As Supply Chain Partners Ramp Up For November DSCSA Deadline, US FDA Gives Them Another Year - Pink Sheet

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Read the full text of the source article, so you can be sure about what is included and excluded from the one year delay in enforcement action.

According to the article:

"The US Food and Drug Administration has given pharmaceutical distribution trading partners an extra year to comply with package-level Drug Supply Chain Security Act product tracing requirements that take effect 27 November [2023] before it starts enforcing them."

Source Article:  As Supply Chain Partners Ramp Up For November DSCSA Deadline, US FDA Gives Them Another Year -  Pink Sheet

Go to the FDA Guidance:  Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies - FDA.gov

6 Things We Need From FDA Before Full 2023 DSCSA Enforcement - BioProcess Online

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According to the article:

"The journey to industry compliance with the U.S. Drug Supply Chain Security Act (DSCSA) continues to twist and turn with recent requirements going into effect for distributors and dispenser and subsequent delays on enforcement of some of those requirements until Nov. 27, 2023."

"The discussions and perspectives in the meeting were often conflicting and sometimes seemed to ignore insights developed over the past years by several industry workgroups. We would like to suggest some concrete actions the FDA can take now to help bring together a complex and diverse number of sectors in advance of 2023 enforcement:"

Read the full source article:  6 Things We Need From FDA Before Full 2023 DSCSA Enforcement - BioProcess Online

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Justice Department and Federal Partners Announce Enforcement Actions of Dietary Supplement Cases | OPA | Department of Justice

Read the full press release: Justice Department and Federal Partners Announce Enforcement Actions of Dietary Supplement Cases | OPA | Department of Justice:

"Criminal Charges Brought against Bestselling Supplement Manufacturer

As part of a nationwide sweep, the Department of Justice and its federal partners have pursued civil and criminal cases against more than 100 makers and marketers of dietary supplements.  The actions discussed today resulted from a year-long effort, beginning in November 2014, to focus enforcement resources in an area of the dietary supplement market that is causing increasing concern among health officials nationwide.  In each case, the department or one of its federal partners allege the sale of supplements that contain ingredients other than those listed on the product label or the sale of products that make health or disease treatment claims that are unsupported by adequate scientific evidence.

Among the cases announced today is a criminal case charging USPlabs LLC and several of its corporate officers.  USPlabs was known for its widely popular workout and weight loss supplements, which it sold under names such as Jack3d and OxyElite Pro."

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Warning Letters (2012 – Q1 2014) Show FDA’s GMP Enforcement Shifting Overseas | IPQ Newsletter

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Warning Letters from 2012 – Q1 2014 Show FDA’s GMP Enforcement Focus Shifting Overseas; Foreign Labs Draw Particular Attention | IPQ Newsletter:

"In 2012, for the first time, foreign warnings began outpacing those issued domestically. Between 2012 and the first quarter of 2014, 48 drug GMP warning letters were issued internationally compared to 44 in the U.S. [Editor's Note:  At the end of the story is a chronological listing of all 92 of the drug GMP warning letters issued between the beginning of 2012 and the first quarter of 2014, categorized into U.S. and International. The key concerns that each of the warning letters address and links to the letters themselves are provided.]"

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