On Tuesday, October 27, 1970, President Richard Nixon signed the Comprehensive Drug Abuse Prevention and Control Act of 1970 (Public Law 91-513, 84 Stat. 1236). His signing remarks, dated "October 27, 1970," record the event at 10:10 a.m. in the offices of the Bureau of Narcotics and Dangerous Drugs.
Title II of that 1970 statute is the Controlled Substances Act. This Controlled Substances Act 1970 framework created the five federal drug schedules, Schedules I through V, for pain medications, stimulants, and anabolic steroids.
For telehealth patients today, the practical answer is straightforward. Semaglutide, tirzepatide, and sermorelin do not appear in any of the five federal schedules. They remain prescription-only medicines, and sitting outside the DEA schedules never means a drug is unregulated.
What drug law looked like before October 27, 1970
Before October 1970, federal drug oversight was a patchwork rather than one law. According to the DEA's institutional history of 1970 to 1975, the 1970 act replaced more than 50 pieces of federal drug legislation. Earlier narcotics and dangerous-drug offices had merged into the Bureau of Narcotics and Dangerous Drugs (BNDD) in 1968.
Passing a unified replacement required compromise. In a 2004 Drug and Alcohol Dependence paper, historian Joseph F. Spillane traced debates over scheduling authority, research effects, and defining abuse. Broad language created a "big tent" for diverse views while expanding federal administrative authority.
Signing and implementation happened on separate dates. Nixon signed the act on October 27, 1970, and it took effect on May 1, 1971 under the BNDD. The Drug Enforcement Administration (DEA) itself was created on July 1, 1973.
Controlled Substances Act 1970: drug schedules explained
The compiled text of Titles II and III requires federal registration to manufacture, distribute, or dispense a controlled substance, with statutory exemptions. Dispensing includes prescribing and administering a controlled drug. Doctors and pharmacies are covered practitioners, while patients do not need DEA registration merely to receive and possess a lawfully prescribed controlled medication.
Alongside registration, 21 U.S.C. 812 established Schedules I, II, III, IV, and V based on abuse potential, accepted medical use, and dependence risk. Schedule V is still controlled, and an unscheduled prescription drug is not a sixth schedule.
| Schedule | Abuse potential | Accepted medical use | Dependence risk if abused |
|---|---|---|---|
| I | High | No currently accepted medical use; lack of accepted safety under medical supervision | Not specified in the statutory Schedule I criteria |
| II | High | Accepted medical use, or accepted use with severe restrictions | May lead to severe psychological or physical dependence |
| III | Less than I and II | Accepted medical use | May lead to moderate or low physical dependence or high psychological dependence |
| IV | Low relative to III | Accepted medical use | Limited physical or psychological dependence relative to III |
| V | Low relative to IV | Accepted medical use | Limited physical or psychological dependence relative to IV |
Phentermine, an older weight-management drug, received initial U.S. product authorization in 1959. Per the DEA's alphabetical scheduling registry, it entered Schedule IV on July 6, 1973 (38 FR 18013) after a May 9, 1973 proposal. Tirzepatide has no named entry in the federal controlled-substance schedules.
Is HGH a controlled substance, or does another rule apply?
On November 29, 1990, Congress enacted Public Law 101-647 (104 Stat. 4851), adding anabolic steroids to Schedule III effective 90 days later. Human growth hormone (hGH) did not enter Schedule III. As the DEA's July 2026 human growth hormone fact sheet states, human growth hormone is not controlled under the Controlled Substances Act.
Instead, the 1990 law revised 21 U.S.C. 333(e), which defines hGH as somatrem, somatropin, or an analogue of either. Under section 333(e), knowing distribution—or possession with intent to distribute—of hGH for human use requires a physician's order for an authorized condition. Our guide on whether peptides are legal explains that rule in detail.
Sermorelin is a separate peptide that signals the pituitary gland to release growth hormone rather than supplying hGH directly. Compounded sermorelin is different from an FDA-approved sermorelin product that was once marketed and has since been discontinued: the formulation offered here is not FDA-approved.
Geref was authorized for diagnostic testing in December 1990 and pediatric treatment in September 1997 before its June 2009 withdrawal. In a March 4, 2013 Federal Register notice, the agency found Geref was not withdrawn from sale for reasons of safety or effectiveness.
Ryan Haight Act telehealth rules and the 2026 extension
On October 15, 2008, Congress enacted the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Public Law 110-425, 122 Stat. 4820). The law applies only to prescription drugs that are controlled substances. Its baseline rule requires at least one prior in-person medical evaluation, with exceptions for covering clinicians and defined telemedicine settings.
Starting in March 2020, COVID-19 flexibilities let DEA-registered clinicians prescribe Schedule II through V medications by telemedicine without a prior in-person exam. The DEA and HHS issued a fourth temporary extension on December 31, 2025 (90 FR 61301), effective January 1, 2026 through December 31, 2026. Every prescription must still serve a legitimate medical purpose in the usual course of professional practice.
On January 17, 2025, the DEA published a notice of proposed rulemaking on telemedicine special registrations (90 FR 6541) proposing three registration tiers. In a 2025 JAMA Health Forum Viewpoint, Jacob T. Kannarkat and colleagues discussed balancing patient access, diversion safeguards, and administrative burden.
Is semaglutide a controlled substance, and are peptides controlled substances?
As of October 17, 2026, the day this article was written, neither semaglutide, tirzepatide, nor sermorelin has a named entry in 21 CFR Part 1308. In the federal records checked on that date, the fourth temporary extension remained the active telemedicine rule for scheduled drugs through December 31, 2026. No general final special-registration rule replacing the January 2025 proposal was found in the federal records checked for this article.
Current brand drug labels match that lookup. Both the Zepbound prescribing information on DailyMed (revised August 2026) and the Wegovy prescribing information on DailyMed (revised June 2026) state "DEA Schedule: None."
Even so, the DEA's Controlled Substance Schedules guidance notes that published lists are not comprehensive. Salts, isomers, derivatives, and controlled substance analogues can still be treated as scheduled. A negative lookup for specific medicines is not a blanket exemption for every peptide.
Athletic testing is a separate system from DEA scheduling. As of October 17, 2026, the day this article was written, WADA had published its September 21, 2026 announcement of the 2027 list.
The 2027 list takes effect January 1, 2027 and keeps semaglutide and tirzepatide in WADA's Monitoring Program outside the Prohibited List. Our guide to the WADA 2027 Prohibited List covers specific peptide categories.
What unscheduled status means for a prescription today
Because semaglutide, tirzepatide, and sermorelin are not scheduled, the Ryan Haight Act's federal in-person exam rule for controlled substances does not apply to them. State telehealth and pharmacy laws still govern every prescription.
As HHS guidance on licensing across state lines explains, providers must verify patient location and hold valid state authority. That authority can be a full license, compact privilege, reciprocity, temporary practice law, or state telehealth registration. Our guide to telehealth doctor state licensure covers how that check works.
Unscheduled status is also separate from product approval. Compounded semaglutide and tirzepatide are different from FDA-approved products such as Wegovy and Zepbound: the compounded formulations offered here are not FDA-approved.
Per FDA guidance on compounded drug risks, compounded drugs are not FDA-approved and do not undergo premarket review for safety, effectiveness, or quality. If a compounded drug fails quality standards—through contamination or excess active ingredient—it could cause serious injury or death. Even so, a licensed provider may still prescribe — that decision is between you and your doctor.
Clinical screening remains strict for these medications. Wegovy and Zepbound are contraindicated with a personal or family history of medullary thyroid carcinoma (MTC), a rare thyroid cancer. Both labels also contraindicate use in Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), an inherited endocrine condition.
At Promise, a licensed provider reviews every request and not everyone qualifies. Tirzepatide, semaglutide, or sermorelin prescribed through Promise is dispensed by a licensed U.S. compounding pharmacy.
