Facing pressure from stakeholders and technological realities, the U.S. Food and Drug Administration has again delayed its enforcement of parts of the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post, the DSCSA requires enhanced security and accountability for prescription drugs throughout the U.S. pharmaceutical supply chain, with phased-in obligations for the various trading partners over 10 years, beginning with the law’s passage in November 2013. Covered trading partners include manufacturers, repackagers, wholesale distributors, and dispensers, whose upcoming compliance obligations under the DSCSA are all addressed by FDA in the recently issued Compliance Policy guidance document. Continue Reading FDA Delays Enforcement of Prescription Drug Product Identifier and Related Requirements
On June 30, 2015, a mere day before the product tracing deadline for dispensers was to go into effect, FDA published a compliance policy guidance that delays enforcement of the applicable product tracing requirements until November 1, 2015 (Compliance Policy). As we previously discussed, pursuant to the Drug Supply Chain Security Act, most pharmacies in the U.S. are required to have systems in place by July 1, 2015, to receive so-called “3T information” (that is, Transaction History, Transaction Statement, and Transaction Information) regarding the prescription drugs they purchase from suppliers.
In the Compliance Policy, FDA notes that dispensers have expressed concern that electronic systems used to exchange, capture, and maintain product tracing information will not be operational by the original July 1 deadline. Although the agency acknowledges that paper-based transmission may be acceptable in some cases, FDA also notes that many dispensers intend to utilize electronic systems to capture and maintain the 3T information. Accordingly, the Compliance Policy concedes that dispensers may need additional time beyond July 1, 2015 to work with their trading partners to ensure that the 3T information is captured and maintained as required by the DSCSA.
Consequently, FDA does not intend to take action prior to November 1, 2015, against dispensers who, in either case: (i) accept ownership of a covered drug product without receiving the 3T information; or (ii) do not capture and maintain the 3T information provided by the dispenser’s trading partner. Continue Reading FDA Provides 11th Hour Delay of Product Tracing Requirements for Pharmacies
Beginning July 1, 2015, most pharmacies in the U.S. will be required to have systems in place to receive transaction information regarding the prescription drugs they purchase from suppliers. The requirement stems from a 2013 federal law called the Drug Supply Chain Security Act (DSCSA), enacted as one component of the Drug Quality and Security Act. In addition to accepting the so-called “3T” information (Transaction History, Transaction Statement, and Transaction Information) for each prescription drug it purchases on or after July 1, covered pharmacies also must have systems in place to segregate and investigate suspect products.