Both the National Association of Chain Drug Stores (NACDS) and the National Community Pharmacists Association (NCPA) have endorsed The Drug Quality and Security Act, with letters to Congress to approve the legislation that was introduced September 26. The bill’s two major provisions are expected to address high-risk compounding practices and help to secure the pharmaceutical supply chain.
Both the National Association of Chain Drug Stores (NACDS) and the National Community Pharmacists Association (NCPA) have endorsed The Drug Quality and Security Act, with letters to Congress to approve the legislation that was introduced September 26.
The bill’s two major provisions are expected to address high-risk compounding practices and help to secure the pharmaceutical supply chain. The bill is the result of a bipartisan group of Senate Health, Education, Labor, and Pensions (HELP) Committee senators, which includes Chairman Tom Harkin (D-IA), Ranking Member Lamar Alexander (R-TN), Senator Al Franken (D-MN), Senator Pat Roberts (R-KS), Senator Michael Bennet (D-CO), and Senator Richard Burr (R-NC).
Under Title 1, “compounders who wish to practice outside the scope of traditional pharmacy practice can register as outsourcing facilities,” and would be subject to FDA oversight like drug manufacturers. FDA will have a list of outsourcing facilities and know exactly what compounding products they are making. FDA will be able to conduct risk-based inspections of these facilities. FDA will list these outsourcing facilities on its website, which can be accessed by providers and patients. Both providers and patients can decide if they want compounding products from outsourcing facilities that are regulated by FDA.
Also, under Title 1, “the legislation strikes unconstitutional provisions in current law, resolving the patchwork of current federal regulation and applying a uniform standard nationwide.”
“NCPA commends Congress for crafting bipartisan legislation that addresses the New England Compounding Center (NECC) tragedy, ensures quality standards for all compounded pharmaceuticals, and maintains patient access to vital compounded medications,” said NCPA CEO B. Douglas Hoey, RPh, MBA, in his letter to lawmakers.
Under Title II, track and trace legislation with a uniform standard that provides a pathway to unit-level tracing in a decade, is expected to improve patient safety and replace state product tracing laws. “Within 10 years, supply chain stakeholders will participate in electronic, interoperable product tracing,” according to a press statement.
In addition, licensure requirements for wholesale distributors and third-party logistics provides will be strengthened. FDA will develop a database of wholesalers and post on its website for public access. Within 4 years of passage, the Act requires manufacturers to serialize drugs consistently nationwide. This will allow for quick response to recalls, theft notices, and counterfeited products.
“Chain pharmacy has made significant investments to ensure that the U.S. pharmaceutical distribution system is one of the safest in the work and your legislation will only improve and strengthen the process for all stakeholders,” NACDS said in a letter to congressional leaders about the legislation.