“Compounded or unapproved peptide injections pose greater safety risks than approved prescription peptide medications.”

Such compounding would unnecessarily expose patients to the risks associated with drug products that do not meet the standards applicable to FDA-approved drug products for safety, effectiveness, quality, and labeling and would undermine the drug approval process.

The tested peptide impurities pose increased immunogenicity potential. Follow-on or compounded products also had different impurity profiles, which could be affected by the sourcing of the active pharmaceutical ingredient, manufacturing process, and degradation during storage. The distinct impurity profiles of follow-on and compounded products could lead to an undesirable immune response in patients.

The FDA does not approve compounded drugs (e.g., compounded peptides), and without their review, the FDA cannot assure that compounded drugs have the same safety, efficacy, and purity of FDA-approved peptides that have gone through clinical trial testing.

However, compounded drugs pose a higher risk to patients than FDA-approved drugs because compounded drugs do not undergo FDA premarket review for safety, effectiveness, or quality.

However, compounded drugs pose a higher risk to patients than FDA-approved drugs because compounded drugs do not undergo FDA premarket review for safety, effectiveness, or quality.

Safety concerns with the use of compounded agents have been described due to less rigorous regulatory oversight as compared with manufactured medications.

However, the regulatory oversight of pharmacy compounding is significantly less rigorous than that required for Food and Drug Administration (FDA)-approved drugs; as such, compounded drugs may pose additional risks to patients. … In contrast, compounded drugs are exempt from GMPs, and testing to assess product quality is inconsistent. Unlike FDAapproved drugs, pharmacy-compounded products are not clinically evaluated for safety or efficacy. … Compounded sterile preparations pose the additional risk of microbial contamination to patients.

FDA-approved peptide drugs such as insulin and oxytocin have been available for decades. … The manufacturing process can also introduce impurities — like bacteria or heavy metals — into peptide drugs. They also are sensitive to environmental conditions and can change chemical composition if stored at the wrong temperatures or shaken too vigorously, increasing the risk of an immune response or decreasing their effectiveness. And when a substance is injected, as opposed to taken orally, it bypasses most of the body’s natural defenses.

Although the Food and Drug Administration has approved many peptide-based medications to treat serious diseases such as diabetes and cancer, peptide therapies used for anti-aging and regenerative health are largely unregulated. … The FDA allows compounding pharmacies to dispense some peptides, but has listed 19 of some of the most popular peptides as posing “significant safety risks.” … As a result, many unsafe peptides are sold on a booming gray market, including directly to consumers by entities in the U.S. and abroad that are skirting FDA rules.

Many peptides can be purchased online, in a space known as the "gray market," which practitioners have called risky because of the potential for contamination or impurities. … "At this point, we all need to be wary about putting an injection in your body without actually knowing the product," said Pessah-Pollack. "I mean, they could have arsenic in it, they could have lead. So we all need to pause. We all need to speak to our doctors." … FDA regulators said at the time that the substances "present significant safety risks" because of the lack of testing.

Peptides are the building blocks of more complex proteins, triggering hormones inside the body needed for growth, metabolism and healing. Drug companies have brought several to market as medications, including mainstay treatments for diabetes and weight loss. … In a scientific review posted ahead of the meeting, FDA scientists reiterated their longstanding concerns. Again and again, regulators said they could find little data on safety or effectiveness and raised concerns about risks of contamination, allergic reactions and quality control.

But an assortment of unapproved peptides — ranging from injectables, creams, capsules, and nasal sprays — are trending in an unregulated marketplace after the Biden administration in 2023 prohibited them from being manufactured, finding safety risks and lack of human studies to support their use. … “Those drugs have gotten to market the old-fashioned way — they established sufficient safety and efficacy,” said Peter Lurie, a former associate commissioner at the FDA, now the president of the Center for Science in the Public Interest.

However, Category 1 status would not constitute FDA approval for these peptides, meaning no validated indications, standardized dosing, or established safety and efficacy data. … These products have no quality controls, no sterility guarantees, and no pharmacovigilance oversight. The outlet adds that independent lab testing of these gray-market products has found bacterial contamination severe enough to trigger septic reactions; additionally, there is heavy metal and solvent residue from the manufacturing process and doses in some products that fall well below what was listed on the label.

Peptides prescribed by a healthcare provider and mixed by a compounding pharmacy are likely the safest bet, though that’s still no guarantee.

Because they are not regulated by the U.S. Food and Drug Administration or any other health authority, they aren’t made to the standards of pharmaceuticals. They could have bacterial, fungal, chemical or heavy metal contamination; their purity could be lower than indicated; and the dose promised may not be what you receive. … In addition to the potential harm from these products’ possible impurities, people who purchase peptides from this online gray market are likely to make lots of mistakes when injecting them, my colleagues and I found in a new study published in the journal Public Health Reports.

FDA approval for peptides, such as insulin and GLP‑1s, ensures oversight of how these medications are manufactured and distributed. But newer peptides that are not FDA‑approved carry additional risks related to possible contamination, safety, sourcing and dosing, according to Dr. Tam, particularly in the grey market where products are manufactured without FDA oversight.

A panel of federal health advisers on Thursday narrowly recommended easing access to several peptides popular with wellness influencers and celebrities, despite warnings from government scientists that the chemicals haven’t been shown to be safe or effective.

Consumers can already encounter products marketed through websites and other channels as “research use only” substances, where the identity, potency, purity, sterility, sourcing and storage of the products may be difficult to determine. … The compounding industry has an opportunity to argue that appropriately licensed pharmacies operating under established quality standards, prescription requirements and regulatory oversight may provide a more controlled environment than the gray market that has developed around peptides.

Compounded medications made without the guidance of standards may be sub-potent, super potent or contaminated, exposing patients to significant risk of adverse events or even death.

Personnel who compound allergen extracts as CSPs must be aware of greater potential risk of microbial and foreign material contamination when allergen extracts as CSPs are compounded in compliance with the foregoing criteria instead of the more rigorous standards in this chapter for CSP Microbial Contamination Risk Levels.

Patient safety advocates criticize the decision, noting these unapproved compounds, like BPC-157, lack robust human clinical trials and pose risks, including potential cancer links.

Peptides Labeled for Research Only Are Not Approved Medicines and People Are Injecting Them Anyway … The distinction matters because the label is frequently read backward. It does not mean the product has been tested and cleared for laboratory work. It means the seller is not claiming it is fit for people, which removes the manufacturing, testing, and labeling obligations that apply to medicines. … No federal body verifies purity, potency, or sterility of a research-labeled peptide before it reaches a buyer. Vendors face no mandatory third-party testing requirement.

Sterility failures are not abstract. They can result in contamination, infection, and serious patient harm.

Peptides have become one of the hottest trends in wellness, with promises like faster muscle recovery and healthier aging. And six of these compounds cleared a major hurdle last week, when an advisory panel to the US Food and Drug Administration voted in favor of making them available through compounding pharmacies.

Most recently, in September 2023, FDA added several peptides to Category 2 of its 503A Interim Bulks Guidance. Substances listed in Category 2 are not to be used as active pharmaceutical ingredients due to potential safety concerns raised by FDA in their review of the nominations that were submitted for those items. … FDA’s action to include a substance in Category 2 does not necessarily mean the agency has identified specific safety risks associated with that substance. It may mean that the documentation submitted with the nomination of that substance did not demonstrate safety to the agency’s satisfaction.

The intent of the chapter is to establish minimum standards for practitioners when compounding sterile products in order to minimize harm, including death, to human and animal patients.

Wellness Peptides Lack Reliable Safety Information, Watchdog Warns … Gray Market Peptides: So Much Hype, So Little Data

Unlike FDA approved pharmaceuticals, which undergo rigorous manufacturing, stability testing, and batch by batch quality assurance, compounded peptides exist on a quality spectrum that ranges from pharmaceutical grade products produced under cGMP conditions to unverified powders from overseas laboratories with no quality documentation.