The regulator published five draft documents as part of a larger series of policy documents concerning the FDA’s oversight of drugs produced by state-licensed pharmacies, federal facilities and outsourcing facilities.
With these documents, the FDA covered:
- Outsourcing facility registration, providing information about the regulatory impact of registering with the regulator as an outsourcing facility after confusion was expressed about whether entities that take part in a variety of activities should register. The FDA recommends not registering if a facility doesn’t intend to compound all drugs at the facility in accordance with section 503B of the FD&C Act.
- Drug repackaging, explaining how it will address repackaging by state-licensed pharmacies, federal facilities or outsourcing facilities, and describing when it won’t take action for violations when such entities repackage drug products.
- Mixing, diluting and repackaging biological products, describing when it won’t take action for violations of certain Public Health Service Act and FD&C Act sections when state-licensed pharmacies, federal facilities or outsourcing facilities mix, dilute or repackage specific biological products without an approved biological license application, or when prescription sets of allergenic extracts are prepared without one. Because there are instances when biological products need to be handled in ways that aren’t covered in approved labeling for the product, the FDA put out this guidance to explain when it won’t take action.
- Outsourcing facility adverse event reporting, explaining adverse event reporting for outsourcing facilities. The document requires the reporting of all serious, unexpected adverse drug experiences related to the use of a compounded product, but recommends the broader reporting of all serious adverse drug experiences associated with a product.
- Draft Memorandum of Understanding with the states, describing the responsibilities of a participating state in probing and responding to complaints about compounded human drug products distributed outside the state, and in dealing with the interstate distribution of “inordinate amounts” of compounded human drug products.