FDA Issues Two DSCSA Draft Guidances

• Board-approved California Designated Representative online training programs by SkillsPlus International Inc. | Training courses for wholesalers, 3PL, and reverse distributors.

The FDA issued 2 DSCSA draft guidances:

Date Published	Type	Title
7/05/2022	Draft Guidance	Identifying Trading Partners Under the Drug Supply Chain Security Act
7/05/2022	Draft Guidance	DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry

View the full list of Drug Supply Chain Security Act Law and Policies - FDA.gov

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• The Exemptee Institute

New DSCSA Related Guidance Docs

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According to this FDA In Brief quote by Donald D. Ashley, J.D., Director of the Office of Compliance for FDA's Center for Drug Evaluation and Research:

"Ensuring the quality of prescription drugs and safeguarding the integrity of pharmaceutical distribution are crucial roles the FDA plays in protecting the health of the American public. Illegitimate and unsafe products must be kept out of the U.S. drug supply chain.

Since 2013, when the FDA began phasing in new requirements added by the Drug Supply Chain Security Act (DSCSA), we have helped create a supply chain that is better at preventing and detecting the introduction of illegitimate products. The new requirements can also enable stakeholders and the FDA to respond rapidly when such products are found.

To help our stakeholders understand these requirements, we are issuing guidance documents intended to assist trading partners in complying with the law and achieving a safer, more secure and more trusted drug supply chain. We are also soliciting feedback for further improving the way our drug supply chain operates within the DSCSA framework. We view these guidance recommendations as an important part of implementing the robust enhanced system envisioned under DSCSA.

We look forward to continuing open conversations on DSCSA-related issues and providing future guidance to stakeholders as part of our efforts to protect American patients and the drug supply chain we all rely on."

Read more and see the links to the four (4) newly added guidance documents: 
FDA In Brief: FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chain - FDA.gov

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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

DSCSA Exemption And Exclusion For COVID-19 | FDA Guidance

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Open the complete guidance:  Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency - FDA Guidance (PDF)

According to the guidance document:

"Due to the COVID-19 pandemic, FDA has been monitoring requests related to provisions of the Drug Supply Chain Security Act (DSCSA) because the provisions may affect the prescription drug supply chain during the COVID-19 outbreak. FDA is issuing this guidance to clarify the scope of the public health emergency exemption and exclusion under the DSCSA for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS)" . . .

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California Designated Representative Training Programs - Board-Approved - For wholesalers, 3PL, reverse distributors - Earns a training affidavit

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

Industry Calls for Changes to FDA’s DSCSA Product Identifier Guidance - RAPS.org

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Read the full article:  Industry Calls for Changes to FDA’s DSCSA Product Identifier Guidance - RAPS.org

"The biggest change industry is calling for is for FDA to allow manufacturers to use the GS1 Global Trade Identification Number (GTIN), which typically contains the National Drug Code (NDC) number along with other information, in the human-readable portion of the product identifier in place of the NDC. This request is echoed by the Biotechnology Innovation Organization (BIO), the Association for Accessible Medicines, the Healthcare Distribution Alliance, Bristol-Myers Squibb, Shire and GS1 itself.

In its comments, the BIO also asks FDA to revise the guidance to allow manufacturers more flexibility when it comes to ordering the human-readable portion of the product identifier."

You might also be interested in:
ICYMI: FDA Released Three DSCSA-Related Guidances - Healthcare Packaging

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California Designated Representative Training Courses (wholesaler, 3PL, reverse distributor) - Approved by the California State Board of Pharmacy

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 - New!
• 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

FDA Publishes DSCSA-Related Guidance on Verification Systems

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Updated September 14, 2026

You might also be interested in a collection of the FDA's DSCSA-related guidances, all in one location:

Drug Supply Chain Security Act Law and Policies - FDA.gov

- - - original post follows below - - -

According to this newly published FDA guidance:

Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Guidance for Industry (PDF)

"Certain trading partners (manufacturers, wholesale distributors, dispensers, and repackagers) are required to have verification systems in place" . . .

Background  

Section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1), as added by the Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54), established requirements to facilitate the tracing and verification of certain prescription drug products through the U.S. pharmaceutical distribution supply chain.

FDA is issuing this guidance to describe FDA’s interpretation of the requirements of section 582 of the FD&C Act regarding verification systems. This guidance provides recommendations for a robust verification system for the determination, quarantine, and investigation of suspect products, as well as the quarantine, notification, and disposition of illegitimate products.

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California Designated Representative Training Courses (wholesaler, 3PL, reverse distributor) - Approved by the California State Board of Pharmacy

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

ICYMI: FDA Released Three DSCSA-Related Guidances - Healthcare Packaging

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• California Designated Representative Training (approved by the California State Board of Pharmacy) - Earn a training affidavit.

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Read the full article:   ICYMI: FDA Released Three DSCSA-Related Guidances - Healthcare Packaging

According to the article, the FDA released the following guidances:

1. Product Identifiers Under the Drug Supply Chain Security Act- Questions and Answers Guidance for Industry (PDF)
2. Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier (PDF)
3. Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy (PDF)

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California Designated Representative Training Courses (approved by the California State Board of Pharmacy) - Earn a training affidavit

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

FDA Publishes Long-Awaited Draft Guidance on Waivers, Exceptions, and Exemptions from the DSCSA (FDC Act Section 582) - FDA Law Blog

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Read the entire article:   FDA Publishes Long-Awaited Draft Guidance on Waivers, Exceptions, and Exemptions from the DSCSA (FDC Act Section 582) - FDA Law Blog:

"Pursuant to Section 582, trading partners in the pharmaceutical distribution supply chain must implement over a period of time certain tracking, tracing, and product identification requirements."

'via Blog this'

View the referenced guidance document:
Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act - Guidance for Industry - FDA (PDF)


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Earn a training affidavit  -  Training programs for California Designated Representative license applicants

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 

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 - New!
• 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

Cutting Through the DSCSA Confusion | Healthcare Packaging

The FDA guidance, deadlines, and the role(s) your company play(s), all contribute to the confusion.

Read the full summary:  Cutting Through the DSCSA Confusion | Healthcare Packaging:

"At a Global Track & Trace event held last week in New Jersey, Gordon Glass, Vice President Consulting, Excellis Health Solutions, updated attendees with key insights and important lenses through which to view and interpret the likely-to-be-postponed regulations."

'via Blog this'

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Training program for California Designated Representative license applicants (including 3PL) - Earn a training affidavit

CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
The Exemptee Institute

NEW! CA Designated Representative-3PL online training certification by SkillsPlus Intl Inc.- We'll send you the 3PL training affidavit upon successful course completion.
CA Designated Representative online web-based training certification by SkillsPlus Intl Inc. - Available around-the-clock 24 x 7
FL Certified Designated Representative (CDR) online exam prep course - Lots of practice exams - Practice makes perfect!
The Designated Representative Institute

FDA Offers Draft Guidance to Further Secure Drug Supply Chain

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Updated December 1, 2025

One of the original links broke.

You might also be interested in:

Identifying Trading Partners Under the Drug Supply Chain Security Act - Guidance Document - FDA.gov

---  the original post follows below  ---

Read the full article: FDA Offers Draft Guidance to Further Secure Drug Supply Chain | RAPS:

"Last Friday, FDA released new draft guidance to help industry, state and local governments categorize the entities in the drug supply chain in accordance with the DSCSA and help clarify which companies are engaged in activities that require licensure and annual reporting.

The 18-page draft, titled "Identifying Trading Partners Under the Drug Supply Chain Security Act," notes the confusion related to defining wholesale distributor and wholesale distribution, as well as confusion over what an affiliate of a manufacturer means."

'via Blog this'

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Training program for California drug or device wholesaler license applicants

Training program for California third party logistics (3PL) providers license applicants

- - -

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

DSCSA Enforcement Delay - What It Means for You | Clarkston Consulting

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• Wholesaler Training Course
• 3PL Training Course
• Reverse Distributor Training Course

Read the full article: DSCSA Enforcement Delay - What It Means for You | Clarkston Consulting:

"On June 30, 2017, the FDA published a draft guidance announcing an enforcement delay for the pharmaceutical manufacturer’s requirement under the Drug Supply Chain Security Act (DSCSA). The delay pushes enforcement back a full year from November 27, 2017 to November 27, 2018."

'via Blog this'

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Training program for California Designated Representative license applicants

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

DSCSA Identification of Suspect Product and Notification - FDA Final Guidance

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The FDA released this final guidance:
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification FDA Guidance for Industry (PDF)

In brief:
This guidance identifies specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain; provides recommendations on how trading partners can identify a product and determine whether a product is a suspect product as soon as practicable; and sets forth the process by which trading partners should notify FDA of illegitimate product or products with a high risk of illegitimacy, and how they must terminate the notifications, in consultation with FDA.

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Training for Designated Representative license applicants

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

FDA To Dispensers - Guidance on DSCSA July & Nov Timelines

The FDA published a new guidance:

DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy Guidance for Industry - FDA (PDF)

In a nutshell:

"The product tracing requirements in sections 582(d)(1) of the FD&C Act take effect for
dispensers on July 1, 2015. ... "

"FDA does not intend to take action against dispensers who, prior to November 1, 2015, accept
ownership of product without receiving the product tracing information, as required by section
582(d)(1)(A)(i) of the FD&C Act."

There's a whole lot more in the guidance, so you'll want to review it, in its entirety.

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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

Related articles

• 
  Who Offers Designated Representative Training?

The Differences Between The DSCSA, FDA Rules and Guidance - RxTrace

• California Designated Representative Training Courses for:
       Wholesalers | 3PL | Reverse Distributors
• FDA GMP Training Courses - respected FDA CGMP online training courses provided by SkillsPlus International Inc.

More great stuff that's clear and easy to understand from Dirk Rodgers. Follow the link below to read his full post.

The Differences Between The DSCSA, FDA Rules and Guidance - RxTrace:

"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."

'via Blog this'

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

Related articles

• 
  FDA DSCSA Workshop - Meeting Materials
• 
  FDA Law Blog: Interoperably Exchanging Information with FDA: Agency Holds First DSCSA Public Workshop
• 
  About The HMDR Licensing Program
• 
  Drug Supply Chain Security Act - Drug Supply Chain Security Act (DSCSA) Implementation Plan

FDA Posts 3 New Draft Guidances RE: Human Drug Compounding

• FDA cGMP QSR GMP Online Training - by SkillsPlus International Inc.
  
• Purchase a California Designated Representative training course for:  
       Wholesalers | 3PL | Reverse Distributors

Updated June 18, 2025

All the links broke in the original post.

You'll be interested in:

• Human Drug Compounding - FDA.gov
• Compounding Research - FDA.gov
• Compounding Quality Center of Excellence On-demand Training - FDA.gov

- - -  original post follows below  - - -

The FDA just published 3 new draft guidances related to compounding. 


In a nutshell, they cover: earlier guidance prohibitions; "outsourcing facilities" (OF) voluntary registration; and how OF's should report their compounded drugs.

Category	Title	Type	Date
Procedural	Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 107KB)	Draft Guidance	12/02/13
Procedural	Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 60KB)	Draft Guidance	12/02/13
Procedural	Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act (PDF - 91KB)	Draft Guidance	12/02/13

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- - -

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

CA e-Pedigree - Nice Analysis

Image via Wikipedia

Updated May 26, 2022:

• Board-approved California Designated Representative online training programs for wholesalers, 3PLs, and reverse distributors.

California Board of Pharmacy Re-awaken:  'via Blog this'

If you're following the evolution of California e-Pedigree, then you'll want to read this analysis by Dirk Rodgers.

The key takeaway for me is, Board of Pharmacy guidance is needed before folks can plan and act:

". . . the Board needs to provide some guidance on, but there are some other very important questions that need to be answered before companies are likely to fully invest in pedigree solutions.  Here I’m referring to both solution providers and companies within the supply chain."

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- - -

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

News On FDA Home Use Device Initiative

• Recommended FDA GMP online training courses sold by SkillsPlus International Inc.
• California HMDR Exemptee license training certification course for home medical device retailers - Learn more - Buy now!

Updated March 8, 2026

Links broke in the original post.

You can still read about the topic here:
FDA Home Use Devices Initiative Webpage

- - - original post below - - -

The FDAnews reports, "The FDA may suggest devicemakers create different written instructions for the patient, prescriber of the device and the person training the consumer on how to use the device, Mary Weick-Brady, a senior policy analyst at CDRH, said."

New sets of instructions for patient, prescriber, and trainer will have ramifications for home care providers.

Learn more about the FDA Home Use Device Initiative:

• FDA to Address Challenges of Using Complex Medical Devices in the Home
• FDA Medical Device Home Use Initiative (pdf)

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