How peptides are prescribed in the US

In the US, a peptide drug reaches a patient in one of two main ways. A licensed provider can prescribe an FDA-approved peptide drug, or, in some cases, a pharmacy can compound a peptide drug for a patient based on a valid prescription ^{[1, 3]}. Compounded drugs are not FDA-approved ^[2].

Path 1: FDA-approved peptide drugs

An FDA-approved drug has gone through FDA review and has an official label. The label lists approved uses, doses, warnings and side effects. For example, the Ozempic label covers semaglutide ^[10]. You can see which peptides have approval on the FDA Peptide Status Tracker ^[10].

Providers may also prescribe an approved drug for a use that is not on the label. FDA calls this "off-label" use. FDA says providers generally may prescribe a drug for an unapproved use when they judge it is medically appropriate ^[1].

Path 2: Compounded peptide drugs

Compounding is done by licensed pharmacists or physicians under section 503A, or by outsourcing facilities under section 503B ^[2]. FDA says a drug may be compounded for a patient who cannot be treated with an FDA-approved medicine. Examples include a patient with an allergy to a dye, or a child who cannot swallow a tablet ^[2].

Compounded drugs are not FDA-approved. FDA does not verify their safety, effectiveness or quality before they are marketed ^[2]. FDA also says compounded drugs should only be used when a patient's needs cannot be met by an FDA-approved drug ^[2].

Federal law has two compounding tracks. Both come from the Drug Quality and Security Act, enacted on November 27, 2013 ^[3].

Section 503A: drugs must be compounded based on valid patient-specific prescriptions ^[3].
Section 503B: outsourcing facilities register with FDA, are primarily overseen by FDA, and may make drugs that are not for an identified individual patient ^{[2, 3]}.

Which peptides a 503A pharmacy may use

A 503A pharmacy cannot use just any raw ingredient. FDA says a bulk drug substance must meet one of three conditions ^[4]:

It complies with a USP or NF monograph, if one exists ^[4].
It is a component of an FDA-approved drug, if no monograph exists ^[4].
It appears on FDA's 503A bulks list ^[4].

While FDA reviews nominated substances, it sorts them into categories. FDA does not intend to act against compounders using Category 1 substances if its conditions are met. Category 2 substances raise significant safety risks. Category 3 substances lacked enough support. FDA could take action against compounders using Category 2 or 3 substances ^[4]. FDA's safety page lists kisspeptin-10 and ibutamoren (MK-677) in Category 2, and lists BPC-157 among substances whose nominations were withdrawn ^[5].

Compounded copies of approved peptide drugs

Compounded versions of approved peptides, such as semaglutide and tirzepatide, have drawn FDA attention. On February 6, 2026, FDA said companies cannot claim that non-FDA-approved compounded products are generic versions of approved drugs ^[8]. On March 3, 2026, FDA announced 30 warning letters to telehealth companies over false or misleading claims about compounded GLP-1 products ^[7].

The letters named claims implying sameness with FDA-approved products. They also named ads that obscured where the drug came from, by branding it with the telehealth firm's name ^[7]. FDA says the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed ^[9].

Telehealth prescribing rules

Many people now see providers by video. The best-known federal telehealth prescribing rule covers controlled substances ^[6].

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 generally requires at least one in-person medical evaluation before a practitioner prescribes a controlled substance online ^[6]. During COVID-19, DEA and HHS allowed exceptions. A fourth temporary extension lets DEA-registered practitioners prescribe schedule II to V controlled substances by telemedicine without a prior in-person visit. It is effective January 1, 2026 through December 31, 2026 ^[6].

These DEA rules apply only to controlled substances ^[6]. Whether a given peptide is a controlled substance is a separate question. Check the FDA and DEA status of each drug, and see our pages on semaglutide and tirzepatide for approved peptide examples ^{[6, 10]}.

What this means for readers

An FDA-approved peptide drug and a compounded peptide drug follow different rules. Only the approved drug has been reviewed by FDA for safety, effectiveness and quality before marketing ^{[2, 4]}. For the risks, read peptide safety basics. For the basics, read what is a peptide ^[5].

Frequently asked questions

Do you need a prescription for compounded peptides?

Under section 503A, drugs must be compounded based on valid patient-specific prescriptions ^[3].

Can a doctor prescribe a peptide off-label?

For FDA-approved drugs, FDA says providers generally may prescribe for an unapproved use when they judge it medically appropriate ^[1].

Are compounded peptides FDA-approved?

No. FDA says compounded drugs are not FDA-approved and it does not verify their safety, effectiveness or quality before marketing ^[2].

What is the difference between a 503A pharmacy and a 503B outsourcing facility?

503A compounding is based on patient-specific prescriptions. 503B outsourcing facilities register with FDA and may make drugs not for an identified individual patient ^[3].

Can a compounded drug be called a generic?

FDA said on February 6, 2026 that companies cannot claim non-FDA-approved compounded products are generic versions ^[8].

Can telehealth providers prescribe controlled substances without an in-person visit?

Under a temporary DEA and HHS rule, yes, for schedule II to V drugs, from January 1, 2026 through December 31, 2026, if the rule's conditions are met ^[6].