As covered in our Town Hall teleconference
and in the story below, several regulations and requests for input were issued by the FDA on December 4. One of the most critical is the agency's request for a list of drugs for which APIs (Active Pharmaceutical Ingredients) are necessary for compounding preparations. As provided for within 503(a), a pharmacist or physician may compound medications for individual patients using an API only if that drug has a USP monograph, is a component of an FDA approved drug, or appears on a list of APIs reviewed and approved by the FDA's Pharmacy Compounding Advisory Committee and accepted by the Secretary of Health and Human Services.
IACP is assembling a list of APIs used regularly in compounding for which no USP monograph exists or is part of an FDA approved drug to submit on behalf of our members. We need your assistance in identifying as many of these as possible.
Please submit the following information for each API you use that falls into this category to us at iacpinfo@iacprx.org no later than January 15, 2014:
- Name of the API including the chemical name and common name
- Chemical grade, strength, quality and purity of the API
- Form of the API (powder, liquid, etc.)
- Whether a monograph in an ex-US pharmacopeia exists such as the British Pharmacopeia
- Common compounded dosage forms, strengths and route of administration for which the API is used
- Clinical data, studies, papers, references, etc. on how the compounded version of the API is used
- Stability data for the compounded preparations
The Academy will compile a formal dossier on each of these medicines you help identify for submission to the agency in time for its March 4, 2014 comment deadline.
quoted from here
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