Is Testosterone a Controlled Substance? Schedule III Rules

Yes. Testosterone is a Schedule III controlled substance, entry (84) among the anabolic steroids in 21 CFR 1308.13(f) (title 21 of the Code of Federal Regulations). A Schedule III prescription cannot be filled or refilled more than six months after it was written, and cannot be refilled more than five times (21 CFR 1306.22). As of October 2026 the listing is unchanged.

Schedule III is the tier for drugs with an accepted medical use and a lower abuse potential than Schedules I and II, according to the DEA's schedules page. An anabolic steroid is any drug or hormonal substance chemically and pharmacologically related to testosterone, other than estrogens, progestins, corticosteroids and dehydroepiandrosterone (DHEA), under 21 CFR 1300.01.

Congress put anabolic steroids into Schedule III through the Anabolic Steroids Control Act of 1990, a law aimed at steroid misuse in sport. It amended the Controlled Substances Act. The schedule did not stop testosterone from being a medicine. The FDA approves testosterone products for men whose low testosterone is linked to a medical condition, and prescribers write for them under controlled-substance rules.

A Schedule III prescription ends six months after the date written or after the fifth refill, whichever comes first. That is one original fill plus five refills, six fills in all. The prescriber sets the number of refills, up to five, on the original prescription. Only a new prescription can continue treatment past either limit.

The size of each fill decides which limit you hit first. This is our own calculation from 21 CFR 1306.22, not an official figure. Assumptions: the prescription is written on January 1 of a non-leap year, so six months is 181 days. The prescriber authorizes five refills, and each fill is taken the day the previous supply ends. Real timing can be earlier or later depending on state law, pharmacy policy and your insurer.

• 28-day fills: the refill count runs out first. Supply ends on day 168, about 13 days before the six-month date (day 181).
• 30-day fills: both limits arrive almost together. Supply ends on day 180, one day before the six-month date.
• 90-day fills: the date limit binds. The third fill falls on day 180, and a fourth would land on day 270, long after the prescription expired.

Our inference: larger fills cover more days per prescription, because the date limit, not the refill count, caps them. They are only possible if the prescriber writes that quantity and your state and insurer allow it.

Run five checks, each with a clear pass or fail, about two weeks before your next fill is due. Fourteen days is our recommendation, not a legal threshold. It leaves time for a prescriber to review the request and send a new prescription.

Federal law sets only the five-refill and six-month limits. It does not set an earliest refill date. A pharmacy that refuses an early refill is applying state law, its own policy or your insurer's rules, so ask which one applies.

Yes. The federal listing covers testosterone and, by definition, its esters, ethers, isomers and salts, so cypionate and enanthate are included. The entry names the substance, not a dosage form, so a gel or cream containing testosterone does not change the listing.

The definition in 21 CFR 1300.01 reaches those variants "whenever the existence of such isomers, esters, ethers, and salts is possible." It excludes estrogens, progestins, corticosteroids and DHEA. Prednisone and hydrocortisone, for example, belong to a different drug class and are not covered. Nothing in entry (84) separates injections from topical products. For how the esters differ once you are choosing one for a formulation, see our guide to which testosterone ester fits your formulation.

Yes. New York lists testosterone in Schedule II, and California ties its schedule to the federal one. States, insurers and pharmacies can also add rules the federal text does not contain, so the federal calendar above is a starting point, not a guarantee.

• New York. New York Public Health Law §3306 lists anabolic steroids in Schedule II, subdivision (h), with testosterone as item (60). Schedule II is a stricter tier, so a New York prescription should not be assumed to follow the six-month, five-refill pattern. Ask the prescriber how yours works.
• California. AB 1778, approved August 24, 2026, ties California's classification to the federal one. If testosterone is rescheduled or exempted federally, California follows.

Not yet. As of October 2026, 21 CFR 1308.13 still lists testosterone in Schedule III. An FDA expert panel on testosterone replacement therapy met on December 10, 2025, and trade reporting says it recommended removing the Schedule III designation. That recommendation is advisory. It is not FDA or DEA action and does not change the schedule.

In June 2026 the FDA requested that manufacturers update testosterone prescribing information, including removing the limitation of use for age-related low testosterone and revising prostate-related safety information. Those are labeling changes, not scheduling changes.

Rescheduling requires a final DEA rule or an Act of Congress, and neither has happened as of October 2026. Our expectation: if DEA moves, it will publish a proposed rule in the Federal Register and take comments before any final change. Until a final rule is published, plan around the Schedule III limits.

A buyer needs to settle the exact product, the import authorization and the permitted end use before any commercial order. At Aarise Pharmaceuticals, in Haridwar, India, we supply bulk APIs and raw materials, including testosterone derivatives, to qualified business-to-business (B2B) buyers: generic drug manufacturers, contract formulators, distributors and importers. We do not sell to individual patients or consumers. For the wider supplier checks a US manufacturer should run, see our guide on how to qualify a hormone API supplier for US manufacturing.

Our quotation starts from these inputs:

• Product or CAS number. The Chemical Abstracts Service registry number identifies the exact ester.
• Quantity and destination country.
• Grade or purity and the documents you need. These can include a certificate of analysis (COA), specifications and a safety data sheet (SDS), where applicable.
• Payment terms and Incoterms. These are the international trade terms that set who handles shipping and risk.

We confirm price, minimum order quantity and lead time product by product in the quotation, and we do not publish a single price for the portfolio. We can support evaluation quantities for qualified buyers before you commit to bulk.

For a US importer, the federal import rules sit in 21 CFR Part 1312. Importers must be registered with DEA or exempt. Testosterone is a non-narcotic Schedule III substance, so it needs an import declaration, not a permit. Section 1312.18 requires DEA Form 236, filed no later than 15 calendar days before the anticipated customs release, and the filing is valid only after DEA issues a transaction identification number. A separate declaration is required for each shipment. Confirming local registration, import authorization and permitted end use is the buyer's responsibility before commercial supply. We review availability and documentation for your destination. Our recommendation is to confirm your registration status and filing timing with the DEA Diversion Control Division before you order.

To request a quotation, use the product inquiry option on our contact form, or write to sunil@aarisepharma.com or message +91 9899783330 on WhatsApp. Send the API name, CAS number, quantity and destination country.