503B Outsourcing Facilities -- Possible Suppliers to Pharmacies?
IACP has received many questions from members and non-members about whether or not they could purchase compounded sterile medications from an FDA-registered outsourcing facility to then dispense to patients in their practice. In other words, compounding pharmacies and even regular non-compounding community pharmacies may see an opportunity to expand the scope of their services if they could obtain compounded sterile drugs without doing the compounding themselves. But can that happen?
Even though 503B facilities are prohibited from distributed medications to purchasers who will then resell them (e.g., a wholesaler), the Drug Quality and Security Act (DQSA) specifically permits the purchase of a 503B facility's preparations for the purpose of administering to a patient or dispensing pursuant to a patient specific prescription.
IACP Member Call to Action: Your Academy is Seeking Information
IACP Members: Do you currently hold a manufacturer/wholesaler/distributor permit through the DEA for controlled substances? IACP is aware of legislation that could positively or negatively impact our membership. IACP's Board currently is assessing its membership's needs to determine the extent to which it will. Your feedback will assist us in making this strategic decision. Please email firstname.lastname@example.org with the information by close of business, Tuesday, February 25th.