Wednesday, March 16, 2016

Missouri Law Prohibits office use compounding unless the pharmacy/pharmacist is registered as an FDA drug manufacturer or drug outsourcing facility.

COMPOUNDING FOR OFFICE USE Pharmacies may not sell or dispense sterile compounds to practitioners or other prescribers for office use. [20 CSR 2220-2.400(1), (12)]. This includes hospitals, surgery centers, etc. Once again, a patient specific prescription is required prior to dispensing. Pharmacies/pharmacists may only compound for office use if the pharmacy/pharmacist is registered as an FDA drug manufacturer or drug outsourcing facility. In 2013, the federal Drug Quality and Security Act (DQSA) was enacted which recognized and established requirements for “drug outsourcing facilities” and references compounding for office use. FDA registered drug outsourcers/manufacturers may only compound for office use in Missouri if the outsourcer is licensed with the Board as a drug distributor.

quoted from here 

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