Earlier this year, we focused one of our client alerts on a new Guidance issued by the Food and Drug Administration (FDA) concerning certain prescription requirements for compounding human drug products under section 503A of the Federal Food, Drug, and Cosmetic Act. See "FDA Issues Guidance on Prescription Requirement for Compounded Drugs".
Since the release of that Guidance, members of Congress have taken issue with the FDA's interpretation of section 503A and, in a letter signed by 65 members, asked FDA Commissioner Scott Gottlieb to rescind the Guidance. At the core of the dispute is the Guidance position that state-licensed pharmacies cannot compound medications pursuant to state pharmacy laws for administration to patients in office or clinical settings (i.e. "in-office compounding"). The language used by the members is quite strong:
"Compounding for office-use done pursuant to state pharmacy laws does not make a pharmacy a drug manufacturer, and Congress never intended for the FDA to assert regulatory authority over the traditional practice of pharmacy, which has always been regulated at the state level.
"The policies finalized in this GFI are contrary to the plain language of Section 503A as amended by the Drug Quality and Security Act (DQSA) and ignore clear, bipartisan, bicameral congressional intent expressed during passage of the bill. The FDA has unfortunately chosen to ignore broad and diverse stakeholder input, multiple congressional letters from both chambers, and clear directives in the House Report accompanying the FY2016 FDA appropriations legislation…."
The letter concludes by asking Commissioner Gottlieb to immediately rescind the Guidance and issue a proposed rule that conforms to the language and intent of the DQSA and allows for office-use compounding by state-licensed pharmacies where such is permitted under applicable state pharmacy laws.