All Eyes On The U.S. Senate Tonight - RxTrace

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Updated November 24, 2025

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Drug Supply Chain Security Act (DSCSA) - FDA.gov

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Hold your breath. Let's see if the U.S. Senate will pass this bill, H.R. 3204 (An act to amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, and for other purposes.)

All Eyes On The U.S. Senate Tonight - RxTrace:

"There are lots of things that would be triggered by passage of the law. No doubt, the most important one is that the California pedigree law would immediately become inoperative. That is, all of the “clocks” in that law—like January 1, 2015 for 50% of all drugs being serialized and pedigreed, etc.—would stop and disintegrate into irrelevance along with those of all other state pedigree laws."

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End game for US medicines traceability bill? - SecuringIndustry.com

Updated Oct 28, 2015:  It passed, and is now enacted. Here's the full text:
Text of the Drug Quality and Security Act (govtrack.us)

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Prospects for the Drug Quality and Security Act (H.R. 3204) are not so promising . . .

SecuringIndustry.com - End game for US medicines traceability bill?:

"Govtrack.us is currently putting the chances of the bill being enacted at 42 per cent. The Congressional Budget Office (CBO) estimates that H.R. 3204 will authorise the collection of $27m in user fees for fiscal years 2014-2018."

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Congress Clarifies Drug Compounding, Tracking Policies

Updated 12/12/2022

The links in the original post broke.

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• Human Drug Compounding - FDA.gov
• Drug Supply Chain Security Act (DSCSA) - FDA.gov

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Congress Clarifies Drug Compounding, Tracking Policies:

"After months of public hearings and negotiations, Democrat and Republican leaders of the House Energy & Commerce Committee and the Senate Health, Education, Labor and Pensions Committee unveiled a compromise bill last week. No one gets all they wanted from H.R. 3204, the Drug Quality and Security Act, but it provides more clarity and predictability to drug oversight programs and moves forward initiatives designed to enhance the safety and quality of medicines in the US."

Follow this link to the draft bill, Drug Quality and Security Act (PDF)

Return Home:  The Designated Representative and Exemptee Blog

- - -

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute