A recent observation: Some individuals have stated that they thought that if an   ingredient or product formulation was in the USP-NF, that it was FDA-approved. This is not always the case. For example, dietary supplement ingredients listed in the USP-NF do not have FDA approval. Grandfathered ingredients do not necessarily have FDA reviews and approval. Compounded formulations are not FDA-approved, though they contain ingredients that are in FDA-approved products or USP-NF monographed ingredients.

 Just a reminder, USP-NF grade ingredients are to be used in compounding when available. However, many commercially available drugs do not have USP-NF monographs available. USP is working on increasing the number of monographs in the book; but, it is a long process. In the meantime, if an ingredient is not available as a USP-NF ingredient, the highest quality reasonably available should be used, based on professional judgment.

Congress recently finalized the 2005 omnibus appropriations bill and conference report. Compounders were successful in changing disturbing language on human compounding in the final appropriations report.

SBA Replies to Pharmacists� Concerns about FDA Veterinary Policies In letters dated November 18, 2004, the Small Business Administration (SBA) responded to IACP members who filed complaints with SBA regarding concerns with the FDA CPG on veterinary compounding. For more information on these topics, please visit http://www.iacprx.org/elinks/11_23_04.html.

This week on IJPC�s listserv, pharmacists discussed:

• Progesterone levels in saliva and progesterone and E2 ratios.
• A formula for Boyette's Solution.
• A formula Celecoxib suspension.
• That Folic Acid injection is on national shortage.

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