Lately, there has been an uptick in patients requesting peptides for performance enhancements and anti-aging therapies. As a pharmacy, we hear from patients regularly that they want injectable peptide therapies, despite having limited knowledge about peptides. Prescribers for these therapies are unknowingly (and knowingly) sourcing compounded peptides, even though there are potential risks associated with providing patients with compounded peptides. Due to the complexity of FDA regulations and changes in recent years that reclassified many peptides as biologics, many clinicians may not even know that most injectable peptides are prohibited from compounding. Of those peptides that are eligible for compounding, there have been instances where unapproved salts have been used instead of the FDA-approved compound. Prescribers and compounding pharmacies ultimately have a responsibility to their patients to ensure that any therapeutic they provide is safe and effective and should think twice about providing compounded peptides.
How does the FDA regulate compounded injectable peptides?
Although they are similar classes of compounds composed of amino acids, the FDA distinguishes peptides as different from proteins (i.e., biologics). Per the FDA’s definition, peptides are smaller compounds with ≤ 40 amino acids, whereas proteins/biologics have > 40 amino acids. Due to this delineation, peptides are regulated as drugs, while biologics are regulated differently and are ineligible for exemptions for compounding. This regulation began in 2020, which forced many peptides to be reclassified as biologics. As biologics cannot be compounded, this action removed many peptides from compounding eligibility.
Why shouldn’t most injectable peptides be compounded?
Although the FDA does not explicitly prohibit the compounding of peptides, they typically do not meet compounding criteria under the FD&C Act. In warning letters issued to multiple compounding pharmacies, the FDA noted that some peptides are not eligible for compounding because they are “not the subject of an applicable USP or NF monograph, are not components of an FDA-approved human drug, and do not appear on the 503A bulks list.” Very few peptides meet any of these criteria, especially the FDA approval criterion, which is unlikely to change anytime soon. In fact, only 4 of the 37 approved new drugs in 2022 were peptides:
- Gadopiclenol (EluciremTM)
- Tirzepatide (MounjaroTM)
- Lutetium 177Lu Vipivotide Tetraxetan (PluvictoTM)
- Terlipressin (TerlivazTM)
Although these peptides are part of FDA-approved products (similar to semaglutide), they are the exception rather than the rule. So why are ineligible peptides still being compounded? Compounding pharmacies are likely receiving requests from prescribers and may fill such prescriptions unaware of the above restrictions–or in some cases, completely aware of the violations they are engaging in. According to Gopesh Patel, Rph and Pharmacist in Charge at VLS Pharmacy in Brooklyn, New York, “Although patients may pressure their prescribers for compounded peptide injections, reputable prescribers would be wise to refuse such requests.”
To bypass the need for a prescription, customers have gone as far as buying research-grade chemicals and administering peptide injections themselves. Many peptides are offered as research-grade products that are ineligible for compounding because they are not subject to the same strict manufacturing regulations as pharmaceutical-grade active pharmaceutical ingredients. One example of this is semaglutide, whose sodium salt, a research-grade compound, has been used in compounded formulations. The Alliance for Pharmacy Compounding (APC) has even issued warnings to its members that semaglutide sodium “should not be used in human drug compounding.”* Other times, compounded products are labeled as generics which are completely different types of compound in the eyes of the FDA.
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Responsible compounders know to source pharmaceutical-grade APIs from reputable manufacturers operating within FDA criteria, as anything less may place patients at risk. Some pharmacies have received warning letters for compounding peptides such as sermorelin acetate using non-pharmaceutical-grade components. There has also been concern surrounding the compounding of research-grade semaglutide sodium because, again, NovoNordisk does not provide semaglutide for compounding.
Risks of compounding peptides
Regulations aside, the compounding of peptides (or any other drug product, for that matter) that has not received FDA approval may put patients at risk. The FDA’s robust clinical trial process is meant to safeguard patients so that medication may be administered without unreasonable fear of major adverse events.
Without FDA approval, there’s really no sound guarantee that a product is effective or safe, and patients may simply be experiencing the placebo effect. If a patient experiences a severe adverse event from an unapproved drug such as a peptide injection, prescribers may open themselves up to potential litigation. Even in the absence of adverse events, distributing unapproved peptides can be a costly mistake. In 2020, one pharmacy was ordered to pay a fine of more than $1.7 million, and the owner himself was subject to a hefty fine and three years of probation.
Although it may feel like the compounder is letting their customers down by refusing to compound ineligible peptides, it’s in everyone’s best interest, especially patients, if they refuse such requests. Compounding peptides is simply not worth the risk.
Because it is unclear what these compounded peptides actually contain, clinicians who choose to prescribe them anyway should request a certificate of analysis for peptides such as the semaglutide sodium salt (or other peptides) and third-party stability and endotoxin testing to ensure patient safety.
Without such testing, patients may be injecting unstudied and unapproved FDA products into their bodies. Should major adverse events occur, the liability falls upon the compounding pharmacist and the prescriber.
Why Choose VLS Pharmacy and New Drug Loft?
As a 503A pharmacy specializing in sterile and non-sterile compounding, we will support you and your patients by creating safe, individualized, and effective pharmaceutical therapies. All formulations are compounded with high-quality pharmaceutical-grade APIs sourced directly from PCCA, the leader in superior-quality APIs.
For men and women at any age, feeling healthy, confident, and comfortable is of the utmost importance. Your patients’ needs will change with each life stage. As such, they require an adaptive and personalized treatment plan. By working with a trusted compounding pharmacy like VLS Pharmacy and New Drug Loft, you are expanding the possibilities for successful and sustainable care.
Reach out to our team to learn about best practices and to partner with our experts on custom compounded medications for your patients. All medications from VLS Pharmacy and New Drug Loft are prepared in a lab that follows safety and quality standards per our status as a 503A pharmacy.
*Alliance for Pharmacy Compounding. (n.d.). Tempted to compound semaglutide sodium? Don’t. APC Website. Retrieved February 22, 2023, from https://web.archive.org/web/20221105070430/https://a4pc.org/2022-11/tempted-to-compound semaglutide-sodium-dont/
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