Proposed Legislation Targets Specialized Compounding Pharmacies

Published on: 06.07.2013

As reported by the Washington Post recently, the Senate Health, Education, Labor, and Pensions Committee, approved a bill that would define a new category of regulation by the Food and Drug Administration (FDA) for specialized pharmacies. Specifically, proposed legislation will distinguish between traditional compounding pharmacies and specialized compounding pharmacies. The bill was written after tainted vials of injectable steroids, produced and distributed by a specialty compounding pharmacy in Massachusetts, caused a fatal meningitis outbreak last fall. 

While traditional compounding pharmacies customize drugs and doses according to individual prescriptions, specialized compounding pharmacies like the one in Massachusetts, blend specialty pharmaceuticals without a prescription. These formulations are not available through conventional means and fall outside the scope of FDA regulations. Many argue that specialized compounding pharmacies have developed operations similar to those of a large drug manufacturer, shipping their products nationwide. Under the proposed legislation, such companies would be required to register with the FDA and therefore be subject to regular inspections.

Some argue that the bill has been too narrowly defined. Because it includes only those companies that make and sell sterile products across state lines, it is anticipated that some large companies will be able to fly under the radar. Companies considered exempt from FDA scrutiny would include those who manufacture oral and topical medicines or who only sell within their own state. Those not in favor of the bill as it is written, assert that without regulating oral drugs and topical creams and gels, tainted products (such as some chemotherapy drugs) will still make it into consumer hands. Furthermore, they argue defective injectables will still cause harm within state lines.

Traditional pharmacies understand best compounding practices for creating safe products. Part of responsible compounding includes the use of an accurate and reliable digital scale, such as the DRX-3. The DRX-3 is highly regarded in the industry as a "teaching scale" and includes important features such as a filling meter and recipe archiving.

All of our scales are NTEP certified and meet all pharmacy state board requirements. Contact us today to find the best products for your needs.