Compounded drugs must not be essentially copies of a commercially available drug in order to qualify for exemptions from certain requirements of the federal Food, Drug, and Cosmetics Act (FDC Act) (21 U.S.C. §301 et seq.). This requirement applies both to licensed pharmacists and physicians as well as outsourcing facilities. According to the FDA’s draft guidances on the topic, this restriction is intended to ensure that sponsors continue to develop drugs that are required to go through the FDA’s approval processes (Notice, 81 FR 44879, July 11, 2016; Notice, 81 FR 44881, July 11, 2016).
Compounded drugs. Drugs are compounded for certain patients who are unable to take an approved drug product, such as those that need a lower-strength dosage, cannot swallow a pill, or are allergic to dyes. Drugs can be compounded under section 503A of the FDC Act by licensed pharmacists and physicians or under section 503B by outsourcing facilities registered with the FDA. If compounded by pharmacists and physicians under appropriate conditions, the drugs can qualify for exemption from requirements for current good manufacturing practices (CGMP), drug labeling, and approval under new drug applications (NDAs) or abbreviated new drug applications (ANDAs). Drugs compounded in outsourcing facilities must comply with CGMP requirements, but may be exempted from labeling, approval, and drug supply security chain requirements.
Essentially a copy. Compounded drugs are intended to be used by patients who cannot take commercially available products. The draft guidances state that drugs that are essentially a copy of a commercially available product are not exempt from FDC Act requirements, because such a use poses a significant public health risk. The agency believes that patients taking compounded copies could be needlessly exposed to drug products that have not been proven to be safe and effective. Limitations on compounded copies also protect the drug approval process and preserves competition for sponsors seeking generic drug approval.
The FDA considers a drug to be commercially available if it is currently marketed. Drugs that have been discontinued and are no longer marketed, or drugs that appear on the FDA drug shortage list, are not considered commercially available. To be essentially a copy, a compounded drug would have the same active pharmaceutical ingredients with a similar dosage strength, and used by the same route of administration. These apply unless the prescriber determines that for an identified, individual patient, a significant difference exists in the compounded form.
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