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Regulatory News | 15 April 2016 | By Zachary Brennan
On Friday, the US Food and Drug Administration (FDA) released three draft guidance documents for drug compounders.
The guidance describes FDA’s interpretation of the prescription requirement in section 503A of the Food Drugs & Cosmetics Act (FD&C Act), how the agency intends to apply such a requirement to compounding for hospitals or health system pharmacies, and the definition of the term “facility," in reference to section 503B of the FD&C Act.
The draft guidance documents include:
Each draft guidance document is available for public comment for 90 days.
Office Use Compounding
Lee Rosebush, a partner with the FDA practice the law firm BakerHostetler, told Focus that the guidance “is going to hurt traditional compounding pharmacies, as it is clear they are not going to be able to do office use compounding.”
FDA has also expanded the role of a 503B facility, particularly into the hospital market, he said.
The draft guidance on prescription requirements notes: “Hospitals, clinics, and health care practitioners can obtain non-patient-specific compounded drug products from outsourcing facilities registered under section 503B. Outsourcing facilities, which are subject to CGMP requirements, FDA inspections according to a risk-based schedule, specific adverse event reporting requirements, and other conditions that provide greater assurance of the quality of their compounded drug products, may, but need not, obtain prescriptions for identified individual patients prior to distribution of compounded drug products.”
Rosebush noted the push to get compounders to register as 503B facilities: ”With the increase in compounding, there has been an increase in office use compounding (otherwise known as compounding for use in a prescriber's office). With the passage of the DQSA [Drug Quality Security Act], there has been a push to move office use compounding to 503B facilities (as they follow cGMP [current good manufacturing practices] and are FDA regulated) from the traditional 503A pharmacies.”
He also explained part of the impact on hospital pharmacies as “a pharmacy in a hospital cannot compound medication and send to another hospital in the same system unless the hospital pharmacy is registered as a 503B facility with the FDA.”
New Draft Guidance on Drug Compounders
Tags: drug compounding, hospital pharmacists