e-Profile Login and ID Quick Search
Missouri News: Compounding Issues
Published in the May 2006 Missouri Board of Pharmacy Newsletter
4 CSR 220-2.400(9) prohibits the compounding of drugs that are essentially copies of commercially available products. There must be sufficient documentation within the prescription record of a specific medical need for a compounded variation of a commercial product. Essential copies may include different dosage forms (suspension vs solution; tablet vs capsule). Sufficient documentation is considered a prescription from the prescriber indicating the medical need or a notation indicating verbal authorization was obtained. The notation should include the name of the person giving such authorization, the date, and the specific medical need given. The notation can be on the hard copy prescription or stored electronically in the pharmacy as long as it is readily retrievable. A specific medical need is considered the medical reason why the commercially available product cannot be used. Economic or convenience reasons do not suffice. 4 CSR 220-2.400(12) allows a pharmacy to advertise concerning the provision of compounding services; however, specific claims about compounded drugs are not considered to be legal. As an example, a pharmacist cannot claim that a compounded product is “slow release” without analytical data specific for each product to support such claims. A pharmacy cannot rely on data obtained from other sources but must produce data for their specific product. Kits are now available that contain the ingredients needed to compound certain products. The use of these kits is considered compounding and compliance with compounding regulations is required. These kits are not considered to be “commercially available” in reference to CSR 220-2.400(9) above. The mixing of ingredients of a Food and Drug Administration-approved drug product (BenzaClin®, Sulfacet-R®, Benzamycin®, etc) is not considered compounding and compounding regulations would not apply in these instances.
