FDA issues a guidance saying it would not take enforcement action until November
The Food and Drug Administration issued a guidance yesterday saying it would not take enforcement action until November against a pharmacy that receives any drug product without also receiving the tracing information. However, as of today, pharmacies are responsible for transmitting tracing documentation to purchasers of their drugs, when required to do so under the DSCSA.
The act, which was signed into law in 2013, helps ensure that the drug supply chain is secure from the point of manufacture through to the point at which pharmacies dispense drugs. Implementation of the law has been ongoing over the past year and half. Starting today, pharmacies were to be required to only accept drugs that were shipped with corresponding tracing documentation.
While drug chains worked hard to achieve DSCSA compliance by the deadline, the National Association of Chain Drug Stores requested enforcement discretion from the FDA on two drug product categories — 340B drugs and drop shipment drugs — to help ensure that patients were not delayed in receiving much-needed medications.
Because of the structure of the 340B program, in many instances a wholesaler will send the 340B drug to the pharmacy and send the tracing documentation to the health care entity. This undermines the intent of the DSCSA to require both the drug product and the tracing documentation to flow together through the supply chain.
While manufacturers of drop shipment drugs can send tracing data directly to the pharmacies, progress has been slow in developing an electronic method for transmission. Electronic transmission is critical for pharmacies because the DSCSA requires pharmacies to have such data readily available in case the FDA needs to investigate possibly illegitimate drug products.
“Pharmacists appreciate and support the FDA’s decision … which will help protect patients from disruptions in access to prescription drugs that may have otherwise and inadvertently occurred,” said B. Douglas Hoey, chief executive officer of the National Community Pharmacists Association (NCPA). “Due to circumstances beyond their control, many pharmacies would have had difficulty complying with the July 1 statutory deadline. The FDA’s latitude should hopefully allow pharmacies to continue to work with their wholesaler partners in order to achieve compliance with new product tracing requirements intended to enhance the safety of the U.S. pharmaceutical system.
“We appreciate the partnership among organizations and companies representing pharmacists, pharmacies, wholesalers and other supply chain entities to educate FDA on industry dynamics and to continue moving forward with smooth implementation of this legislation,” added Hoey. “NCPA will continue to monitor this issue and support community pharmacists’ efforts to make the law a success.”