Dispensing Compounded Drugs from a 503B Outsourcing Facility and the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act
This Briefing is brought to you by AHLA’s Life Sciences Practice Group.
- October 29, 2024
- Lee Rosebush , BakerHostetler
- Marc Wagner , BakerHostetler
The Federal Food, Drug and Cosmetic Act (FD&C Act) provides for a bifurcated compounding framework: Section 503A and Section 503B. Separating the types of compounders, quality standards, federal oversight, and activities each compounder may perform is a complementary system because patients should have access to compounded drug products when necessary. As a policy consideration, drugs approved by the Food and Drug Administration (FDA) should be used whenever available and appropriate for a given patient based on a prescriber’s clinical judgment. However, there are many scenarios where a compounded drug may be necessary—for example, if the FDA-approved drug is in shortage and therefore unavailable, as patients benefit from compounded drugs over no drug at all. Additionally, patients may have allergies to certain components found in FDA-approved drugs and the compounder can formulate a drug product that does not contain the allergen. Patients may also need a different dosage form or strength than is available in an FDA-approved drug product. These are just three examples of when a compounded drug may be indicated as determined by a prescriber.
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