In his bimonthly column for Pharmacy Times, Much health care attorney Ned Milenkovich discussed the regulatory status of peptide compounding as interest and popularity rise.
In his article, Milenkovich covers the U.S. Food and Drug Administration’s (FDA) Pharmacy Compounding Advisory Committee's (PCAC) consideration of seven peptide families for possible inclusion on the 503A bulks list. He highlights an important distinction: The PCAC only advises the FDA, and its recommendations are not binding. He goes on to analyze the weight those recommendations actually carry in the FDA's regulatory process.
The bottom line is that placement of a bulk drug substance on the 503A bulks list is not a confirmation of FDA approval of a compounded drug, and the most important thing pharmacists can do now is stay informed as the FDA’s review continues.
Co-chair of Much's Health Care group and a registered pharmacist, Milenkovich helps drug, pharmacy, and other health care clients meet the demands of federal and state regulators, strengthen their positions in a highly competitive marketplace, and resolve a broad range of commercial disputes.