While the Drug Quality and Security Act (DQSA), which created significant implications for compounders by effectively reinstating Section 503A the Federal Food Drug and Cosmetic Act (FD&C Act), was signed in November 2013, its full effect has not been entirely felt by traditional compounding pharmacies since specific provisions of Section 503 still require rulemaking or other action by the FDA. Nearly two years later, the FDA’s intentions with regards to enforcement of certain provisions remains unclear.
In a recently published Interim Guidance, the FDA has endeavored to clarify some of these lingering uncertainties for Section 503A compounders. With regards to provisions that still require rulemaking and action by the FDA, the FDA has offered the following guidance:
- Withdrawn or Removed List: FDA stated its intention to continually update the list periodically and expects compounders to comply with the list as it currently exists and with final updates.
- Bulk Drug Substances List: FDA has issued a separate Interim Policy which allows 503A compounders to compound using bulk substances contained on an interim list developed by the FDA based on prior nominations through the Federal Registrar until the final list is published as a final rule.
- Demonstrable Difficulties for Compounding: FDA has confirmed that this provision is not enforceable until the FDA promulgates an implementing regulation.
- Memorandum of Understanding (MOU): FDA has indicated that it does not intend to enforce the 5% limitation on interstate distribution until after FDA has finalized an MOU and made it available to the states for their consideration and signature. The Federal Registrar notice which will announce the availability of the draft MOU will specify a time period during with the MOU will be made available to the states to sign. After this time period expires, FDA intends to enforce the 5% limit on states that have not signed the MOU.
In the Interim Guidance, the FDA also addressed its intentions with regards to enforcement action against Section 503A compounders. The Guidance emphasized that compounders may be subject to enforcement action by the FDA ranging from warning letters to criminal prosecution for violations of the FD&C Act such as:
- Distributing contaminated drug products
- Compounding a drug which purports to be recognized in an official compendium but has strength, quality or purity which falls below the compendium
- Compounding a drug product whose strength differs from, and quality or purity falls below, that which it purports to have
- Packaging and labeling a drug product that purports to be a drug recognized in an official compendium in a manner that differs from the compendium
- Using false or misleading labeling, advertising or promotion
The Interim Guidance reiterated that a compounder’s preparation and distribution of drug products that do not meet the conditions of Section 503A could lead to the compounder being charged with producing adulterated drugs, producing unapproved new drugs, and misbranding. While the FDA employs a risk-based enforcement approach, the FDA emphasizes that it does not need to identify a particular safety problem before pursing enforcement action. The frequency of FDA enforcement action against compounding pharmacies continues to rise. Contact Frier Levitt to ensure your pharmacy’s practices are compliant with Section 503A.