- appear on an FDA pre-approved list (the Bulk Drug list);
- have a USP monograph; or
- be a component of an approved drug.
Action Alert! Representative Morgan Griffith (R-VA) has reintroduced a bill to ensure continued consumer access to customized natural medicines made at specialized pharmacies (known as compounding pharmacies). While other challenges remain, the Preserving Patient Access to Compounded Medications Act is an important step toward curbing the attack on these important natural medicines. The Act does several important things. It amends section 503A of the Food, Drug, and Cosmetic Act (which pertains to “traditional” pharmacies, as opposed to larger “outsourcing” facilities) to unequivocally permit “office use” of compounded drugs, which allows a doctor to keep a supply of certain medications in his or her office in order to provide immediate treatment to patients who need it. For example, without office use, a patient in extreme pain would have to wait for days, get his or her prescription filled, and then return to the doctor for an injection. The bill also mandates the FDA to accept USP monographs for dietary supplements. This is a pivotal issue. In order to be made into a customized medicine, a substance has to meet one of three criteria. It must either: