Pharmacists Associations Petition FDA to Utilize Enforcement Discretion as July 1 Deadline for Product-Tracing Compliance Nears

By Andrew J. Hull* - 

On June 22, three major pharmacists associations signed a letter to FDA asking the agency to use its enforcement discretion as pharmacies struggle to create appropriate product-tracing policies and practices before the July 1 compliance deadline under the Drug Supply Chain Security Act (“DSCSA”).  See FDCA § 582(d)(1)(A) (necessitating dispensers to comply with the DSCSA’s product-tracing requirements by July 1, 2015).  In the letter, representatives from the National Community Pharmacists Association (“NCPA”), the American Pharmacists Association (“APhA”), and the National Alliance of State Pharmacy Associations (“NASPA”) claimed that, while their organizations are striving to educate their members on the new law and to help them implement proper policies ahead of the deadline, many pharmacies are still inadequately prepared to comply with the product-tracing requirements.

Specifically, the organizations state that according to a survey of NCPA members, only half of the survey respondents have even been in contact with their wholesale distributors regarding how transaction information would be provided, and many were unaware of services provided by wholesale distributors to maintain and store information.  Additionally, less than 20 percent of respondents were aware of services provided by secondary wholesalers to maintain and store transaction information.

The organizations also expressed concern that the DSCSA does not require secondary wholesalers to provide dispensers with the necessary lot number information in a single document.  Because several secondary distributors have noted their intention to only provide this information on the individual bottles of medication, the organizations claim that pharmacies may be unable to comply with the DSCSA’s record retention requirements.

Referencing FDA’s December 24, 2014 guidance document stating that the agency would not enforce the DSCSA’s product-tracing requirements as they apply to manufacturers, distributors, and repackagers (set to take effect on January 1, 2015) prior to May 1, 2015 (see our previous post here), the organizations request FDA to use similar enforcement discretion by delaying the July 1 deadline for dispensers.  Arguing that such a delay in enforcement is necessary “to forestall potential disruptions in the pharmaceutical supply chain,” the organizations state that their members would continue to make “intense, concerted efforts toward full compliance.”

It will be interesting to see if FDA responds to these concerns even at this late date.  It did so before: FDA’s notification of enforcement discretion of the January 1, 2015 compliance deadline came only 8 days prior on December 24, 2014, right in the middle of the holiday season.  We suspect this decision will be based on whether FDA agrees that the industry still needs more time to implement these standards.  The efforts of these organizations to educate and inform their members should, however, provide FDA with assurance that the industry is taking the DSCSA’s product-tracing requirements seriously.

We will be closely watching to see if FDA releases any notification or guidance as the July 1 deadline approaches.

*Admitted only in Virginia. Work supervised by the Firm while D.C. application pending.