Bio-Identical Compounded Hormones and the FDA Regulations

  1. What is “compounding”? In general, compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.
  2. Is combining two or more drugs considered compounding? Yes, compounding includes the combining of two or more drugs. 
  3. Why do some patients need compounded drugs? Sometimes, the health needs of a patient cannot be met by an FDA-approved medication. For example:
     a)
    if a patient has an allergy and needs a medication to be made without a certain dye; or

b) if an elderly patient or a child can’t swallow a pill and needs a medicine in a liquid form that is not otherwise available.

 

4.     Are compounded drugs approved by the FDA?Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, or effectiveness of compounded drugs. Consumers and health professionals rely on the drug approval process to ensure that drugs are safe and effective and made in accordance with Federal quality standards. Compounded drugs also lack an FDA finding of manufacturing quality before such drugs are marketed. 

Generally, state boards of pharmacy will continue to have primary responsibility for the day-to-day oversight of state-licensed pharmacies that compound drugs in accordance with the conditions of section 503A of the FDCA, although FDA retains some authority over their operations. However, outsourcing facilities that register under section 503B are regulated by FDA and must comply with CGMP requirements and will be inspected by FDA according to a risk-based schedule. 

 

5.     What are the risks associated with compounded drugs? There can be health risks associated with compounded drugs that do not meet federal quality standards.  Compounded drugs made using poor quality practices may be sub- or super‑potent, contaminated, or otherwise adulterated. Additional health risks include the possibility that patients will use ineffective compounded drugs instead of FDA-approved drugs that have been shown to be safe and effective.  
 

6.     Who regulates and inspects facilities that compound drugs? Generally, state boards of pharmacy will continue to have primary responsibility for the day-to-day oversight of state-licensed pharmacies that compound drugs in accordance with the conditions of section 503A of the FDCA, although FDA retains some authority over their operations. For example, the adulteration or misbranding of drugs compounded under section 503A, or false or misleading statements in the labeling or advertising of such drugs, may result in violations of Federal law. Firms that register with FDA as “outsourcing facilities” under section 503B will be regulated by FDA and inspected by FDA according to a risk-based schedule.