Congresswoman DeLauro (D-CT) and Congresswoman Lowey (D-NY) introduced legislation on drug compounding this week. Among other provisions, the Supporting Access to Formulated and Effective Compounded Drugs Act of 2012 would:
· Notice to Patient: Require pharmacists to confirm with the patient that they are aware that the drug is compounded and to provide a written document to the patient concerning the availability, safety, and production of the compounded drug;
· Registration with FDA: Require compounding pharmacies to register with the FDA and submit contact information, identify the State or States the pharmacy is licensed in, the methods of compounding used, and any additional info the Secretary requires UNLESS the pharmacy meets the exception. The exception from the requirement to register is if the pharmacy employees fewer than 20 full-time employees AND performs traditional compounding of drug products for use in a single State.
· Labeling: A compounded drug must be labeled as “non-FDA approved compounded drug product.” In addition, the legislation mandates the Secretary to establish and consult with a temporary advisory committee on compounded drug product labeling requirements and allows the Secretary to establish different labeling requirements for compounded drugs intended for use by a health care provider in an office or treatment setting and all other compounded drugs.
NCPA will continue to monitor this issue and work with Congress to provide valuable insight into the role that compounding plays in providing access to care for beneficiaries.