e-Pedigree Updates - CA Rx Board - Enforcement Comm Mtg 3/14/13

• If you need a California Designated Representative - Wholesaler, or a California Designated Representative - 3PL, they'll need Board-approved training to apply for their Designated Representative license application. Board-approved California Designated Representative courses: - Wholesaler Training Course - 3PL Training Course - Reverse Distributor Training Course    ---  NEARLY 10,000 STUDENTS HAVE TAKEN OUR STATE LICENSE-RELATED TRAINING COURSES  ---
  

Updated December 5, 2025

The meeting minutes link in the original post has been updated.

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More e-Pedigree conversations, taking place at CA Board of Pharmacy meetings.

[The video link has been removed]

Here's a video from the Enforcement Committee Meeting of March 14, 2013 that covers the following agenda items (Tip: e-Pedigree discussion starts at the 2 hr & 9 min mark):

Discussion on the Implementation of California’s Electronic Pedigree - Requirements for Prescription Medication

• A. Update on the Status of Proposed Regulations to Implement Serialized Numeric Identifiers, Grandfathering and Manufacturer Reporting of How the 50 Percent Threshold of Serialized Products on January 1, 2015 Has Been Determined (Proposals to Add Title 16, California Code of Regulations, Sections 1747 and 1747.1)
• B. Presentations and Questions from the Pharmaceutical Supply Chain on Their Readiness to Meet California’s Staggered E-Pedigree Implementation Schedule
• C. Discussion Concerning Elements for Possible Regulation Requirements to Permit Inference as Provided by California Business and Professions Code Section 4163
• D. Discussion on the Certification Process to Comply with California’s E-Pedigree Law
• E. Discussion on the Use of Drop Shipments in an E-Pedigree System
• F. General Discussion/Questions and Answers

Additional information:
Meeting minutes

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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

FDA Summary - 2013 Compounding Pharmacy Inspections

• California Board of Pharmacy Designated Representative Training Courses by SkillsPlus International Inc.  |  Board Approved  |  for wholesalers, 3PL, reverse distributors.  If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit (accepted by the Board) by taking any one of our courses.

Updated Aug 28, 2020:

You might also be interested in this FDA webpage:  Human Drug Compounding - FDA.gov

or

this recent headline story:  Cardinal Health sued over alleged fraudulently obtained contracts - SeekingAlpha.com

- - -   original post follows below   - - -

Pharmacy Compounding > Summary: 2013 FDA Pharmacy Inspection Assignment:

"The agency is currently evaluating the information obtained during the inspections and where applicable, will apply its existing legal authority to protect the public health. For the firms that are operating outside the bounds of traditional pharmacy compounding and who had significant sterile production issues, FDA plans to take aggressive action, including through enforcement actions, as appropriate."

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• California Board of Pharmacy Designated Representative Training Courses by SkillsPlus International Inc.  |  Board Approved  |  for wholesalers, 3PL, reverse distributors.  If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit (accepted by the Board) by taking any one of our courses.

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

Round 2 Contract Suppliers Listed

• California HMDR Exemptee Training Certification Course - for home medical device retailers.

CMS Announces Round Two Contractors -- HME Business:

"Finding Contract Holders

To find Round Two contract holder, the Competitive Bidding Implementation Contractor, Palmetto GBA, has released a PDF listing all the contract holders at [. . .]

Also, CMS’s online searchable supplier directory is already showing which providers are holding competitive bidding contracts. To find the contract-holders for specific categories in specific areas, visit [. . .]  and enter the zip code in question; select up to five product categories; and then scroll down and click the green “search” button."

Resources:
Medicare.gov - Supplier Directory - Find a Supplier by Zip Code

Return Home:  The Designated Representative and Exemptee Blog

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California HMDR Exemptee Training Certification Course - for home medical device retailers.

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 Pedigree Law Exemptions

Purchase now to enroll in a California Designated Representative Training Course for:

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

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Are Your Drugs Exempt From The California Pedigree Law?:

"Not all prescription drugs will need to comply with the California pedigree law on January 1, 2015 or 2016. In fact, there are a number of important exemptions that cover entire classes of certain drugs and certain types of transactions for all drugs. The volume of drug packages that could escape being serialized and pedigreed by those effective dates is not huge, but if you are a manufacturer or wholesaler, you should familiarize yourself with the list of exemptions. If you are lucky enough to make or handle any of the exempt drugs or transactions you might as well take advantage of your exemption." . . .   . . .

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

FDA Considers Compounding Industry User Fees

Hamburg: User Fees Might be Solution for Funding Increasing Regulation of Compounding Industry:

Hamburg said in her blog posting that FDA "looks forward to working with Congress to explore funding mechanisms, which could include registration or other fees, as Congress has authorized and FDA has successfully implemented in other settings."

Such funding might be able to bridge the gap between agency goals and resource limitations. Left unclear, however, is whether the pharmaceutical compounding industry would be on board with the proposal. Past user fee proposals, such as the Prescription Drug User Fee Act, the Medical Device User Fee Act and the Generic Drug User Fee Act have all been passed with the explicit support of their respective industries.

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CA Designated Representative online web-based training certification by SkillsPlus Intl Inc.
FL Designated Representative online e-Learning exam preparation by SkillsPlus Intl Inc.
The Designated Representative Institute

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

SkillsPlus Intl Info Blog

Hamburg Says FDA Needs New Authorities to Regulate Pharmacy Compounding

• FDA CGMP online training courses offered by SkillsPlus International Inc.
• California Designated Representative training courses for:
        Wholesalers | 3PL | Reverse Distributors

Updated April 19, 2022

The original post didn't age well.

You can read more here:

• Compounding and the FDA: Questions and Answers - FDA.gov
• Compounding Quality Center of Excellence On-demand Training - FDA.gov

---  the original post follows below  ---

FDA Must Have New Authorities to Regulate Pharmacy Compounding | FDA Voice:

"In the new framework, FDA believes that certain high-risk sterile compounding facilities should be subject to federal oversight to ensure that the compounding of sterile drug products at those facilities can be done without putting patients at undue risk, including . . .

And for all pharmacy compounding, FDA believes certain basic protections should be in place. These include . . ."

'via Blog this'

New Framework:

• Require compliance with federal quality standards, appropriate for the compounding of riskier products & exposure of larger numbers of patients,
• Require federal registration of the compounding facilities that will be subject to federal quality standards so FDA knows where they are and what drug products they are making.
• Require those higher-risk compounding pharmacies to report to FDA serious adverse reactions to their drugs of which they become aware.

Basic Protections:

• Grant clear authority to examine a pharmacy’s records to more quickly locate the cause of an outbreak or other violations of the law.
• Prohibit compounding of the most complex and highest risk products—drugs and biologics that should only be made for patients by an FDA-registered drug manufacturer under an approved new drug application. 

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

Rotech Files Bankruptcy

• California HMDR Exemptee license training certification course for home medical device retail Exemptee license applicants. Offered by SkillsPlus International Inc. | State-approved by the California Department of Public Health - Food and Drug Branch.

Rotech to file for bankruptcy | HME News:

"“After careful planning and consideration, we are pleased to have reached this major milestone of substantially reducing our debt,” stated President and CEO Steven Alsene in a release. “The company has struggled for years under the debt burden placed on it when it was spin off from its former parent company in 2002. Since that time, dramatic reimbursement reductions have made it essential that we reduce our debt to a manageable level.”"

'via Blog this'

You might also be interested in:  Rotech Healthcare - About Us

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