The Alliance for Pharmacy Compounding ("APC") issued a statement March 1, 2024 reaffirming APC’s position that many drugs commonly used in “peptide therapy” are not legal for use in compounded drugs. The statement is titled "UNDERSTANDING THE LAW AND REGULATION GOVERNING PEPTIDE PRODUCTS." APC is the leading voice for the pharmaceutical compounding community. This statement makes clear the Alliance, and the collective industry’s position, that peptide drugs on Category 2 of the Food and Drug Administration’s (FDA) Bulk Substances List are not allowed in compounded drugs.

In September 2023, FDA added several peptides to Category2 of its 503A Interim Bulks List. Substances listed in Category 2 are not to be used as active pharmaceutical ingredients due to potential safety concerns raised by FDA. While this action helped to clarify FDA’s position, these peptides have never been legal for use in compounded drugs. These peptides do not meet any of the three criteria for compounding.

Despite the ongoing illegality, compounding pharmacies continue to receive prescriptions and/or inquiries from prescribers about compounded drugs containing Category 2 peptide drugs including ipamorelin, BPC-157, CJC-1295, Kisspeptin-10, or AOD9604.

While these drugs were only recently formally added to Category 2 by FDA, APC consistently maintained its position that these drugs are not lawful for use in compounded drugs. In its statement, the APC noted that prior to placement in Category 2, the peptides failed to meet the legal standard to be compounded by 503A pharmacies. Since first addressing the topic in 2020, APC has maintained a clear position regarding their illegality. A 2020 online article published by APC titled "Tempted by Peptides? Don't do it." warned compounding pharmacies of the legal risks involved in peptide compounding. This was followed by a 2021 piece titled, “Reminder: You probably can't compound that peptide." In 2022, the APC published "Compounding Peptides: It's Complicated," which reinforced the prior years' position that peptide drugs failing to meet the appropriate criteria may not be compounded. After FDA placed various peptide drugs in Category 2, APC responded through publishing an article titled "FDA puts some peptides off-limits," restating the criteria under which drugs may be compounded and stressing that the listed peptides do not meet the criteria for legal compounding.

This most recent position statement by APC reaffirms their longstanding position that the peptide drugs listed in Category 2 are not now, nor have ever been, legal to compound. The Coalition for Responsible Compounding urges pharmacies to be guided by the APC's advice and avoid the potential legal ramifications of compounding peptides.

Read the full APC statement on Category 2 peptide drugs

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