Oral Micronized Progesterone International Purchase Legalities: What You Need to Know

What oral micronized progesterone is in the US

Prometrium 100 mg and 200 mg capsules contain micronized progesterone for oral use. The application is NDA 019781, first approved on 1998-05-14, and the current label is Revision 02/2026 [1][3]. Generic progesterone capsules are also marketed in the US [3].

The label has only two indications: prevention of endometrial hyperplasia in postmenopausal women with a uterus who are taking conjugated estrogens tablets, and secondary amenorrhea [1]. The labeled dose is 200 mg at bedtime for 12 days of each 28-day cycle with conjugated estrogens, or 400 mg at bedtime for 10 days for secondary amenorrhea [1].

Federal import provisions and buying online

Chapter VIII of the Food, Drug, and Cosmetic Act covers imports and exports. Its listed sections include section 801 on imports and exports and section 804 on importation of prescription drugs [2]. The page is a list of section titles and does not state whether patients may import progesterone for personal use [2].

FDA's compounding page notes that buying medicine online from unregulated, unlicensed sources can expose patients to poor-quality products [4]. It also says consumers who buy compounded drugs through online pharmacies or telehealth platforms may not know which compounder made the drug, or whether that compounder is appropriately licensed and regulated [4].

Compounded progesterone sold online

Compounded drugs are not FDA-approved, and FDA does not verify their safety, effectiveness or quality before they are marketed [4]. A generic drug is a different category: it is approved under section 505(j) and must meet that section's requirements, including establishing therapeutic equivalence to the brand-name drug [4]. FDA says compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug, and that poor compounding practices can produce contamination or a product with too much or too little active ingredient [4].

Label details that matter when comparing products

The prescribing information describes Prometrium capsules, not any foreign product. Three points from that label matter for any comparison.

Peanut allergy is a contraindication, not just a caution. The capsules contain peanut oil, and the label lists hypersensitivity to the ingredients, including peanut allergy, as a contraindication [1].

The label says Prometrium may cause transient dizziness and drowsiness and should be used with caution when driving or operating machinery. It says the capsules should be taken as a single daily dose at bedtime. During initial therapy a few women have had extreme dizziness or drowsiness, blurred vision, slurred speech, difficulty walking and loss of consciousness [1][3].

Food changes absorption. Taking the 200 mg dose with food increased bioavailability compared with fasting in postmenopausal women [3]. The label also states that pharmacokinetics have not been studied in hepatic impairment, renal impairment or obesity [3].