iv) The directions for use and cautionary statements, if any, contained in the prescription order for each drug product in the

CPMP.

(v) The date of the preparation of the CPMP.

(vi) An expiration date for the CPMP. The date must not be later than the earliest manufacturer’s expiration date for any

medication included in the CPMP or 60 days after the date of dispensing.

(vii) The name, address, and telephone number of the dispenser.

(viii) Any other information, statements, or warnings required for any of the drug products contained in the CPMP.

(b) A CPMP must be accompanied by any mandated patient information required under federal law. Alternatively, required

medication information may be incorporated by the pharmacist into a single educational insert that includes information

regarding all of the medications in the CPMP.

(c) At a minimum, each CPMP must be in compliance with the United States Pharmacopeia (USP) and national formulary, as

defined in section 17706(2) of the code, MCL 333.17706(2), for moisture permeation requirements for a class b single-unit or

unit-dose container. Each container must be either non-reclosable or so designed as to show evidence of having been opened.

Each CPMP must comply with all of the provisions of the poison prevention packaging act of 2016, 15 U.S.C. sections 1471 to

1477.

49

(d) When preparing a CPMP, the dispenser shall take into account any applicable compendial requirements or guidelines,

the physical and chemical compatibility of the dosage forms placed within each container, and any therapeutic

incompatibilities that may attend the simultaneous administration of the medications. Medications must not be dispensed in

CPMP packaging in any of the following situations:

(i) The USP monograph or official labeling requires dispensing in the original container.

(ii) The drugs or dosage forms are incompatible with packaging components or each other.

(iii) The drugs are therapeutically incompatible when administered simultaneously.

(iv) The drug products require special packaging.

(e) If 2 medications have physical characteristics that make them indistinguishable from each other, then the medication

must not be packaged together in the same CPMP.

(f) Medications that have been dispensed in CPMP packaging shall not be returned to stock or dispensed to another patient

when returned to the pharmacy for any reason. If a prescription for any drug contained in the CPMP is changed, then a new

appropriately labeled CPMP must be prepared for the patient.

(g) In addition to all individual prescription filing requirements, a record of each CPMP dispensed must be made and filed.

At a minimum, each record must contain all of the following information:

(i) The name and address of the patient.

(ii) The serial number of the prescription order for each drug product contained in the CPMP.

(iii) Information identifying or describing the design, characteristics, or specifications of the CPMP sufficient to allow

subsequent preparation of an identical CPMP for the patient.

(iv) The date of preparation of the CPMP and the expiration date assigned.

(v) Any special labeling instructions.

(vi) The name or initials of the pharmacist who prepared the CPMP.

Board Response

Rule 338.587

The Board agrees with the comment.

Prescription refill records; manual systems; profile systems; automated pharmacy data systems;

nonapplicability to medical institution service; record confidentiality; and access.

Rule Numbers

Section (2)

Commenter

Baran/Ferris

Comment

Delete (2) entirely as this method is outdated by the use of computers. This part is more than 40

years old with no one using this process today.

Section (3)(vii)

Sapita/MPA

Remove “name of the manufacturer.”

50

and (4)(vii)

Section (6)

Sapita/MPA

Subrule (2) should be included in this section.

Rules Committee (2): The Rules Committee does not agree with the comment as the manual method may be used in a natural disaster.

Response

(3)(viii) and (4)(viii): The comment was withdrawn.

(6): Subrule will be added back in as its deletion was a typographical error.

R 338.587 Prescription refill records; manual systems; profile systems; automated pharmacy data systems; nonapplicability to

medical institution service; record confidentiality; and access.

Rule 87. (1) A pharmacist shall record prescription refills using only 1 of the systems described in subrule (2), (3), or (4) of

this rule and in compliance with the provisions of subrule (2), (3), or (4) of this rule, as applicable.

(2) A pharmacy may utilize a manual system of recording refills if the system is in compliance with both of the following

criteria:

(a) The amount and date dispensed must be entered on the prescription in an orderly fashion and the dispensing pharmacist

initials the entry. If the pharmacist only initials and dates the prescription, then the full face amount of the prescription must

be deemed dispensed.

(b) If the drug that is dispensed is other than the brand prescribed or if the prescription is written generically, then the name

of the manufacturer or supplier of the drug dispensed must be indicated on the prescription.

(3) A pharmacy may utilize a uniform system of recording refills if the system is in compliance with all of the following

criteria:

(a) Records must be created and maintained in written form. All original and refill prescription information for a particular

prescription appears on single documents in an organized format. The pharmacy shall preserve the records for 5 years. The

records are subject to inspection by the board or its agents.

(b) The following information for each prescription must be entered on the record:

(i) The prescription number.

(ii) The patient's name and address.

(iii) The prescriber's name.

(iv) The prescriber's federal drug enforcement administration (DEA) number, if appropriate.

(v) The number of refills authorized.

(vi) The "dispense as written" instructions, if indicated.

51

(vii) The name, strength, dosage form, quantity, and name of the manufacturer of the drug prescribed, and the drug

dispensed originally and upon each refill. If the drug dispensed is other than the brand prescribed or if the prescription is

written generically, then the name of the manufacturer or supplier of the drug dispensed must be indicated.

(viii) The date of issuance of the prescription.

(ix) The date and identifying designation of the dispensing pharmacist for the original filling and for each refill.

(c) Prescription entries must be made on the record at the time the prescription is first filled and at the time of each refill,

except that the format of the record may be organized so that information already entered on the record may appear for a

prescription or refill without reentering the information. The dispensing pharmacist is responsible for the completeness and

accuracy of the entries and must initial the record each time a prescription is filled or refilled.

(d) The information required by subdivision (b) of this subrule must be entered on the record for all prescriptions filled at a

pharmacy, including nonrefillable prescriptions. This requirement is in addition to the requirements set forth in R 338.586.

(4) A pharmacy may utilize a uniform automated data processing system of recording refills if the system is in compliance

with all of the following criteria:

(a) All information that is pertinent to a prescription must be entered on the record, including all of the following

information:

(i) The prescription number.

(ii) The patient's name and address.

(iii) The prescriber's name.

(iv) The prescriber's federal DEA number, if appropriate.

(v) The number of refills authorized.

(vi) Whether the drug must be dispensed as written.

(vii) The name, strength, dosage form, quantity, and name of the manufacturer of the drug prescribed and the drug

dispensed originally and upon each refill. If the drug dispensed is other than the brand prescribed or if the prescription is

written generically, then the name of the manufacturer or supplier of the drug dispensed must be indicated.

(viii) The date of issuance of the prescription.

(ix) The date and identifying designation of the dispensing pharmacist for the original filling and for each refill.

(b) Prescription entries must be made on the record at the time the prescription is first filled and at the time of each refill,

except that the format of the record may be organized so that information already entered on the record may appear for a

prescription or refill without reentering the information. The dispensing pharmacist is responsible for the completeness and

accuracy of the entries. The pharmacy shall preserve the records on-site for 5 years. The records are subject to inspection by

the board or its agents. A procedure must be established to facilitate inspections.

52

(c) The required information must be entered on the record for all prescriptions filled at the pharmacy, including

nonrefillable prescriptions. This requirement is in addition to the requirements set forth in R 338.586.

(d) The recording system must provide adequate safeguards against improper manipulation, the alteration of records, and

the loss of records.

(e) The recording system must have the capability of producing a printout of all original and refilled prescription data,

including a prescription-by-prescription and refill-by-refill audit trial for any specified strength and dosage form of a

controlled substance by either brand or generic name or an audit trail of controlled substance prescriptions written for a

particular patient or by a particular practitioner. A printout of an audit trail or other required information must be made

available to an authorized agent of the board upon request. The prescription data must be maintained for 5 years. Data older

than 16 months must be provided within 72 hours of the time the request is first made by the agent. Prescription data for the

most current 16 months must be readily retrievable on site and available for immediate review.

(f) If the automated data processing system is inoperative for any reason, then the pharmacist shall ensure that all refills are

authorized and that the maximum number of refills is not exceeded. When the automated data processing system is restored to

operation, the pharmacist shall enter the information regarding prescriptions filled and refilled during the inoperative period

into the automated data processing system within 48 hours.

(g) A pharmacy shall make arrangements with the supplier of data processing services or materials to ensure that the

pharmacy continues to have adequate and complete prescription and dispensing records if the relationship with the supplier

terminates for any reason. A pharmacy shall ensure continuity in the maintenance of records.

(h) The automated data processing system must be an integrated system that is capable of complying with all of the

requirements of these rules.

(5) This rule does not apply to pharmacy services provided in a medical institution.

(6) Records that are created under subrule (2), (3), or (4) of this rule are subject to the same requirements regarding

confidentiality and access that apply to original prescriptions.

Board Response

(2): The Board does not agree with the comment as the manual method may be used in a natural disaster.

(3)(viii) and (4)(viii): The comment was withdrawn.

(6): Subrule will be added back in as its deletion was a typographical error.

Rule 338.588

Rule Numbers

Section (1)

Automated devices.

Commenter

Sapita/MPA

Comment

Consider keeping the current rule, “An automated device means a device designed for the specific

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purpose of selling, dispensing, or otherwise disposing of any drug or device ordered by a

prescription.”

(1)(h)

MPA would like clarification if the location would need to be owned and operated by the pharmacy

and who would be responsible for the device.

Section (2)

Roath/SpartanNash Statutory changes that have occurred since the original rules regarding the use of automated

devices in healthcare settings, as well as the addition of Subrule (2)(h) in these proposed rules,

creates the potential for automated devices to be used in locations outside a pharmacy but at the

same physical address of the pharmacy. However, this is currently limited only to hospital settings.

Given that hospital pharmacies do not have any differentiation in license classification and, in some

circumstances, have the ability to operate as outpatient facilities, this creates an environment where

certain outpatient pharmacies are able to use these devices in capacities that are denied to

pharmacies in the community practice setting. To address this discrepancy, we recommend that

Rule 88, Subrule (2)(a) be modified to read “a pharmacy, or at the same physical address as the

pharmacy provided that the location of the device is owned and operated by the same legal entity as

the pharmacy.”

Section (3)

Baran/Ferris

Add this language following the first sentence in (3) “If the automated device contains controlled

substances, the pharmacy must obtain an additional controlled substance license for the automated

device as well as a DEA registration for the device.

Roath/SpartanNash

The current definition “automated device” in the Michigan Public Health Code and in the rules as

proposed encompasses several devices that may be used in workflow for tasks other than the

delivery of a medication to patient or other healthcare provider (e.g., counting machines and

packaging devices operated by pharmacy staff as part of the dispensing process). We feel that to

register each of these devices with the department goes beyond the intent of the Board and the

Department and will cause devices that do not require department oversight to be erroneously

registered with the Department. To correct this, we recommend that Rule 88, Subrule (3) be

modified to read: “A pharmacy that operates an automated device under this section to deliver a

drug or device directly to a patient or other healthcare provider shall notify the department of the

automated device’s location on a form provided by the department …”

Section (4)

Sapita/MPA

Remove “unless the prescriber’s office is affiliate with a hospital consisted with section 17760 of

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code, MCL 333.17760.” This is not relevant to this section.

Section (5)

Baran/Ferris

Sapita/MPA

Rule 338.3154 does not identify what is “board-approved error-prevention technology” and refers

back to rule 338.490 which is being rescinded by the new draft rules. 338.3154 and 338.490 go

around in a circle without ever defining “board-approved error-prevention technology”. Will have

to define “board-approved error-prevention technology” and list those that have been board

approved.

After “licensed” add “and located.”

Section (7)

(7)(a)

Roath/SpartanNash To provide consistency in the record keeping requirements for pharmacies and dispensing

prescribers, we recommend that Rule 88, Subrule (7)(b) be modified to read: “Records must be

maintained for 5 years by the pharmacy or dispensing prescriber and must be retrievable on

demand for review by an agent of the board…”

Sapita/MPA

After “pharmacy” add “or dispensing prescriber.”

Rules Committee (1): The Rules Committee does not agree with the comment to change the definition of “automated device” as the

Response

definition of automated device is from the Code.

(2): The Rules Committee agrees with the comment to add the language “a pharmacy, or at the same physical address as

the pharmacy provided that the location of the device is owned and operated by the same legal entity as the pharmacy.”

(3): The Rules Committee does not agree with the comment from Baran as this is already addressed in the controlled

substances rules but does agree with the comment from Roath as this is current practice.

(4): The Rules Committee does not agree with the comment as the purpose of the provision is to state when a pharmacy

can own a device at a dispensing prescriber’s office. A reference to (2)(h) should be added here.

(5): The Rules Committee agrees with the comment and recommends deleting the reference to R 338.3154. The

comment from MPA is withdrawn.

(7): The Rules Committee agrees with the comments.

R 338.588 Automated devices.

Rule 88. (1) “Automated device” means a mechanical system that performs an operation or activity, other than compounding

or administration, relating to the storage, packaging, dispensing, or delivery of a drug and that collects, controls, and

maintains transaction information.

(2) An automated device may be used only in the following locations:

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(a) A pharmacy, or at the same physical address as the pharmacy provided that the location of the automated device is owned

and operated by the same legal entity as the pharmacy.

(b) A hospital.

(c) A county medical care facility.

(d) A hospice.

(e) A nursing home.

(f) Other skilled nursing facility as defined in section 20109(4) of the code, MCL 333.20109(4).

(g) An office of a dispensing prescriber.

(h) A location affiliated with a hospital, but not at the same physical address as the pharmacy, that is owned and operated by

the hospital, consistent with section 17760 of the code, MCL 333.17760.

(3) A pharmacy that operates an automated device under this section to deliver a drug or device directly to an ultimate user

or other health care provider shall notify the department of the automated device’s location on a form provided by the

department. An automated device located within a licensed pharmacy must be used only by a pharmacist or his or her

pharmacy personnel under the personal charge of a pharmacist.

(4) If an automated device is used in a dispensing prescriber's office, the device must be used only to dispense medications to

the dispensing prescriber's patients and only under the control of the dispensing prescriber. A pharmacy shall not own,

control, or operate an automatic dispensing device in a dispensing prescriber's office, unless the prescriber’s office is affiliated

with a hospital consistent with section 17760 of the code, MCL 333.17760 and subrule (2)(h) of this rule.

(a) If a dispensing prescriber delegates the stocking of the automated device, then technologies must be in place and utilized

to ensure that the correct drugs are stocked in their appropriate assignment utilizing a board-approved error prevention

technology that complies with R 338.3154.

(b) A dispensing prescriber operating an automated device is responsible for all medications that are stocked and stored in

that device as well as removed from that device.

(c) If any medication or device is dispensed from an automated device in a dispensing prescriber’s office, then documentation

as to the type of equipment, serial numbers, content, policies, procedures, and location within the facility must be maintained

by the dispensing prescriber for review by an agent of the board. This documentation must include at least all of the following

information:

(i) Manufacturer name and model.

(ii) Quality assurance policy and procedure to determine continued appropriate use and performance of the automated

device.

(iii) Policy and procedures for system operation that addresses at a minimum all of the following:

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(A) Accuracy.

(B) Patient confidentiality.

(C) Access.

(D) Data retention or archival records.

(E) Downtime procedures.

(F) Emergency procedures.

(G) Medication security.

(H) Quality assurance.

(5) An automated device that is to be used for furnishing medications for administration to registered patients in any

hospital, county medical care facility, nursing home, hospice, or any other skilled nursing facility, as defined in section

20109(4) of the code, MCL 333.20109(4), must be supplied and controlled by a pharmacy that is licensed in this state. The use

of an automated device in these locations is not limited to the provisions of subrule (3) of this rule. If a pharmacist delegates

the stocking of the device, then technologies must be in place and utilized to ensure that the correct drugs are stocked in their

appropriate assignment utilizing bar-coding or another board-approved error-prevention technology that complies with R

338.3154. Each automated device must comply with all of the following provisions:

(a) A pharmacy operating an automated device is responsible for all medications that are stocked and stored in that device as

well as removed from that device.

(b) If any medication or device is dispensed from an automated device, then documentation as to the type of equipment, serial

numbers, content, policies, procedures, and location within the facility must be maintained by the pharmacy for review by an

agent of the board. The documentation must include at least all of the following information:

(i) Name and address of the pharmacy responsible for the operation of the automated device.

(ii) Name and address of the facility where the automated device is located.

(iii) Manufacturer name and model number.

(iv) Quality assurance policy and procedure to determine continued appropriate use and performance of the automated

device.

(v) Policy and procedures for system operation that address at a minimum all of the following:

(A) Accuracy.

(B) Patient confidentiality.

(C) Access.

(D) Data retention or archival records.

(E) Downtime procedures.

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(F) Emergency procedures.

(G) Medication security.

(H) Quality assurance.

(I) Ability to provide on demand to an agent of the board a list of medications qualifying for emergency dose removal without

pharmacist prior review of the prescription or medication order.

(6) An automated device that is operated at a location affiliated with a hospital, but not at the same physical address as the

pharmacy, that is owned and operated by the hospital, must comply with section 17760 of the code, MCL 333.17760.

(7) Records and electronic data kept by automated devices must meet all of the following requirements:

(a) All events involving access to the contents of the automated devices must be recorded electronically.

(b) Records must be maintained for 5 years by the pharmacy or dispensing prescriber and must be retrievable on demand for

review by an agent of the board. The records must include all of the following information:

(i) The unique identifier of the automated device accessed.

(ii) Identification of the individual accessing the automated device.

(iii) The type of transaction.

(iv) The name, strength, dosage form, quantity, and name of the manufacturer of the drug accessed.

(v) The name of the patient for whom the drug was ordered.

(vi) Identification of the pharmacist responsible for the accuracy of the medications to be stocked or restocked in the

automated device.

(8) Policy and procedures for the use of the automated device must include a requirement for pharmacist review of the

prescription or medication order before system profiling or removal of any medication from the system for immediate patient

administration. This subrule does not apply to the following situations:

(a) The system is being used as an after-hours cabinet for medication dispensing in the absence of a pharmacist as provided

in R 338.486(4)(j).

(b) The system is being used in place of an emergency kit as provided in R 338.486(4)(c).

(c) The system is being accessed to remove medication required to treat the emergent needs of a patient as provided in R

338.486(4)(c). A sufficient quantity to meet the emergent needs of the patient may be removed until a pharmacist is available

to review the medication order.

(d) In each of the situations specified in subdivisions (a) to (c) of this subrule, a pharmacist shall review the orders and

authorize any further dispensing within 48 hours

(e) The automated device is located in a dispensing prescriber's office.

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(9) A copy of all policies and procedures related to the use of an automated device must be maintained at the pharmacy

responsible for the device's specific location or at the dispensing prescriber's office and be available for review by an agent of

the board.

Board Response

(1): The Board does not agree with the comment to change the definition of “automated device” as the definition

of automated device is from the Code.

(2): The Board agrees with the comment to add the language “a pharmacy, or at the same physical address as the

pharmacy provided that the location of the device is owned and operated by the same legal entity as the

pharmacy.”

(3): The Board does not agree with the comment from Baran as this is already addressed in the controlled

substances rules but does agree with the comment from Roath as this is current practice with a change of the

term “patient” to “ultimate user.”

(4): The Board does not agree with the comment as the purpose of the provision is to state when a pharmacy can

own a device at a dispensing prescriber’s office. A reference to (2)(h) should be added here.

(5): The Board agrees with the comment to delete the reference to R 338.3154. The comment from MPA is

withdrawn.

(7): The Board agrees with the comments to provision (7).

Rule 338.589

Rule Numbers

Section (4)(d)

Professional responsibility; “caregiver” defined.

Commenter

Comment

Carlson/MHA

A requirement to document the consultation (or the reason why consultation was not completed)

should be included. There are a number of reasons for this … not the least of which is to protect the

pharmacist from liability should a patient claim he/she was not warned as required by this rule.

There is no longer an exception in R 338.486(3).

Section (5)

Baran/Ferris

Rules Committee (4)(d): The Rules Committee does not agree with the comment to add a requirement not currently required by the Code.

Response

(5): The Rules Committee does not agree with the comment that there is no longer an exception in R 338.486. However,

as there are multiple exceptions in this rule the reference to subsection (3) will be deleted.

R 338.589 Professional responsibility; “caregiver” defined.

Rule 89. (1) A pharmacist has a professional responsibility for the strength, quality, purity, and the labeling of all drugs and

devices dispensed under a prescription. In discharging this responsibility, a pharmacist shall utilize only those drugs and

59

devices that are obtained from manufacturers and wholesale distributors licensed under section 17748 of the code, MCL

333.17748, or from other lawful channels of distribution.

(2) A pharmacist shall not fill a prescription order if, in the pharmacist's professional judgment, any of the following

provisions apply:

(a) The prescription appears to be improperly written.

(b) The prescription is susceptible to more than 1 interpretation.

(c) The pharmacist has reason to believe that the prescription could cause harm to the patient.

(d) The pharmacist has reason to believe that the prescription will be used for other than legitimate medical purposes.

(3) A prescription drug must be dispensed only when the pharmacy is open and under the personal charge of a pharmacist.

(4) To encourage intended, positive patient outcomes, a pharmacist shall communicate to the patient, or the patient’s

caregiver, necessary and appropriate information regarding safe and effective medication use at the time a prescription is

dispensed. As used in this subrule, "caregiver" means the parent, guardian, or other individual who has assumed

responsibility for providing a patient’s care. All of the following provisions apply to communicating medication safety and

effectiveness information:

(a) The information must be communicated orally and in person, except when the patient or patient’s caregiver is not at the

pharmacy or when a specific communication barrier prohibits oral communication. In either situation, providing printed or

electronic/digital material designed to help the patient use the medication safely and effectively satisfies the requirements of

this subrule.

(b) The information must be provided with each prescription for a drug not previously prescribed for the patient.

(c) If the pharmacist deems it appropriate, the information must be provided with prescription refills.

(d) The information must be provided if requested by the patient or patient’s caregiver or agent for any prescription

dispensed by the pharmacy. This subrule does not require that a pharmacist provide consultation if a patient or a patient’s

caregiver refuses consultation.

This subrule does not apply to prescriptions dispensed for administration to a patient while the patient is in a medical

institution.

(5) Pharmacist delegation of acts, tasks, or functions shall be in compliance with section 16215 of the code, MCL 333.16215,

and under the personal charge of the delegating pharmacist, except as provided in R 338.486(3). A pharmacist who delegates

acts, tasks, or functions to a licensed or unlicensed person shall do all of the following:

(a) Determine the knowledge and skill required to safely and competently complete the specific act, task, or function to be

delegated.

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(b) Before delegating an act, task, or function, make a determination that the delegate has the necessary knowledge and skills

to safely and competently complete the act, task, or function.

(c) Provide written procedures or protocols, or both, to be followed by the delegatee in the performance of the delegated act,

task, or function.

(d) Supervise and evaluate the performance of the delegatee.

(e) Provide remediation of the performance of the delegatee if indicated.

(6) A delegating pharmacist shall bear the ultimate responsibility for the performance of delegated acts, tasks, and functions

performed by the delegatee within the scope of the delegation.

Board Response

(4)(d): The Board does not agree with the comment to add a requirement not currently required by the Code.

(5): The Board does not agree with the comment that there is no longer an exception in R 338.486. However, as

there are multiple exceptions in this rule the reference to subsection (3) will be deleted.

Rule 338.590

Rule Numbers

Section (11)

Hospice emergency drug box.

Commenter

Sapita/MPA

Comment

After “prescriptions” add issued by an appropriate prescriber” and remove “of the attending

physician.

Rules Committee (11): The Rules Committee agrees with the comment to update the language.

Response

R 338.590 Hospice emergency drug box.

Rule 90. (1) A pharmacy that establishes a medication box exchange program for hospice emergency care services rendered

in patients' homes pursuant to the provisions of section 17746 of the code, MCL 333.17746, shall establish drug boxes that are

in compliance with this rule. Before providing drug boxes for a hospice emergency care system, the pharmacist in charge shall

ensure that the hospice has developed policies and procedures that require all of the following:

(a) Maintenance by the hospice of a drug box exchange log that accounts for the hospice's receipt of the boxes from the

pharmacy, assignment of the boxes to registered nurses or physicians' assistants, and return of the boxes to the pharmacy for

restocking.

(b) A procedure to ensure that the drug boxes are inspected at least weekly to determine if they have expired or have been

opened.

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(c) Procedures for the storage and control of a drug box while it is assigned to, and being used by, the prescriber, a registered

nurse, or a physician's assistant.

(d) A procedure for implementing the hospice medical director's responsibility for ensuring that prescriptions for drugs

removed from the drug boxes are obtained from an appropriate prescriber.

(2) A pharmacy shall stock drug boxes for a hospice emergency care system in accordance with the policies and procedures

developed by the hospice and approved by the hospice medical director.

(3) The drugs contained in each drug box must be listed inside the front cover of the box. Each box must be equipped with

only 1 nonreusable, tamper-evident seal or sealing system which is a color that designates that the box has not been opened

and several nonreusable, tamper-evident seals or sealing systems which are a different color that designates that the box has

been opened.

(4) A drug box must be numbered. A permanent record of all drug boxes must be maintained at the pharmacy.

(5) A label that contains all of the following information must be attached to the drug box so that it is visible from the outside

of the box:

(a) The name and address of the pharmacy.

(b) The name and address of the hospice.

(c) The name of the pharmacist who last inspected and restocked the drug box.

(d) The date the drug box was last restocked.

(e) The date on which the drug box must be returned to the pharmacy for the replacement of expired drugs.

(f) The number of the drug box.

(6) After the drug box has been stocked and labeled, the pharmacist shall seal it with the nonreusable, tamper-evident seal or

sealing system which is the color that designates that the box has not been opened.

(7) A drug box must be kept in a substantially constructed, securely locked storage compartment when not under the direct

control of the pharmacist, prescriber, registered nurse, or physician's assistant. The box must be stored under conditions that

will maintain the stability, integrity, and effectiveness of the drugs. Access to the storage compartment and to the drug box

must be limited to individuals who are authorized to stock the drug box or to dispense drugs from the drug box on the order of

an appropriate prescriber.

(8) The drug box must remain sealed at all times, except when in use. All drugs removed from the box must be recorded on a

medication use form. After completing the form, the physician, registered nurse or physician's assistant who removed the drug

must place the form in the drug box and seal the box with a nonreusable, tamper-evident seal or sealing system which is a

color that designates that the box has been opened.

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(9) Each drug box under the control of the pharmacy must be examined at least weekly to ensure that the seal which

designates that the box has not been opened is still intact and the expiration date has not been exceeded. If the expiration date

has been exceeded or the box has been opened, the box must be returned to the pharmacy. The written prescription for all

drugs that have been administered from the drug box must accompany the drug box when it is returned to the pharmacy after

opening.

(10) The pharmacy shall maintain a permanent record of drug box exchanges on a drug box exchange log. The record must

contain all of the following information:

(a) The number of the box.

(b) The name of the hospice to which the box is released.

(c) The date the box is released to the hospice.

(d) The name and signature of the pharmacist who releases the box to the hospice.

(e) The expiration date assigned.

(f) The date the box is returned to the pharmacy for restocking.

(g) The name and signature of the pharmacist who received the box for restocking.

(11) Upon return of the drug box to the pharmacy, the pharmacist shall reconcile the drugs dispensed from the drug box with

the prescriptions of the attending physician appropriate prescriber or medical director of the hospice. The pharmacist shall

note that the prescriptions were dispensed from the hospice drug box on the back of the prescriptions. The prescriptions must

be filed in the same manner as other prescriptions are maintained at the pharmacy.

Board Response

(11): The Board agrees with the comment to update the language.

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