Requirement
503A Pharmacies banned from compounding for docs without prescription
The US Food and Drug Administration (FDA) says compounding pharmacies must not manufacture medicines for hospitals and doctors’ offices, except for named patients.
Impact Statement
With the publication of the final guidance, “Prescription Requirement Under Section 503A of the Federal Food, Drug and Cosmetic Act,” the FDA has now clearly stated, in final guidance, it believes the provision of compounded drug products via a drug order or non-patient-specific prescription to physician offices or other health care settings is prohibited under Section 503A. If your pharmacy participates in “office use” compounding or compounding for office administration without receiving a patient specific prescription, the FDA will assert your pharmacy is in violation of Section 503A and loses the exemptions provided within the law (compliance with cGMP, requirements for the New Drug Application process and proper labeling requirements).
Supporting Arguments
Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Office of Compliance/OUDLC December 2016 Compounding and Related Documents
