Is progesterone legal in the US? A guide to FDA-approved, compounded, and OTC options

October 7, 2025 •

4 min read

According to the FDA, several mass-produced versions of progesterone, such as Prometrium and Endometrin, have been tested and approved for use in the United States. However, when considering the question, 'is progesterone legal in the US?', the answer depends heavily on the specific product, its manufacturing, and its intended use. The legal landscape varies significantly between FDA-regulated prescriptions, custom-made compounded treatments, and over-the-counter creams.

Quick Summary

Progesterone's legality in the United States hinges on its formulation. Legal access includes FDA-approved, mass-produced prescription drugs, as well as custom-compounded medications regulated by state pharmacy boards. Over-the-counter progesterone creams, however, are unregulated by the FDA for therapeutic claims.

Key Points

Prescription Legality: FDA-approved progesterone, like Prometrium, is legal and requires a doctor's prescription for specific therapeutic uses.
Compounded Legality: Custom-made progesterone (BHRT) is legal via prescription from a compounding pharmacy, which is regulated by state boards, but the individual final product is not FDA-approved.
OTC Unregulated Status: Over-the-counter progesterone creams are legal but are not regulated by the FDA for safety or efficacy, and are often sold as cosmetics.
Reliable Dosing: Only prescription-grade progesterone (FDA-approved or compounded under strict controls) offers reliable and consistent dosing, unlike inconsistent OTC creams.
Professional Guidance is Key: Due to significant differences in product quality and regulation, medical supervision is crucial for anyone considering progesterone therapy.

Navigating the legality of progesterone in the United States can be complex due to the varying forms and manufacturing processes available. While the core hormone is widely used and accepted, its regulation differs dramatically based on whether it is a mass-produced prescription, a custom-compounded formula, or an over-the-counter (OTC) cosmetic cream.

Prescription Progesterone: FDA-Approved and Regulated

The most straightforward legal route for obtaining progesterone is through a doctor's prescription. The Food and Drug Administration (FDA) has approved several progesterone products that are manufactured by large pharmaceutical companies under strict regulations for safety, purity, and efficacy.

These FDA-approved products include:

Oral Capsules: Micronized progesterone in oral capsules, such as Prometrium, is commonly prescribed to protect the uterus in postmenopausal women receiving estrogen therapy and to help regulate menstrual cycles.
Vaginal Inserts and Gels: Products like Endometrin and Crinone are FDA-approved to support embryo implantation and early pregnancy as part of Assisted Reproductive Technology (ART) treatments.
Injections: Certain progesterone injections are also approved for specific therapeutic uses.

To access these medications, a patient must receive a formal diagnosis and prescription from a licensed healthcare provider. This process ensures the patient is using a regulated, standardized product under medical supervision.

Compounded Progesterone: Custom Prescriptions with Oversight

Compounded bioidentical hormone therapy (BHRT) is a legal and popular option for many patients seeking customized treatment plans. Compounded hormones are prepared by a licensed compounding pharmacist in response to a doctor's prescription.

Key aspects of compounded progesterone include:

Customization: The dosage and delivery method (e.g., creams, troches, suppositories) can be tailored to a patient's specific needs.
Regulatory Oversight: While the final compounded product is not FDA-approved, the bulk ingredients used by compounding pharmacies are sourced from FDA-inspected facilities and are regulated by the U.S. Pharmacopoeia. Additionally, state boards of pharmacy regulate all pharmacies that compound medications.
Risk Factors: The primary concern with compounded BHRT is the lack of standardized testing for the finished product. This can lead to variations in strength, absorption, and potential side effects that are not as well-documented as with FDA-approved products. Many medical associations advise caution due to the limited research on compounded hormones compared to their mass-produced counterparts.

Over-the-Counter (OTC) Progesterone Creams: Unregulated and Inconsistent

Over-the-counter (OTC) progesterone creams are widely available at drugstores and online, but their legal status and regulation are vastly different from prescription versions. The FDA does not regulate these products for therapeutic use. Instead, they are often classified as cosmetics, meaning their manufacturers are not required to prove their products' safety or effectiveness for medical purposes.

Concerns associated with OTC creams include:

Inconsistent Dosing: The amount of progesterone in OTC creams can vary greatly between brands and even within the same product, making consistent dosing impossible.
Variable Absorption: Transdermal absorption of hormones is notoriously inconsistent and can be affected by skin type, hydration, and application site, leading to unpredictable hormone levels in the body.
Ineffective for Endometrial Protection: When a woman with a uterus is also using estrogen, adequate progesterone is essential to protect the uterine lining. Most OTC creams do not deliver a high enough or reliable enough dose for this purpose, putting users at risk.
Lack of Medical Supervision: Using OTC creams bypasses a licensed healthcare provider, leading to unsupervised use without proper counseling, screening, or monitoring.

The Legal Landscape: A Comparison of Progesterone Product Types


Feature	Prescription (FDA-Approved)	Compounded (BHRT)	Over-the-Counter (OTC)
Regulation	FDA-approved and strictly regulated for safety and efficacy.	Bulk ingredients are FDA-regulated; compounding pharmacies are regulated by state boards.	Unregulated for therapeutic claims; often classified as cosmetics.
Dosing	Standardized, verified, and consistent doses per application.	Customized dosage per patient, but batch-to-batch variation is possible.	Highly variable and potentially inconsistent.
Absorption	Reliable and predictable systemic absorption is confirmed through clinical trials.	Dependent on patient and application site; less predictable than oral forms.	Unpredictable and inconsistent absorption.
Oversight	Requires a prescription and regular medical monitoring.	Requires a doctor's prescription and pharmacy oversight.	Available without medical supervision; no professional oversight.
Purpose	Treatment of specific conditions (e.g., menopause symptoms, fertility issues).	Customized treatment for hormonal imbalances.	Non-therapeutic use, often marketed with unsubstantiated wellness claims.

Progesterone vs. Progestin: A Legal and Chemical Distinction

It's important to distinguish between bioidentical progesterone and synthetic progestins. Bioidentical progesterone is chemically identical to the hormone produced by the human body. Progestins, such as medroxyprogesterone acetate (Provera), are synthetic compounds that mimic progesterone's effects. Both are legal in the US, but are regulated differently. Some FDA-approved products contain progestins, not bioidentical progesterone, and they are used for various hormone therapies and contraception.

The Evolving Regulatory Landscape: The Case of Makena

Regulatory action can change the legality and availability of specific progesterone products. A notable recent example is the FDA's withdrawal of approval for Makena (hydroxyprogesterone caproate) in 2023, a drug previously used to prevent recurrent preterm birth. This decision was based on new data showing the drug was not effective, even though it was safe. This illustrates that legality is not permanent and is subject to ongoing review based on scientific evidence.

Conclusion: Making Informed Decisions

In summary, the question "Is progesterone legal in the US?" has a nuanced answer. Yes, various forms are legal, but their safety, consistency, and therapeutic claims are tied to their regulatory pathway. FDA-approved prescriptions offer the highest level of regulatory assurance, while compounded prescriptions provide customization under state pharmacy oversight. OTC creams, in contrast, are unregulated for therapeutic effect and lack reliable dosage and absorption. For any medical use of progesterone, consulting a qualified healthcare provider is essential to determine the most appropriate and safest option for your needs.

For more information on FDA regulations and specific drug approvals, visit the official FDA website [1.g.1].

Frequently Asked Questions

No, progesterone is not classified as a controlled substance in the United States.

You can legally purchase over-the-counter progesterone creams without a prescription. However, these products are not FDA-regulated for therapeutic claims and lack consistent dosing, making them unsuitable for medical treatment.

Yes, compounded bioidentical hormones are legal when prescribed by a doctor and prepared by a licensed compounding pharmacy. While they are not individually FDA-approved, they use FDA-regulated ingredients and are subject to state pharmacy board oversight. However, safety and efficacy data are less extensive compared to FDA-approved alternatives.

Progesterone is the bioidentical hormone, chemically identical to what the body produces. Progestins are synthetic compounds that mimic progesterone. Both are legal and used in hormone therapy, but progestins are distinct chemical entities.

OTC progesterone creams are unreliable because they are unregulated for medical purposes, leading to inconsistent dosing and variable absorption. The amount of hormone delivered is not standardized or guaranteed, making it difficult to achieve a therapeutic effect or ensure safety, particularly for endometrial protection.

Yes, FDA-approved progesterone products, such as vaginal inserts and gels like Endometrin, are indicated to support early pregnancy and embryo implantation as part of Assisted Reproductive Technology (ART) treatment programs.

Yes, Prometrium (micronized progesterone oral capsules) is an FDA-approved prescription medication and cannot be obtained legally without a prescription from a healthcare provider.