On May 18, 2015, the Food and Drug Administration posted "From our Perspective" providing materials for dispensers subject to the November 2013 Drug Supply Chain Security Act (DSCSA). The FDA's website was recently updated with a copy of a webinar and PowerPoint presentation entitled Know Your Source posted by the FDA's Division of Drug Information (DDI). The FDA materials appear intended to be consumer friendly rather than aimed at a more sophisticated audience looking for regulatory solutions. Nonetheless, with these materials, FDA has provided a digestible exposé of Congress' 10-year roll out of the plan to restructure federal requirements for supplying and distributing finished dose prescription drugs in the U.S. You can learn more about what the law means to you as a dispenser and have the opportunity ask questions by attending the Strasburger "Dispensers" DSCSA Compliance Webinar on June 9, 2015.
The FDA also posted a list of recent enforcement actions and letters to physicians, identifying the physicians whom it believes "may have obtained counterfeit or unapproved drugs from a rogue distributor." While there are important exemptions for physicians under the DSCSA, the FDA's posting the identities of the physicians and listing criminal prosecutions should serve as a caution to all dispensers—including physicians—that adulterated, misbranded, counterfeit, substandard, fraudulent, unapproved or diverted drug products create significant risk to the public health and present serious potential for civil and criminal liability.
The requirements for manufacturers, distributors and repackagers providers have begun and as of July 1, 2015, dispensers are prohibited from accepting ownership of a product, unless their supplier provides specific and detailed information.
What is a dispenser and what are the requirements? The term "dispenser" is not defined in the Food Drug and Cosmetic Act, but the DSCSA defines "dispenser" to mean "a retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor... and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor..." Pharmacies, including hospital pharmacies, are subject to the same requirements as their upstream trading partners including manufacturers, distributors and repackagers.
Beginning July 1, 2015, "dispensers" are required to comply with the product tracing requirements. Those requirements do not permit a dispenser to accept or transfer ownership of a finished-dose prescription drug from an "authorized trading partner" unless it has received or provides detailed information required for the Transaction History (TH), Transaction Information (TI) and Transaction Statement(TS). The dispenser may contract with its distributor to maintain the TI, TH and TS but will remain responsible and must provide the information to federal or state official within two days of a request. Also beginning January 1, 2015, dispensers must have a verification system in place to identify, investigate, dispose, notify and keep records for "suspect" and "illegitimate" products.
Are Physicians subject to the DSCSA requirements? The definition of dispenser under the DSCSA encompasses "any other person authorized by law to dispense or administer prescription drugs..." 21 USC 360eee(3). Thus, the term dispenser includes physicians who dispense and administer prescription drugs. While the DSCSA purports to bring the "dispensing" physicians into the scope of the new and stringent requirements, last-minute legislative wrangling provided an exception from the requirements for collecting and retaining Transaction Information, Transaction History and Transaction Statement as well as the Verification requirements for "licensed health care practitioners." 21 USC 360333-1(d)(5).
This means physicians who administer prescription medications in the usual course of their medical practice are required to transact only with authorized trading partners who must in turn comply with the DSCSA. It is not feasible for dispensers, including physicians, to anticipate and protect against all evolving methods that criminals use to get illegal drugs in the drug supply chain, but having defensible procedures in place is an important first step. Protecting your customers and patients as well as providing a response to state or federal regulators may help ensure your name is not on the next FDA posting.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.