Pay No Attention To The Enforcement Delay Unless You Are A Dispenser

As I reported last Thursday, the FDA published new revised guidance that extends their enforcement delay of the Drug Supply Chain Security Act (DSCSA) data exchange requirements for dispensers by an additional 4 months (see “FDA Extends Dispenser Delay in DSCSA Enforcement“).  What does this mean for drug manufacturers, wholesale distributors and repackagers?

FDA Extends Dispenser Delay in DSCSA Enforcement

Early this morning the FDA published a revised version of its “DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy“, originally published on July 6, 2015 (see “FDA Publishes New Guidance Delaying Dispenser 3T Requirements Until November 1, 2015“).  That original document established the FDA’s intention to exercise “enforcement discretion” on dispenser transactions that … Continue reading FDA Extends Dispenser Delay in DSCSA Enforcement

FDA Publishes New Guidance Delaying Dispenser 3T Requirements Until November 1, 2015

The FDA updated their website this morning with new guidance that indicates they intend to use enforcement discretion by not enforcing the dispenser requirements to accept and capture Transaction Information (TI),Transaction History (TH) and a Transaction Statement (TS) until November 1, 2015, a four month delay in enforcement.  The document indicates that the FDA’s decision to take this action … Continue reading FDA Publishes New Guidance Delaying Dispenser 3T Requirements Until November 1, 2015

Dispensers Make Last Minute Appeal for Delay in DSCSA Deadline

Less than a week before the July 1, 2015 Drug Supply Chain Security Act (DSCSA) deadline for dispensers to begin receiving, storing a being able to retrieve Transaction Information (TI),Transaction History (TH) and a Transaction Statement (TS) for every incoming shipment of prescription drugs, a group of pharmacy associations have asked the FDA for enforcement discretion for an unspecified … Continue reading Dispensers Make Last Minute Appeal for Delay in DSCSA Deadline

FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1

In a direct response to concerns expressed by the Healthcare Distribution Management Association (HDMA) and others (see “HDMA Expresses Concerns About Industry Readiness for DSCSA” and “Will The DSCSA Cause Drug Shortages After January 1?”), the FDA posted new guidance that states their intention to postpone enforcement of just the requirements for manufacturers, wholesale distributors … Continue reading FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1

HDMA Expresses Concerns About Industry Readiness for DSCSA

Last week the Healthcare Distribution Management Association (HDMA), the industry association for the U.S. primary healthcare distributors, published a letter from HDMA President and CEO John M. Gray to the FDA expressing concerns that not all members of the supply chain will be ready to exchange the transaction data mandated by the Drug Supply Chain … Continue reading HDMA Expresses Concerns About Industry Readiness for DSCSA

Will The FDA Delay The DSCSA?

More and more people are asking if the FDA will delay the January 1, 2015 requirements of the Drug Supply Chain Security Act (DSCSA).  On that day, drug manufacturers, repackagers and wholesale distributors must begin exchanging Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS), (dispensers join them next July) and the FDA is … Continue reading Will The FDA Delay The DSCSA?

The 2014 FDA DSCSA Workshop

The U.S. FDA held their first industry workshop focusing on the new Federal Drug Supply Chain Security Act (DSCSA) last Thursday and Friday at FDA Headquarters in Silver Spring, MD.  The goal of the workshop was to help the FDA collect ideas and preferences from industry stakeholders and technology providers for meeting the January 1, … Continue reading The 2014 FDA DSCSA Workshop