8. Please cite the specific promulgation authority for the rules (i.e. department director,
commission, board, etc.).
MCL 333.16141 authorized the Department to promulgate rules to promote the effective and
consistent administration of Article 15 of the Public Health Code. MCL 333.16145 authorizes a
Board to promulgate rules necessary or appropriate to fulfill its functions as prescribed in Article
15. MCL 333.17742a authorizes the Department, in consultation with the Board, to establish
requirements for licensure for remote pharmacies. MCL 333.17748a authorizes the Department, in
consultation with the Board, to promulgate rules regarding conditions and facilities for the
compounding of nonsterile and sterile pharmaceuticals. MCL 333.17748e authorizes the
Department, in consultation with the Board, to establish requirements for licensure as a wholesale
distributor-broker. MCL 333.17754a authorizes the Department to establish by rule the
requirements for obtaining a waiver from electronically transmitting a prescription, as well
authorizing the Department, in consultation with the Board, to promulgate rules to implement
MCL 333.17754a; MCL 333.17767 authorizes the Board to promulgate rules necessary or
appropriate to the licensing of pharmacists, drugs, dispensers, manufacturers, wholesale
distributors, and wholesale distributor-brokers.
A. Please list all applicable statutory references (MCLs, Executive Orders, etc.).
MCL 333.16141; MCL 333.16145; MCL 333.16148; MCL 333.16201; MCL 333.16204; MCL
333.16204e; MCL 333.16205; MCL 333.16215; MCL 333.16287; MCL 333.17707; MCL
333.17721; MCL 333.17731; MCL 333.17737; MCL 333.17739; MCL 333.17742a; MCL
333.17742b; MCL 333.17746; MCL 333.17748a; MCL 333.17748b; MCL 333.17748e; MCL
333.17754a; MCL 333.17757; MCL 333.17767; MCL 333.17775; Executive Reorganization
Order No. 1991-9, MCL 338.3501; Executive Reorganization Order No. 1996-2, MCL 445.2001;
Executive Reorganization Order No. 2003-1, MCL 445.2011, and Executive Reorganization Order
No. 2011-4, MCL 445.2030.
B. Are the rules mandated by any applicable constitutional or statutory provision? If so, please
The proposed rules are required by sections 16287, 17722, 17731, 17737, 17742a, 17748e, and
17754a of the Code, MCL 333.16287, MCL 333.17722, MCL 333.17731, MCL 333.17737, MCL
333.17742a, MCL 333.17748e, and MCL 333.17754a. The rules are not federally mandated.
9. Please describe the extent to which the rules conflict with or duplicate similar rules,
compliance requirements, or other standards adopted at the state, regional, or federal level.
There are no other laws, rules or other legal requirements that conflict with the proposed rules.
Each state establishes its own requirements with respect to the licensing requirements of
pharmacists, pharmacies, manufacturers, and wholesale distributors. In addition to state laws and
rules, federal laws regulate the practice of pharmacy with respect to controlled substances and
chemicals used in the manufacture of controlled substances.
The proposed rules are being modified pursuant to additions to the Code.
10. Is the subject matter of the rules currently contained in any guideline, handbook, manual,
instructional bulletin, form with instructions, or operational memoranda?
No. The subject matter of these rules is not currently contained in any guideline, handbook,
manual, instructional bulletin, form with instructions, or operational memoranda.
11. Are the rules listed on the department’s annual regulatory plan as rules to be processed
for the current year?