Committee calls for Senate action on updated compounding bill

July 29, 2013

The U.S. Senate Health, Education, Labor and Pensions (HELP) Committee called for the Senate to act on its bill to provide clear oversight of compounding manufacturers, following the 2012 fungal meningitis outbreak, and to protect the U.S. drug supply chain from counterfeiting and theft, according to a HELP Committee statement on July 25.

The U.S. Senate Health, Education, Labor and Pensions (HELP) Committee called for the Senate to act on its bill to provide clear oversight of compounding manufacturers, following the 2012 fungal meningitis outbreak, and to protect the U.S. drug supply chain from counterfeiting and theft, according to a HELP Committee statement on July 25.

 The updated legislation, S. 959, known as the “Pharmaceutical Quality, Security, and Accountability Act,” includes the “Pharmaceutical Compounding and Quality and Accountability Act” (Title 1) and the “Drug Supply Chain Security Act” (Title 2).

Under Title 1, the bill distinguishes between traditional compounding for humans that will continue to be regulated by state boards of pharmacy and compounding manufacturers that will be regulated by FDA. Compounding manufacturers are defined as manufacturers that produce sterile products without, or in advance of, a prescription and then sell across state lines.

Title 1 still allows traditional compounding pharmacies to compound for healthcare practitioners for office use, but sets the limit to 10% of products that the compounding pharmacy can dispense. Within 14 days of dispensing, the pharmacies must reconcile the names of patients who will receive the office use product, the HELP Committee noted.

FDA will be able to develop a list of drugs that cannot be compounded and bulk ingredients that cannot be used in compounded products. Also, there is be streamlined notice for compounding during a drug shortage, which allows for a single notice by the compounder that is copying an FDA-approved drug, according to Title 1.

Compounding manufacturers will only be able to compound nonsterile drugs from a list developed by FDA. However, they will be allowed to repackage biologics without a prescription. All compounding manufacturers will be listed on the FDA’s website, including the state where they are registered. When compounding manufacturers register, they must include a list of products that they produced in the last 6 months.

“This bill is about saving lives, plain and simple. The most recent compounding outbreak resulted in 61 deaths. More than 700 people continue to suffer from tainted compounded medicine. We must find reasonable ways to prevent further death or illness due to confusion over who has oversight of compounding pharmacies,” said Sen. Pat Roberts (R-Kan.) during the release of this updated bill.

Under Title 2, within 4 years of enactment of this legislation, all prescription drugs will be tracked from the manufacturer to the pharmacy. Manufacturers will have to serialize their products, provide transaction information, transaction history, and transaction statements in an electronic format to their trading partners.

“This bill establishes a uniform system that improves the security and safety of drugs for consumers,” Sen. Richard Burr (R-N.C.) said during the release of the updated legislation.