Search Results for: enforcement discretion

Dispensers, DSCSA

FDA Limits Ongoing Dispenser Enforcement Discretion To First Responders

Back in October the FDA announced the extended use of enforcement discretion to temporarily set aside the data exchange provisions of the Drug Supply Chain Security Act (DSCSA) for dispensers until March 1, 2016 (see “FDA Extends Dispenser Delay in DSCSA Enforcement“).  That was itself an additional four month extension to the four month enforcement … Continue reading FDA Limits Ongoing Dispenser Enforcement Discretion To First Responders →

DSCSA

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?

DSCSA

FDA Extends Dispenser Delay in DSCSA Enforcement

3 Comments

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 Guidance

FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1

3 Comments

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 →

DSCSA, HDA, PDG

2 Organizations You Need to Join to Get Ready for the DSCSA Phase II

If you are a pharmaceutical company serious about meeting the requirements of Phase II of the DSCSA, there are two organizations you must join.  The first is the Partnership for DSCSA Governance, or the PDG. It is an organization formed by manufacturers, wholesalers, dispensers, and solution providers that are working to solve the interoperability requirements … Continue reading 2 Organizations You Need to Join to Get Ready for the DSCSA Phase II →

COVID-19, DSCSA, FDA

Impact of COVID-19 on DSCSA Implementation

2 Comments

Before the pandemic struck, the pharma industry was working feverishly to implement and enforce all the requirements of the DSCSA, especially the Phase II requirements scheduled for November of 2023. When COVID-19 dramatically changed the business landscape, the implementation became even more of an uphill battle, with both time and the pandemic acting as a … Continue reading Impact of COVID-19 on DSCSA Implementation →