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The proposed rules are required by sections 16148, 16204, 16287, 17724, 17724a, 17731, 17737,
17744f, 17748e, 17754a of the Public Health Code, MCL 333.16148, MCL 333.16204, MCL
333.16287, MCL 333.17724, MCL 333.17724a, MCL 333.17731, MCL 333.17737, MCL
333.17744f, MCL 333.17748e, MCL 333.17754a.
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.
The Drug Supply Chain Security Act, (DSCSA) Public Law 113-54 and corresponding federal
regulations include requirements to develop and enhance drug supply chain security. They
establish a federal system for tracing prescription drug products through the pharmaceutical
distribution supply chain and include product tracing requirements for entities in the drug supply
chain, including manufacturers, repackagers, wholesale drug distributors, and pharmacies. They
also require the Food and Drug Administration (FDA) to establish federal standards for licensing
of wholesale drug distributors and third-party logistics providers. States may not regulate tracing
that is inconsistent with, more stringent than, or in addition to the federal requirements. States are
also preempted from establishing licensure requirements that are inconsistent with or below the
minimum standards established by federal law for wholesale distributors and third-party logistics
providers. The DSCSA and federal regulations require a wholesale drug distributor and third-party
logistics provider to maintain licensure in the state from which the drug is distributed and in most
cases the state into which the drug is distributed if those states have a licensure process. State
licensure information including significant discipline must be reported to the FDA on an annual
basis.
The rules adopt the pharmaceutical compounding standards of the United States Pharmacopeia
(USP), published by the United States Pharmacopeial Convention, and the regulations regarding
good manufacturing practices for finished pharmaceuticals set forth in 21 CFR sections 211.1 to
211.208 (1978). Some aspects of the practice of pharmacy, such as the labeling of prescription
drugs, are regulated by the Federal Food, Drug, and Cosmetic Act of 2016, 21 USC sections 351
to 399g and have been adopted by the rules.
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for
Patients and Communities (SUPPORT) Act and corresponding Code of Federal Regulations, 42
CFR 423, require electronic prescribing under Medicare Part D for Schedule II to V controlled
substances and provide for exceptions to this requirement. Section 17754a of the Public Health
Code, MCL 333.17754a, requires the Department to establish by rule the requirements for
obtaining a waiver from electronically transmitting all prescriptions, including controlled
substances. The rules provide for a waiver from electronic prescribing in certain circumstances.
Most, but not all of the circumstances are consistent with the SUPPORT Act.
Under the Controlled Substances Act, (CSA), 21 USC 801 et seq., the federal government
regulates the practice of pharmacy with respect to controlled substances and chemicals used in the
manufacture of controlled substances and requires pharmacies to register or self-certify with the
Drug Enforcement Administration (DEA). A pharmacy must maintain a state license to obtain a
DEA registration.
Taking into consideration the federal laws and regulations referenced above, each state establishes
its own requirements with respect to the licensing requirements of pharmacists, pharmacies,
manufacturers of prescription drugs and devices (manufacturer), wholesale distributors of
prescription drugs and devices (wholesale distributor), and wholesale distributor-brokers of
prescription drugs and devices (wholesale distributor-broker). There are no other known laws,
rules or other legal requirements that conflict with or duplicate the proposed rules.
MCL 24.239