503A Pharmacy vs. 503B Outsourcing Facility
| 503A pharmacy | 503B outsourcing facility |
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| Statute | 21 U.S.C. § 353a | 21 U.S.C. § 353b |
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| Prescription | Required for an identified individual patient; limited anticipatory compounding | Not required; may compound in bulk |
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| Primary regulator | State board of pharmacy, with FDA oversight | FDA, with state licensing |
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| Manufacturing standard | USP compounding standards | Current good manufacturing practice (CGMP) |
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| Registration | State license | Registers with FDA; semiannual product reporting |
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| Bulk drug substances | USP or NF monograph, component of an approved drug, or on FDA's 503A bulks list | On FDA's 503B bulks list or used to address a drug on the shortage list |
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| Copies of approved drugs | May not compound regularly or in inordinate amounts | May not compound drugs that are essentially copies of approved drugs |
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| Resale | Dispensed to the patient | May not be wholesaled by others |
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Where Compounding Pharmacy Cases Come From
- GLP-1 compounding after the shortages ended. FDA declared the tirzepatide shortage resolved in December 2024 and the semaglutide shortage resolved in February 2025. Once a drug leaves the shortage list, compounding copies of it is sharply restricted, and "personalized" dosing or additives do not automatically cure the problem.
- Ineligible bulk substances. Several peptides used in wellness practice, including BPC-157, have been placed by FDA in Category 2 of its interim bulk substance list, reflecting significant safety concerns. Compounding from them invites FDA action.
- Office stock and missing prescriptions. 503A pharmacies that ship to clinics without patient-specific prescriptions, or fill prescriptions from prescribers who never evaluated the patient.
- Telehealth and marketing arrangements. Per-prescription payments to platforms, marketers, or prescribers can violate the federal Anti-Kickback Statute when a federal health program pays, and Florida's Patient Brokering Act (Fla. Stat. § 817.505) regardless of who pays.
- Sterile compounding failures. Contamination, failed environmental monitoring, and deficient cleanroom practices support adulteration charges based on insanitary conditions.
- Interstate shipping and licensing gaps. Shipping into states without the required nonresident license. Florida requires a nonresident sterile compounding permit for pharmacies that ship compounded sterile products into the state (Fla. Stat. § 465.0158).
What Is at Stake
Florida. Board of Pharmacy discipline and license action under the Florida Pharmacy Act (Chapter 465); enforcement under the Florida Drug and Cosmetic Act (Chapter 499); patient brokering under § 817.505 and kickbacks under § 456.054; Medicaid provider fraud under § 409.920 where Medicaid paid.
Federal. FDA warning letters, import alerts, seizures, and consent decrees; introduction of adulterated or misbranded drugs into interstate commerce (21 U.S.C. §§ 331, 333); conspiracy to defraud the United States (18 U.S.C. § 371); wire fraud (18 U.S.C. § 1343); and, when federal programs paid, healthcare fraud and Anti-Kickback charges (18 U.S.C. § 1347; 42 U.S.C. § 1320a-7b(b)), exclusion from Medicare and Medicaid, and False Claims Act liability.
Who We Represent
- 503A pharmacy owners and pharmacists-in-charge
- 503B outsourcing facility owners and quality leadership
- Physicians, nurse practitioners, and physician assistants who prescribe compounded drugs
- Telehealth platforms and management services organizations
- Med spas and weight-loss clinics that source compounded GLP-1s and peptides
- Investors and executives in compounding businesses
How We Help Before and After Enforcement
Before enforcement. We review your website, product listings, social media, prescription workflow, and partner arrangements, and flag the issues regulators and prosecutors look for first. We do not endorse products or tell you how to run your business; we tell you where the legal risk sits.
During an inspection or investigation. We prepare you for FDA and board inspections, manage Form 483 and warning letter responses, respond to subpoenas and civil investigative demands, and handle all contact with investigators.
If charges are possible. We assess personal exposure for owners and pharmacists, engage prosecutors before charging decisions are made, and defend the case if one is brought.
Who Handles Your Matter
Aaron M. Cohen has defended federal and state criminal cases for more than 30 years, including healthcare fraud, controlled substance, and regulatory prosecutions. The firm's peptide and compounding practice tracks FDA, DOJ, and state board enforcement as it happens and publishes that analysis in Justice Watch.
