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As you are already well aware, the FDA is long overdue to publish four different guidance documents covering various aspects of the
Drug Supply Chain Security Act (DSCSA), as mandated by Congress (see “ Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”). At least two of those guidance documents would affect how companies should expect to comply with the serialization deadline on November 27, 2017.
If the FDA doesn’t publish on or before that date, does that mean you don’t need to comply on time? Can you just sit back and wait for the FDA to post those guidance documents someday? I don’t think so. Here’s why.
Continue reading InBrief: Why The DSCSA Will Be Enforced Even Without FDA Guidance
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
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Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.
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