APC Statement on Compounded HCG and Peptides
The Alliance for Pharmacy Compounding (APC) provided an explanation regarding their advocacy around compounded HCG and peptides.
APC is leading the effort to bring the importance of compounding pharmacies to the forefront of legislative discussions at state and federal levels. We’re providing this explanation to help our patients stay informed about ongoing regulatory shifts in the field of integrative health.
Fairly regularly, we get asked why HCG and peptides can’t be compounded and why APC can’t do something about it. Here’s the skinny:
HCG was swept up in legislation passed by Congress a dozen years ago (but which did not take effect until March 2020) that reclassified a number of substances as biologics, which put them outside the reach of most 503A compounders. Despite our efforts, FDA has shown no interest in exercising enforcement discretion in allowing HCG to continue to be compounded.
Over the past 24 months we’ve put out at least two calls for our members to help us collect data demonstrating patient harm — demonstrating that patients have not been able to access essential therapies — that has resulted from the reclassification, but the fact is, we’ve not received any such data. We do believe that kind of data would be useful in making a case to FDA.
“Why not just change the law?” you’re probably thinking. Easy answer: Big Pharma and its regiment of lobbyists. It’s frankly not a Capitol Hill fight we think we can win, and to have to give our limited bandwidth to such a fight will take our attention away from other important and more winnable battles.
Peptides are a bit different. Peptides are not restricted per se. The reason you generally can’t compound them (and there are exceptions, like semaglutide and sermorelin) is because they do not meet FDA’s criteria:
• They don’t have a USP or NF monograph
• They’re not part of an FDA-approved drug product
• They’re not on the Category 1 or “positive” lists
APC also provided this follow-up on the subject of peptides:
Several members wrote to us after reading our story about compounding peptides to ask, “Why are semaglutide and sermorelin exceptions to the peptide rule?”
A good question! For the answer, we reached out to APC Vice President Tenille Davis, PharmD, of Civic Center Pharmacy in Scottsdale. Here’s what she told us:
“Sermorelin and semaglutide meet the criteria for compounding because they are part of an FDA approved drug product — one of three criteria we use to determine if an API is eligible to be used in compounding.
“They are not considered biologics (which we cannot compound) because they contain fewer than 40 amino acids in their sequence. Keep in mind that we cannot compound a copy of a commercially available medication, but if a patient needed semaglutide in a nasal spray, for example, it would be legal to compound it.
“Think of them as commonly used peptides that we compound with, like oxytocin. Oxytocin is a peptide hormone but it is not a biologic.”