From the Guidelines
Oxandrolone compounding is legally permissible in the United States when done by licensed pharmacies with a valid prescription for legitimate medical purposes, in accordance with FDA regulations and state pharmacy laws. The use of oxandrolone, a Schedule III controlled substance, is subject to strict regulations, including proper record-keeping and adherence to prescribing limitations by healthcare providers 1.
Key Considerations
- Oxandrolone can only be legally obtained with a valid prescription for legitimate medical purposes, such as treating weight loss in patients with HIV/AIDS, promoting weight gain after trauma or surgery, or addressing certain types of anemia.
- Licensed pharmacies can compound oxandrolone when commercially manufactured versions are unavailable or unsuitable for specific patient needs, but this must be done on a patient-by-patient basis with a valid prescription.
- Bulk compounding for office use or distribution is generally prohibited, and patients should be aware that obtaining oxandrolone without a prescription is illegal and potentially dangerous.
Regulatory Framework
The legal status of compounded oxandrolone varies internationally, so patients should consult local regulations if outside the United States. In the US, healthcare providers prescribing oxandrolone must follow DEA requirements, including proper record-keeping and adherence to prescribing limitations 1.
Medical Use
Oxandrolone has been shown to have benefits in severe burns, including reduced weight loss, increased lean body mass, improved donor-site healing, and reduced length of stay without an increase in infection, hyperglycemia, or liver dysfunction 1. However, its use should be carefully considered and monitored by a healthcare provider to ensure safe and effective treatment.
From the FDA Drug Label
DRUG ABUSE AND DEPENDENCE Oxandrolone is classified as a controlled substance under the Anabolic Steroids Control Act of 1990 and has been assigned to Schedule III (non-narcotic).
- Controlled Substance: Oxandrolone is a Schedule III controlled substance.
- Legal Implications: As a controlled substance, there are specific regulations and restrictions on its use, possession, and distribution, including compounding.
- Compounding: The FDA drug label does not provide direct information on the legalities of compounding oxandrolone, but its classification as a Schedule III controlled substance implies that compounding must comply with relevant laws and regulations 2.
From the Research
Legalities of Oxandrolone Compounding
- The legalities of oxandrolone being compounded are not directly addressed in the provided studies 3, 4, 5, 6, 7.
- However, it is mentioned that oxandrolone is US FDA-approved for certain medical conditions, such as restitution of weight loss after severe trauma, major surgery or infections, malnutrition due to alcoholic cirrhosis, and Duchenne's or Becker's muscular dystrophy 3.
- The studies focus on the efficacy and safety of oxandrolone in treating various medical conditions, including burn injuries, HIV-related muscle wasting, and neuromuscular disorders 3, 4, 5, 7.
- There is no discussion on the legal aspects of compounding oxandrolone, suggesting that the provided evidence may not be directly relevant to answering this question.
Regulatory Status of Oxandrolone
- Oxandrolone is a synthetic testosterone analog that is regulated by the US FDA 3.
- It is approved for specific medical uses, but its use for other purposes, such as athletic performance enhancement, is not approved and may be subject to legal restrictions.
- The regulatory status of oxandrolone may vary depending on the country and jurisdiction, but the provided studies do not address this topic in detail.
Compounding of Oxandrolone
- Compounding of oxandrolone may be subject to regulatory oversight, but the provided studies do not discuss this topic.
- It is possible that compounding of oxandrolone may be allowed for specific medical purposes, but this would depend on the regulatory framework in place.
- Further research would be needed to determine the legalities of oxandrolone compounding, as the provided studies do not provide sufficient information on this topic 3, 4, 5, 6, 7.