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Compounding Medication Regulations

What are compounding pharmacies banned from doing?

Other proscriptions may apply, but here are some of compounding medication regulations, which state what compounding pharmacies cannot do.

  • Compounding pharmacies cannot make pharmaceuticals without a prescription order from a licensed practitioner with prescriptive rights (medical doctor, osteopath, dentist, podiatrist, veterinarian, et al.)
  • Compounding pharmacies cannot duplicate prescription or over-the-counter pharmaceuticals that are readily available on the commercial market. (Drugs that are on temporary back-order or manufacturer discontinued are allowed for compounding, however.)
  • Compounding pharmacies cannot compound medications for food or food-producing animals.
  • Compounding pharmacies cannot make claims of efficacy about their compounds.
  • Compounding pharmacies cannot make customized veterinary drugs containing trilostane or pergolide unless they use the commercially available form of these pharmaceuticals as the source of the active ingredient for said compounds.
  • Compounding pharmacies cannot claim that their compounds are FDA-approved drugs.
  • Compounding pharmacies cannot dispense their compounds in states where their pharmacies are not licensed (unless the state has no licensing regulations for out-of-state pharmacies that dispense within their borders).
  • Compounding pharmacies cannot operate like manufacturers. If engaging in manufacturing (making drugs without a specific prescription order), then the pharmacy comes under the sole regulatory purview of FDA and not of the state board of pharmacy.
  • Compounding pharmacies cannot compound drugs that were withdrawn or removed from the market for safety reasons.
  • Compounding pharmacies cannot use ingredients sourced from facilities that are not FDA approved.

Compounding pharmacies cannot simply abide by federal compounding medication regulations; they must also comply with the state board of pharmacy regulations in their state(s) of operation.

To read about more common compounding pharmacy questions, please refer to our FAQ page.