The proposed rules protect the health, safety, and welfare of Michigan citizens while promoting a regulatory
environment in Michigan that is the least burdensome alternative for those required to comply, as the rules do the
following: make preceptor affidavits less subjective by requiring actual internship hours instead of comments on the
ability to practice; allow an applicant who has failed the NAPLEX or the MPJE to review the material in an
preparation course or with an instructor instead of completing courses in an education program; clarify that an
applicant who has completed the FPGEC certification has met the English proficiency requirement; allow an applicant
for licensure by endorsement to obtain a license in this state if he or she either holds a license in another state or holds
a license in Canada and meets additional requirements; require an applicant for relicensure to submit discipline that
occurs between the time he or she applies and licensure to the department; establish the requirements for a remote
pharmacy license; provide a process to receive a waiver from the 10-mile requirement between a remote pharmacy
and another pharmacy; require an in-state and out-of-state pharmacy that will provide sterile compounding in this state
to submit an onsite physical inspection and report completed no more than 18 months before the application; clarify
that a pharmacy that starts or resumes sterile compounding must apply to the department and submit the required
inspection report; require a pharmacy, manufacturer, wholesale distributor, and wholesale distributor-broker that is
closing to maintain records for the same amount of time that records would have been maintained if the pharmacy
remained open; clarify the process for renewal versus relicensure for a pharmacy, manufacturer, wholesale distributor,
and wholesale distributor-broker; add the requirements for a facility manager if a manufacturer chooses to use a
facility manager instead of a pharmacist in charge; adopt the federal exclusions to the definition of wholesale
distribution to ensure that the rules do not require a pharmacy to obtain a license as a wholesale distributor if the same
activities would not be considered wholesale distribution under the federal law; add the licensure and record keeping
requirements for a wholesale distributor-broker; reduce the time from 3 years to 2 years before a prescription may be
electronically duplicated; provide the requirements for electronic transmission of prescriptions; provide the process for
a waiver from the mandate to electronically transmit a prescription after a specific date; and clarify that if final
product verification is delegated, then both the pharmacist and technician must record their initials.
Promulgation of rules related to licensure of pharmacists, interns, preceptors, pharmacies, manufacturers, wholesale
distributors, and wholesale distributor-brokers are required by statute. These rules provide a regulatory framework for
the practice of pharmacy. The proposed rules will clarify what is required for pharmacies that intend to compound and
handle sterile pharmaceuticals or practice in a remote pharmacy. The proposed rules adopt the sterile compounding
standards of the USP to attempt to avoid mistakes in sterile compounding that have harmed the public in the past. The
proposed rules will also provide the requirements for the legislative mandate for the electronic transmission of
prescriptions and the waiver process in limited circumstances. The proposed rules regulate the practice of pharmacy to
protect the public. The proposed rules will protect the welfare of Michigan citizens by providing greater clarity to
licensees, which will aid in compliance with requirements under the rules.
9. Describe any rules in the affected rule set that are obsolete or unnecessary and can be rescinded.
There are no rules being rescinded in this proposed rule set.
Fiscal Impact on the Agency
Fiscal impact is an increase or decrease in expenditures from the current level of expenditures, i.e. hiring additional staff,
higher contract costs, programming costs, changes in reimbursements rates, etc. over and above what is currently
expended for that function. It does not include more intangible costs for benefits, such as opportunity costs, the value of
time saved or lost, etc., unless those issues result in a measurable impact on expenditures.
10. Please provide the fiscal impact on the agency (an estimate of the cost of rule imposition or potential savings
for the agency promulgating the rule).
The proposed rules will provide a licensure process for remote pharmacies and wholesale distributor-brokers, a
waiver process for remote pharmacies, and a waiver process for electronic transmission of prescriptions. The
department expects the proposed rules may result in additional administrative costs, however, there will also be
licensure fees associated with the licensure process. The department does not expect the implementation of the
proposed rules to result in additional savings for the department.
11. Describe whether or not an agency appropriation has been made or a funding source provided for any
expenditures associated with the proposed rules.