Pharmacy Law: Regulatory Developments Affecting Pharmacy Practice

The past few years have seen a number of legislative and regulatory changes at the federal level; both with the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA). This article will address key changes impacting pharmacy practice in the areas of compounding, drug supply chain security, biosimilars, and the regulation of controlled substances in order to prevent diversion and abuse.

The passage of the Drug Quality and Security Act of 2013 (DQSA) updates the Federal Food, Drug, and Cosmetic Act (FDCA) in the areas of human drug compounding and drug supply chain security. Previously, compounding was mostly regulated by individual states under section 503A of the FDCA. In the years to come, the FDA will continue to clarify regulations surrounding compounding and drug supply chain security.

The FDA has developed policy regarding biological medications, particularly around nearly identical biological products (biosimilars) and their therapeutic substitution. A new online publication called the “Purple Book” lists biological products, and specifies those that are biosimilar and/or interchangeable.

Regarding the DEA, a number of changes have occurred to
help address the national prescription drug abuse and diversion
epidemic. DEA rules regarding disposal of controlled substances,
and the rescheduling of hydrocodone combination products have
been finalized and implemented. In 2016, the Comprehensive Addictionand Recovery Act was passed, which includes a provision for partially filling Schedule II controlled substance prescriptions for up to 30 days from the date of the prescription.