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Adding 503A Compounded Hormones

Revisado por el equipo editorial de ExaVeyra Sciences · Actualizado el 16 de agosto de 2026

Compounding exists so that a prescriber can specify a strength and a dosage form the manufactured range does not cover. That is a genuine and long-standing clinical need, and hormone formulations are where practices use it most, because the commercially manufactured products come in a small set of fixed strengths while prescriber protocols often call for a finer ladder or a different vehicle. A practice adding this line is buying flexibility that the approved range does not offer.

What follows is the procurement and compliance picture: how compounded preparations sit alongside approved products, what the current rulemaking actually says, how dating and documentation work, and where testosterone is a different case from the rest. This page makes no claim about what hormone therapy achieves. That is a prescriber judgment and a patient conversation.

Where compounded sits next to approved

FDA-approved menopausal hormone therapy products exist in several forms and are the reference point. A compounded preparation is not an FDA-approved finished drug product, and it is prepared under section 503A against a prescription for an identified individual patient. Neither of those facts makes it a lesser option. They describe a different regulatory route with different appropriate uses.

The National Academies of Sciences, Engineering, and Medicine reviewed compounded bioidentical hormone therapy at FDA’s request and published its consensus report in July 2020. The committee recommended that use be restricted to patients who cannot use an FDA-approved product, specifically those with an allergy or sensitivity to an ingredient in an approved product, and those who need a dosage form that is not commercially available. Stating that plainly on a supplier page is better than letting a prescriber find it elsewhere and wonder what else was left out.

The difficult-to-compound rulemaking, accurately

A widely repeated claim holds that FDA has proposed adding eleven hormone substances to the difficult-to-compound lists, which would end compounded hormone therapy. Checked against the rulemaking itself, that is not what is on the table.

FDA published its proposed rule on Demonstrable Difficulties for Compounding on 20 March 2024 at 89 FR 19776, docket FDA-2023-N-0061, with comments closing on 18 June 2024. The rule proposes criteria for the DDC Lists and identifies the first three categories to go on them: oral solid modified-release drug products that employ coated systems, liposome drug products, and drug products produced using hot melt extrusion. The published text does not name hormones, estradiol, progesterone or testosterone anywhere.

What is true is that cBHT substances were nominated to the difficult-to-compound docket some years ago and were discussed by the Pharmacy Compounding Advisory Committee. A nomination and a committee discussion are early steps. Placing a product category on a DDC list requires notice-and-comment rulemaking that names it, and no such rule has been published.

The November 2025 labeling changes

On 10 November 2025 FDA informed application holders of menopausal hormone therapy products of requested labeling changes, following an expert panel held on 17 July 2025 and a review of the literature published since the Women’s Health Initiative studies. The changes are specific, and they cut in both directions, so it is worth setting out what moved and what stayed.

One point of care for anyone summarizing this. The endometrial cancer Boxed Warning was retained for systemic estrogen-alone products, so "FDA removed the boxed warnings from hormone therapy" is only half the sentence. These changes apply to the labeling of FDA-approved products. A compounded preparation has no FDA-approved labeling, which is one of the practical differences between the two routes.

Testosterone is a different case

Testosterone and the other anabolic steroids were placed in Schedule III of the Controlled Substances Act by the Anabolic Steroid Control Act of 1990, and they are listed at 21 CFR 1308.13. Everything that follows from Schedule III status applies, and it is a different operating burden from the rest of the hormone category.

• The prescriber needs state authority to prescribe controlled substances and a current DEA registration.
• Any practice location that stores or dispenses controlled substances has its own registration, storage, recordkeeping and inventory obligations.
• Prescription drug monitoring program reporting applies, and the requirements are set by each state rather than federally.
• State rules on refills, quantity limits and telemedicine prescribing of controlled substances vary and are frequently stricter than the federal floor.

On the clinical side, the Endocrine Society clinical practice guideline on testosterone therapy in men with hypogonadism remains the standard reference, and it is worth a prescriber reading it directly rather than in summary. It is cited in full below.

Dosage forms, dating and documentation

Compounded preparations carry a beyond-use date rather than an expiration date. USP General Chapter 795 governs nonsterile preparations, which covers capsules, creams and troches, and General Chapter 797 governs sterile preparations. Revised versions of both became official on 1 November 2023, and 797 replaced the older risk-level scheme with Category 1, 2 and 3 preparations, each with its own dating limits.

The practical consequence for a purchasing practice is that a longer beyond-use date reflects the standard the pharmacy maintains rather than a property of the hormone. Asking which chapter and which category a preparation is made under is a more useful question than asking how long it will keep.

Three records carry a hormone service line, and they should agree with each other: the prescription and the chart note explaining why an approved product was unsuitable, the pharmacy’s documentation of strength, form and beyond-use date, and whatever the practice says publicly about the service. Where the public description reaches further than the chart supports, the public description is the one to change.

A checklist before the first order

• Confirm the pharmacy is licensed in your state and, for sterile preparations, ask which USP 797 category it operates to.
• Ask for the strength ladder, dosage forms and beyond-use dating in writing, and check they match the protocol your prescribers will actually use.
• Put a one-line rationale for the compounded preparation into the chart template, so it is captured at the point of prescribing.
• Confirm whether anything you are considering is a controlled substance, and if so whether your DEA registration and state obligations are current before you order.
• Review your public-facing description of the service against what the prescriptions and protocols say.
• Watch docket FDA-2023-N-0061 for DDC rulemaking rather than relying on trade summaries.

Fuentes

1. FDA, Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding, proposed rule, 89 FR 19776 (20 March 2024) (consultado el 16 de agosto de 2026)
2. FDA, National Academies (NASEM) Study on the Clinical Utility of Treating Patients with Compounded Bioidentical Hormone Therapy (consultado el 16 de agosto de 2026)
3. FDA, Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies (10 November 2025) (consultado el 16 de agosto de 2026)
4. FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (consultado el 16 de agosto de 2026)
5. FDA, Drugs@FDA, approved drug products database (consultado el 16 de agosto de 2026)
6. 21 CFR 1308.13, Schedule III of the Controlled Substances Act (consultado el 16 de agosto de 2026)
7. DEA Diversion Control Division, Controlled Substance Schedules (consultado el 16 de agosto de 2026)
8. FDA, Information for Outsourcing Facilities (section 503B) (consultado el 16 de agosto de 2026)

Literatura científica

Cada fuente indica qué tipo de estudio fue y, cuando el estudio incluyó personas, cuántas. El diseño del estudio determina qué puede establecer un resultado, de modo que se declara en lugar de dejarlo a la inferencia. Cada línea señala además qué aporta esa fuente en esta página.

1. “The 2022 Hormone Therapy Position Statement of The North American Menopause Society” Advisory Panel The 2022 hormone therapy position statement of The North American Menopause Society. Menopause, 2022. doi:10.1097/GME.0000000000002028 PMID:35797481Clinical guidelineSource 1 supports: The reference position on menopausal hormone therapy, cited for what the approved options are before a compounded preparation is reached for.
2. Bhasin S, Brito JP, Cunningham GR, et al. Testosterone therapy in men with hypogonadism: an Endocrine Society clinical practice guideline. The Journal of Clinical Endocrinology and Metabolism, 2018. doi:10.1210/jc.2018-00229 PMID:29562364Clinical guidelineSource 2 supports: The reference guideline on testosterone therapy in men, cited so a prescriber reads the diagnostic threshold and the monitoring plan directly rather than in summary.
3. Liu Y, et al. Safety and efficacy of compounded bioidentical hormone therapy (cBHT) in perimenopausal and postmenopausal women: a systematic review and meta-analysis of randomized controlled trials. Menopause, 2022. doi:10.1097/GME.0000000000001937 PMID:35357369Meta-analysis1,808 participantsSource 3 supports: The pooled randomized evidence on compounded bioidentical hormone therapy specifically, across 29 trials. This is the direct evidence base for the subject of this page, rather than evidence about approved products.
4. National Academies of Sciences, Engineering, and Medicine The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. National Academies Press, 2020. doi:10.17226/25791Consensus statementSource 4 supports: The consensus report FDA commissioned, cited for its recommendation restricting compounded hormone therapy to patients who cannot use an approved product.