US Senate Committee Proposes Legislation to Create Compounding Manufacturer Category to Be Under FDA Regulation

Federal lawmakers have drafted legislation that would create a new category of drug compounders, “compounding manufacturers,” to be regulated by Food and Drug Administration (FDA). Traditional compounding pharmacies that prepare patient-specific medications pursuant to an individual prescription would continue to be licensed and regulated by the state boards of pharmacy, under the proposed law. Entities falling into the category of compounding manufacturer would be required to register with FDA and pay a fee intended to help cover the costs of inspections by the agency, reports NBC. Such entities would not be required to obtain FDA approval for the drugs they prepare, but product labeling must indicate that the drug has been compounded and that the product is “not for resale,” among other labeling requirements. Compounding manufacturers would be prohibited from compounding FDA-approved drugs except under certain circumstances, such as during a drug shortage. NABP submitted comments on the draft legislation in response to a call for comments by the US Senate Committee on Health, Education, Labor, and Pensions (HELP) and will also provide testimony at a HELP Committee hearing on May 9, 2013. In its comments the Association expressed its support of the provisions outlined above, and also noted its concerns with the exemption of intrastate distribution of non-patient-specific sterile compounded products. NABP contends that non-patient-specific sterile prepared products bear the same risks whether such products are introduced into interstate commerce or distributed locally within a state. NABP also indicates its interpretation that under the proposed legislation “for office/clinic use” prepared products without a prescription, or in anticipation of a prescription, would fall into the category of compounding manufacturer if such products are introduced into interstate commerce and compounding if distributed intrastate.