WASHINGTON — The Healthcare Distribution Management Association (HDMA) is praising the Food and Drug Administration for its flexibility pertaining to new product tracing rules, specifically on the FDA’s recently released guidance titled “Product Tracing Requirements — Compliance Policy.”
The association had sent letters to the regulatory agency in November and then again last month in which it sought enforcement discretion when evaluating the supply chain’s compliance with the Drug Supply Chain Security Act (which was signed into law in November 2013) data requirements that went into effect on January 1.
The rules related to the tracing of certain prescription drugs impact dispensers beginning in July.
“HDMA applauds FDA’s decision to apply enforcement discretion as the supply chain works to implement the product tracing requirements of the DSCSA. FDA’s action is responsive to HDMA’s concerns and reflects the ongoing collaboration between the agency and distributors, manufacturers and dispensers to implement the DSCSA as effectively and efficiently as possible with minimal supply chain disruption,’’ said HDMA senior vice president of communications John Parker.
“HDMA and our primary distributor members look forward to continuing our work with the FDA to strengthen the pharmaceutical supply chain and ensure patients have access to the medicines they need, when they need them.”
According to the FDA, it does not intend to take action against manufacturers, distributors and repackagers that, before May 1, fail to provide or capture “transaction information, transaction history and transaction statement” under the Food, Drug and Cosmetic Act.
“Guidance documents do not typically establish legally enforceable responsibilities. Guidances describe the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited,’’ says the FDA. “The use of the word ‘should’ in agency guidances means that something is suggested or recommended, but not required.”