Pharmacists Receive Four-Month Reprieve From Track-and-Trace Regulation

The FDA is offering a four-month grace period to retail and hospital pharmacies that do not act as wholesale distributors to electronically exchanged drug transaction information.

The pharmacists were to begin gathering the information on July 1, but the delay pushes the start date to Nov. 1, according to the final guidance “DSCSA  Implementation: Product Tracing Requirements for Dispensers —Compliance Policy.”

The FDA issued a similar four-month delay for enforcement of its track-and-trace regulations for drugmakers, promising it would take no action until May 1 under the 2013 Drug Quality and Security Act.

According to the guidance, some pharmacists were concerned that their electronic systems would not be up and running on time. This new delay does not extend to drugmakers, wholesalers and repackagers, which all fall under the May 1 deadline.

Read the guidance here www.fdanews.com/07-07-15-trackandtrace.pdf. — John Bechtel