Robert F. Kennedy Jr., the US health secretary, has called himself a 'big fan' of peptides and has described using BPC-157 for a muscle injury. On Wednesday, his Department of Health and Human Services posted a policy opening a temporary route for providers to compound six such products.
The policy says HHS will use enforcement discretion, declining to take action against state-licensed pharmacies, federal facilities and licensed physicians that compound BPC-157, TB-500, Epitalon, KPV, MOTS-c and Semax. None has FDA approval for use as a medicine.
The injectable products are promoted in the wellness industry for muscle building, injury healing and increased energy. Patients will need a valid prescription to receive them.
Kennedy has said compounding pharmacies in the US should be permitted to sell peptides because Americans are buying 'gray market' products imported from China and other countries. HHS said the expansion may help discourage growing gray and black markets for peptides.
The decision reverses the position the FDA took in 2023, when it put more than a dozen peptides, including BPC-157 and TB-500, on a list of substances that should not be compounded. The agency cited risks of allergic reactions, kidney damage and tumour growth.
An FDA advisory panel voted in July to recommend that compounding pharmacies be cleared to manufacture six of the substances. At a meeting that month, FDA staff said more than half a dozen peptides under reconsideration remained unproven for safety and effectiveness.
HHS officials initially sought an FDA regulation that would have placed BPC-157 and other peptides on a list of drug substances considered safe for compounding pharmacies. FDA officials said the agency's scientific staff had major safety concerns and would not support a regulation declaring them safe.
Those staff members later provided technical help with the HHS plan. The safeguards include requiring pharmacies to obtain peptide ingredients from FDA-registered factories.
Most FDA scientific staff opposed the policy and had limited input into drafting it. Compounding decisions have long rested with the FDA, while the agency continues to weigh whether pharmacies should be allowed to manufacture peptides.
Under the policy, compounders will be directed to gather information on side effects for safety analysis and to verify the chemical identity of peptides. HHS said it may revisit the policy if safety or product-quality problems emerge as the products become more available.
Comments (0)