Compound pharmacies are subject to FDA inspections; however, the standard for inspection differs depending on whether they are registered as an outsourcing facility (“503B”) or meet the 503A exemption from drug manufacturing regulations.
Compound pharmacies who compound for an identified individual patient and dispense upon receipt of a patient-specific prescription, are exempt from FDA registration, compliance with current Good Manufacturing Practices (CGMP), and labeling requirements, so long as they meet the 503A exemption requirement.
Generally, the FDA has limited interaction with these pharmacies; however, they will inspect these pharmacies if they receive a complaint or believe the pharmacy does not meet the 503A exemption.
Compound pharmacies registered as 503B outsourcing facilities are subject to FDA inspection on a risk-based schedule. Unlike 503A compounding pharmacies, these pharmacies must comply with CGMP regulations.
While compound pharmacies (not registered as outsourcing facilities) are exempt from CGMP regulations, this exemption rests on whether they can support each compound drug with a proper prescription for a specific patient. Compound pharmacies who fail to show the FDA investigator supporting prescriptions, will not be able to claim a 503A exemption, and will therefore be required to comply with CGMP and other regulations required of drug manufacturers.
Many compound pharmacies who believed they were exempted from CGMP, instead found themselves subject to discipline and enforcement action for non-compliance because their prescriptions did not meet the 503A exemption.
Common reasons for prescriptions failing the 503A exemption include:
- Compounding and dispensing without receipt of a prescription
- Compounding and dispensing without receipt of a prescription that identifies a specific patient
- Compounding before receipt of a prescription when there is no pharmacists-physician relationship for orders regarding a specific patient
- Compounds that deviate from the prescribed drug
- Drugs made in bulk without a prescription
- Compounding regular or inordinate amounts of drugs that are commercially available (compound pharmacies)
- Compounding commercially available products (outsourcing facilities)
- Compounding drugs that have been removed or withdrawn from the market by the FDA
Additionally, all compound pharmacies and manufacturers, regardless of 503A exemption status, are subject to FDA regulations regarding sanitary conditions and contamination. Several compound pharmacies and manufacturers have found themselves subject to enforcement action — including criminal action — for manufacturing contaminated drugs.