Track-and-trace law: 2015 deadlines for new requirements
Key dates are January 1 and July 1
January 1 and July 1 are key deadlines in 2015 for new requirements for pharmacists under the Drug Supply Chain Security Act—the track-and-trace part of the compounding and track-and-trace legislation known as the Drug Quality and Security Act and signed into law in 2013.
The requirements under the track-and-trace law are for the entire supply chain. “It’s a shared responsibility and team effort,” said Diane Darvey, PharmD, JD, Director of Federal and State Public Policy for the National Association of Chain Drug Stores. “Pharmacists play an important role in that.”
January 1, 2015
By January 1, 2015, dispensers (primarily pharmacies) must establish systems for verification and handling of suspect or illegitimate product, according to the FDA website. The agency published a related draft guidance in June 2014.
The verification requirements include quarantine and investigation of suspect product to determine if it is illegitimate, and notification of FDA and immediate trading partners if illegitimate product is found.
“The pharmacy must develop a standard operating procedure outlining what pharmacy personnel should do when unpackaging received drug orders,” said Michael H. Ghobrial, PharmD, JD, APhA Associate Director of Health Policy. For example, procedures should be set in place outlining the pharmacy’s role in analyzing each drug product container to search for red flags, he said. If a suspicious product is found, it must be quarantined while determining whether the suspicious product is, in fact, illegitimate. The pharmacy must notify immediate trading partners and FDA if the product is found to be illegitimate.
Also by January 1, 2015, dispensers must confirm that trading partners (manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers) are authorized, as defined by the Food, Drug & Cosmetic Act. FDA suggests checking with trading partners directly to confirm they are authorized, or checking the agency’s drug establishment registration database or the respective state authority to confirm licensure.
July 1, 2015
By July 1, 2015, dispensers must be able to provide lot-level product tracing information—namely, transaction information, history, and statements—for 6 years. Such information may be requested by FDA or an appropriate state regulatory authority. (By January 1, 2015, manufacturers, repackagers, and wholesale distributors must provide lot-level product tracing information.) FDA published a related draft guidance in November 2014.
“Come July 1, pharmacies can’t accept product unless the paperwork’s in the tote,” said Ghobrial.
Whereas large chains with the electronic infrastructure for ordering and inventory management are further along the path where electronic storage of this information would be easier, many independent pharmacies don’t have electronic inventory management or ordering systems and often use paper invoices, he said. “We as an industry are moving towards electronic transmission of the product tracing information,” Darvey said.
Although the big three wholesale distributors will provide online portals for pharmacies to access the information, independent pharmacies also may often contract with the small regional distributors that in many cases give pharmacies their start. These pharmacies now should be seeking to enter into agreements with their distributors to maintain transaction information, history, and statements on their behalf and to give access to the information, including lot-specific information. This is because pharmacies would be overburdened if they had to independently capture and store this information because of space if it’s paper, and because of lack of infrastructure if it’s electronic, Ghobrial said.
While this is not something wholesalers are required to do and secondary wholesalers “span the gamut” in terms of technological savvy, wholesalers have to keep track of the information anyway so “it makes sense for the industry to work together,” said Susan Pilch, JD, Vice President of Policy and Regulatory Affairs with the National Community Pharmacists Association.
It is still unclear whether all pharmacies—community and hospital—are required to step into the shoes of a distributor and ship transaction history, statements, and information when transferring drugs between pharmacies, Ghobrial added, noting that FDA has said it will issue guidance on that. “This is a major concern because many pharmacies borrow inventory from each other, especially in rural areas where shipments from distributors may be infrequent and a patient is in imminent need of the medication.”