Search Results for: enforcement discretion

FDA Guidance

FDA DSCSA Deadline Passes Quietly

Last Friday was the deadline for the FDA to publish four new guidance documents under the Drug Supply Chain Security Act (DSCSA) (see “Decoding The FDA’s DSCSA Timeline”).  The deadline was established by the U.S. Congress when they enacted the legislation and it was signed by President Obama on November 27, 2013 (see “It’s Official, … Continue reading FDA DSCSA Deadline Passes Quietly →

Dispensers, DSCSA

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, DSCSA

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 →

DSCSA, FDA, HDMA

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 →

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? →

DSCSA, FDA

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 →