Tag Archives: regulations

Two-For-One FDA Guidance Docs

Back in February I noted the steep drop in public inspection documents posted by the FDA immediately after President Trump took office (see “One Immediate Impact of President Trump On The FDA”).  For that essay I created a graph that clearly showed the steep drop.  But that was only one month after the new President took office.  What has happened since then?  This week I updated my graph so we can see how things are progressing.  Continue reading Two-For-One FDA Guidance Docs

One Immediate Impact of President Trump On The FDA

Most RxTrace subscribers are aware that the FDA is way overdue to publish four guidance documents mandated by the Drug Supply Chain Security Act (DSCSA) (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?” and “Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?” for a list of the missing documents).  Two of those four documents could impact how some drug manufacturers deal with the November 27, 2017 deadline for full serialization of prescription drug products, depending on what the FDA says in them. 

Every day since the original due date of those documents (November 27, 2015) I have Continue reading One Immediate Impact of President Trump On The FDA

Brazil Suspends Pharma Serialization And Tracing Requirements

ANVISA logoLast week, Brazil’s pharma industry regulatory agency, the National Agency of Sanitary Surveillance (ANVISA), announced that they were “suspending” at least part of RDC-54/2013, the declaration that mandated drug serialization and tracing, until further notice.  Thank you to all who forwarded the link to the official announcement.  I was able to translate and read it on Thursday, and I submitted a comment on my own last essay, “Pharma Serialization Deadlines In Flux“, to include the link.  Apparently shortly after that essay was published, ANVISA  Continue reading Brazil Suspends Pharma Serialization And Tracing Requirements

The Differences Between The DSCSA, FDA Rules and Guidance

???????????From reading the responses to the FDA docket requesting public feedback on standards for interoperable information exchange, I think it is time to review the difference between laws, FDA Rules and FDA guidance, like those stemming from the Drug Supply Chain Security Act (DSCSA).  It appears that some people might be confusing these a little.

Dr. Connie Jung, RPh, PhD, Acting Associate Director of Policy and Communications, in the Office of Drug Security, Integrity and Recalls, in the Office of Compliance within the U.S. FDA Center for Drug Evaluation and Research, helped put it all into perspective for me.  During one of the breaks at the recent FDA DSCSA Workshop (see “The 2014 FDA DSCSA Workshop“)  I asked Dr. Jung what the odds are Continue reading The Differences Between The DSCSA, FDA Rules and Guidance

Hey California Board of Pharmacy: Your Time Is Running Out!

wicked witch hourglassImportant Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.The California Board of Pharmacy has begun to hold ePedigree-specific meetings with staff and a subset of the Board present.  The first of these occurred on Monday of this week.  The agenda was fairly long and promised action on a number of important topics, including the possibility that the Board would consider the use of EPCIS as a pedigree platform, inference, pedigree certifications and drop shipments.  I came away disappointed that the only thing that happened was a brief discussion of each topic but seemingly no real action.  It was almost as if the Board members and staff had made no progress on any of these topics since the March Enforcement Committee meeting.  All that seemed to happen since that meeting Continue reading Hey California Board of Pharmacy: Your Time Is Running Out!