Compounding: Section 503A Changes
The regulatory landscape for pharmacy compounding has changed immensely since the passage of the Drug Quality and Security Act (DQSA) in November 2013.
Historically, the Food and Drug Administration (FDA) has not strictly enforced pharmacy compounding under the FDA Modernization Act of 1997. However, the passage of the DQSA, which updated Section 503A of the Federal Food, Drug and Cosmetic Act (FDCA) and created a new category of outsourcing facilities under Section 503B of the FDCA, has dramatically altered the regulatory landscape such that the FDA is now taking a more active role in enforcing a variety of compounding violations.
Section 503A has generally applied to traditional compounding operations, which operate in response to patient-specific prescriptions, or in some instances, in anticipation of prescriptions based on prior prescribing histories. The minor changes addressed by the DQSA include:
- Removing the requirement that a pharmacy, licensed pharmacist, or licensed physician can not advertise or promote the compounding of any drug, class of drug or type of drug;
- Removing requirement that a prescription be unsolicited from a compounding pharmacy
- Not requiring a licensed pharmacist, physician or other licensed prescriber who compounds a drug based on a patient specific prescription to:
- Meet current Good Manufacturer Practices (cGMP);
- Meet manufacturer standards for adequate directions for use on a label, and
- File a new drug application.
It remains crucial that all traditional pharmacy operations, specifically hospitals and health systems, and all voluntarily registered outsourcing facilities remain up-to-date on all changes related to the DQSA and Sections 503A and 503B as the regulatory landscape continues to rapidly evolve.
Baer Law will continue to monitor these changes and keep compounding pharmacies abreast of any rule changes or updates. Contact Baer Law today with questions.