Showing posts with label law. Show all posts
Showing posts with label law. Show all posts

Saturday, January 1, 2022

California Designated Representative Training Courses

In a hurry?  Enroll now in any one of our Board-approved California Designated Representative training courses to earn a training affidavit for your license application:

California Designated Representative Training Courses

Don't get caught snoozing in the new year!

Nearly 10,000 Students Have Taken Our Courses!

Here's why our online training programs are so popular and highly recommended:
  • These online training courses are designed for California Designated Representative license applicants and their managers. We make the messy regulatory requirements simple and easy to understand!
  • Earn a Board-accepted training affidavit, for your license application, by taking any one of our courses.
  • No need to schedule your training. Buy the course. Start when you’re ready! Therefore, buy now and start studying!
  • Online internet-based e-learning, easily accessed to make it possible & convenient for you to study from your home or office, in other words, study in any location!
  • Our courses involve more than just reading slides.
  • Available 365 x 24 x 7. Come and go as needed. In other words, our courses are convenient and flexible.
  • Composed of a series of self-study pre-recorded presentations that cover essential and required topics (as specified on their respective California Designated Representative license application form).
  • Designed with a follow-up quiz after each course section. When you finish, you will request your completion documents, specifically, your training affidavit.
  • We’ve added something new, closed captioning. Students can read what the course instructor is teaching. This feature helps ESL (English as a second language) students, and hard of hearing students. Therefore, our courses are more accessible.
  • Offered continuously since 2002. Therefore, we have a long record of experience.
Updated For 2022 Law Changes | California Designated Representative Training Courses. Image of medication pill capsules on a rose colored background.
California Designated Representative Training Courses.

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Keywords & Phrases:  wholesaler, 3PL, third-party logistics provider, reverse distributor, Board of Pharmacy, 2027, 2025, 2026, pharmacy law, rules and regulations

Monday, January 11, 2021

LAWBOOK FOR PHARMACY - California State Board of Pharmacy

Updated January 1, 2026

It's that time of year again.

Here's the updated California Pharmacy Law Book for the current year.

Lawbook for Pharmacy - a free publication from the California State Board of Pharmacy (PDF)

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California Designated Representative Online Training Courses. For: 3PL, wholesalers, reverse distributors. Designated Representative Training | Exemptee Training. California Designated Representative online training courses. Florida CDR training and examination preparation. California HMDR Exemptee online training certification.
California Designated Representative Online Training Courses. For: 3PL, wholesalers, reverse distributors. Designated Representative Training | Exemptee Training. California Designated Representative online training courses. Florida CDR training and examination preparation. California HMDR Exemptee online training certification.  


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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Wednesday, January 6, 2021

California - Statutory Changes in Pharmacy Law

Updated January 2, 2026

The PDF for 2021 is no longer available.

You can download the pharmacy law changes for the current year from this Board webpage:
---  the original post follows below  ---

Statutory Changes in Pharmacy Law - Published by the California State Board of Pharmacy

Unless otherwise noted, the provisions take effect January 1, 2021

View the 31 page source document, "Pharmacy Law Changes for 2021 (PDF)," on this Board webpage:  

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Sunday, January 26, 2020

California Pharmacy Law Book for the New Year

Updated January 1, 2026

It's here!

For the current year:  Lawbook for Pharmacy (California)

According to the Board, "The lawbook contains pharmacy-related excerpts and sections from the Business and Professions Code, California Code of Regulations, Health and Safety Code, Civil Code, and other statutory codes. The document is published in Adobe PDF and is searchable by keyword."

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The largest collection of Board-approved California Designated Representative online training programs for wholesalers, 3PL, reverse distributors.
The largest collection of Board-approved California Designated Representative online training programs for wholesalers, 3PL, reverse distributors.

Return Home:  The Designated Representative and Exemptee Blog

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Friday, January 4, 2019

New! This year's edition of the California Pharmacy Law Book with Rules and Regulations

It's free, and it's online:

California Pharmacy Law Book with Rules and Regulations for the current year (PDF)

Return Home:  The Designated Representative and Exemptee Blog

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

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

Tuesday, January 2, 2018

California Pharmacy Law Book

Updated May 21, 2026

Lawbook For Pharmacy - California

California Pharmacy Law Book with Rules and Regulations for the current year

Statutory Changes to California Pharmacy Law - Effective this current year

It's that time of year again.  The new California Pharmacy Law Book is now available.

Notable for our audience in 2018, is the creation of the California Designated Representative Reverse Distributor license.

Follow the two links above, to read the laws.

Return Home:  The Designated Representative and Exemptee Blog

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Return Home:  The Designated Representative and Exemptee Blog

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Wednesday, August 30, 2017

How Many California Designated Reps Do I Need?

Several California Designated Representatives Might Be Needed - Consider These Reasons

California Pharmacy Law

According to the California Board of Pharmacy website:

"Wholesale operations that distribute dangerous drugs or dangerous devices must be supervised by a registered pharmacist or an individual approved by the board as a designated representative. These companies may not operate unless the pharmacist or designated representative is physically on the licensed premises. To ensure proper control at all times, the board recommends that there be more than one person approved to supervise operations." Specifically, the California Wholesaler license application says (in boldface), "There must be one designated representative on the premises at all times during business operation."

"Each place of business of a third-party logistics provider shall be supervised and managed by a responsible manager. The responsible manager shall be responsible for the compliance of the place of business with state and federal laws governing third-party logistics providers and with the third-party logistics provider's customer specifications, except where the customer's specifications conflict with state or federal laws. The responsible manager shall maintain an active license as a designated representative-3PL with the board at all times during which he or she is designated as the responsible manager." Specifically, the California Third-Party Logistics Provider license application says (in boldface), "There must be one licensed designated representative-3PL on the premises at all times during business operation."
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When the business operations and staffing model are taken into consideration, some companies will need more than one designated representative. In other words, when the business is operating, there must be at least one designated representative there. Scheduling designated representative coverage starts to get tricky when you figure in vacations, days off, multiple shifts, etc. To reiterate the Board, there must be one licensed designated representative on the premises at all times during business operation.

Good Business Practice

And just when you think you've got it all covered ...

It's not unusual for some businesses to manage with just one designated representative, or keep the bare minimum of licensed designated representatives on staff.  However, these companies can run into a situation that can affect the company's business financial health. In the event the company loses a licensed designated representative, for example, the designated rep quits, and cross-coverage by another licensed designated representative isn't possible, then the business operation could get into trouble with the Board, or just as bad, must shut down (until a licensed designated rep can be on premise).

It's a difficult scenario, to be left scrambling, trying to find, hire, and get a new employee properly licensed as a designated rep.  Therefore, consider the risks, and keep just the "right" number of licensed designated representatives.

Return Home:  The Designated Representative and Exemptee Blog

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

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Friday, July 14, 2017

6 Misconceptions About Fraud | HomeCare Magazine

Misconceptions About Fraud

Read the full article: 6 Misconceptions About Fraud | HomeCare Magazine:

"There is a danger of complacency if you ignore these six common misconceptions about fraud and abuse in the HME industry. If you are alert, you should be better prepared to both create and enforce your company’s compliance policies, and avoid a fraud investigation."

'via Blog this'

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Training program for California HMDR Exemptee license applicants
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

Wednesday, June 10, 2015

Track and trace: Is your pharmacy in compliance with the new law? | American Pharmacists Association

Updated August 18, 2021

The original link broke.

You can still read about the same topic here:

---  the original post follows below  ---

Read the full article: Track and trace: Is your pharmacy in compliance with the new law? | American Pharmacists Association:

"Is your pharmacy ready for the new track-and-trace law? Under the Drug Supply Chain Security Act, January 1 and July 1 are the key dates in 2015 for new requirements for pharmacies.

Per the new law, as of January 1, 2015, pharmacies shall only accept drug products from authorized trading partners. Also, pharmacies are required to have processes in place to identify, quarantine, and investigate suspect products and determine whether products are illegitimate. By July 1, 2015, pharmacies must be able to capture and maintain transaction information (TI), transaction history (TH), and a transaction statement (TS)—sometimes referred to as “the three Ts”—for each drug product received for 6 years from the date of the transaction."

'via Blog this'

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Tuesday, September 30, 2014

Will The FDA Delay The DSCSA? - Rx Trace

Read the full article:  Will The FDA Delay The DSCSA? - Rx Trace:

"More and more people are asking if the FDA will delay the January 1, 2015 requirements of the Drug Supply Chain Security Act (DSCSA).  On that day, drug manufacturers, repackagers and wholesale distributors must begin exchanging Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS), (dispensers join them next July) and the FDA is not even due to publish guidance on how to do that until November 27" . . .

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):


Friday, June 6, 2014

Changes in California Pharmacy Law

Updated January 5, 2019:

California Pharmacy Law changes effective this current year (PDF)

---  the original post follows below  ---

You might be interested in the following article, published in the latest edition of the California Board of Pharmacy Newsletter, The Script (Spring 2014) - PDF

The article is titled, "Changes in Pharmacy Law for 2014."  The organization and formatting make the article a very easy and useful read. Here's a snippet from the article:

"The Senate and Assembly bills listed in this article were enacted in 2013 and unless otherwise specified took effect on January 1, 2014. The new and amended Business and Professions Code (B&PC), Health and Safety Code (H&SC), and Civil Code laws are paraphrased or summarized below. For pertinent information that is not included in the summaries you are strongly urged to review the exact language at http://www.pharmacy.ca.gov/laws_regs/new_laws.pdf  "


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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Wednesday, May 21, 2014

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

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

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Tuesday, February 11, 2014

California's E-Pedigree Law Preempted

Updated September 24, 2020

The link in the original post broke.

Here's the full text article from the California State Board of Pharmacy.  Source:  The Script (Spring 2014, page 4) - California State Board of Pharmacy: E-pedigree Pre-empted by National Tracking System Law .

"On November 27, 2013, President Obama signed Public Law
113-54, which contains provisions for a national tracking system
for prescription medication.

Included within this law are provisions that pre-empt
California’s e-pedigree requirements that were enacted originally
in 2004 and were to be in full effect by July 2017. California’s
Business and Professions Code contains provisions that
effectively preempt California’s provisions if federal legislation
in this area is enacted.

The board is required to post a message about the
inactivation of California’s e-pedigree provisions. This notice
is provided below; it also will be published in the California
Regulatory Notice Register and posted on our website. Also, this
year the board will sponsor legislation to repeal the e-pedigree
provisions that are now inactive provisions in California law.

The board thanks the many individuals including
pharmaceutical supply chain companies, computer and
technology firms, policy makers, staff of the California
delegation and the many others who worked with the board over
the last 10 years to develop e-pedigree provisions and implement
a system to strengthen the integrity of the US drug supply.

We especially thank the early adopters and those who
worked on pilot projects to ensure California’s provisions
would be implemented by the coming deadlines. It was a large
endeavor and we trust that what was learned to “get ready for
California” will be transferable to the national system that is now
under development. We are grateful to have played a role in this
important area of public safety and health.

Public Notice:

Pursuant to Business and Professions Code section 4034.1,
which provides in pertinent part that “[u]pon the effective date
of federal legislation . . . addressing pedigree or serialization
measures for dangerous drugs, Sections 4034, 4163(c)
– (g), 4163.1, 4163.2, 4163.4, and 4163.5 shall become
inoperative,” and which requires that within 90 days of the
enactment of such legislation the board publish a notice regarding
the invalidation of these statutes, the California State Board of
Pharmacy is hereby publishing notice that federal legislation
meeting the requirements of section 4034.1 has been enacted, and
that Business and Professions Code sections 4034, 4163, 4163.1,
4163.2, 4163.4, and 4163.5 became inoperative as of November
27, 2013."

- - -  original post follows below  - - -

California Board of Pharmacy - Information on E-Pedigree:

"Public Notice:

Pursuant to Business and Professions Code section 4034.1, which provides in pertinent part that “[u]pon the effective date of federal legislation . . . addressing pedigree or serialization measures for dangerous drugs, Sections 4034, 4163(c) – (g), 4163.1, 4163.2, 4163.4, and 4163.5 shall become inoperative,” and which requires that within 90 days of the enactment of such legislation the board publish a notice regarding the invalidation of these statutes, the California State Board of Pharmacy is hereby publishing notice that federal legislation meeting the requirements of section 4034.1 has been enacted, and that Business and Professions Code sections 4034, 4163, 4163.1, 4163.2, 4163.4, and 4163.5 became inoperative as of November 27, 2013."

'via Blog this'

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Drug Wholesalers & 3PL.  If you're applying for a California Designated Representative license, you must include a training affidavit (proof of required training) in the application. Take these California Designated Representative training courses & get a training affidavit.

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Thursday, January 16, 2014

What Are The FDA's CGMPs? Ramifications for Compounding Outsourcing Facilities

Updated February 4, 2026

Some of the links in the original post broke.

You might also be interested in:
---  the original post follows below  ---

On November 27, 2013, President Obama signed the Drug Quality and Security Act (DQSA), legislation that contains important provisions relating to the oversight of compounding of human drugs. In the new law, a compounder can become an “outsourcing facility.” Outsourcing facilities must comply with CGMP requirements. (Source:  FDA.gov - Compounding Quality Act - Title I of the Drug Quality and Security Act of 2013)

The FDA (Food and Drug Administration) puts forth the cGMP regulations (current good manufacturing practice). The CGMPs are also commonly referred to as:
  • GMP - good manufacturing practice, or
  • CGMPR (current good manufacturing practices regulations)
If you're unfamiliar with the FDA cGMPs, then consider taking this online course:
21 CFR 211: Pure, Safe, and Effective - an introduction to the FDA cGMPs

Return Home:  The Designated Representative and Exemptee Blog

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Tuesday, January 14, 2014

California Pharmacy Law Changes

Updated January 5, 2019:

California Board of Pharmacy - California Laws Changes effective this current year (PDF)


Return Home:  The Designated Representative and Exemptee Blog

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Thursday, November 28, 2013

Obama signs Drug Quality and Security Act into law - SecuringIndustry.com


SecuringIndustry.com - Obama signs Drug Quality and Security Act into law:

"President Obama has signed H.R. 3204 into law, setting the wheels in motion for the FDA to develop a national track-and-trace system to secure the pharmaceutical supply chain.

The aim of the Drug Quality and Security Act (DQSA) is to "minimise opportunities for contamination, adulteration, diversion, or counterfeiting," whilst also clarifying the FDA's authority to regulate compounding pharmacies, according to the White House."

Return Home:  The Designated Representative and Exemptee Blog

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





Monday, November 18, 2013

Breaking news: US Senate clears track-and-trace bill - SecuringIndustry.com

SecuringIndustry.com - Breaking news: US Senate clears track-and-trace bill:

"The US Senate passed H.R. 3204 by unanimous voice vote today, bringing a national track-and-trace system for medicines and new laws governing compounding pharmacies to the brink of fruition.

With the House having given its blessing to H.R. 3204- also known as the Drug Quality and Security Act (DQSA) - at the end of September, all that remains now is for the bill to be passed to President Obama for signature."

Return Home:  The Designated Representative and Exemptee Blog

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





HDMA’s 2013 Track-and-Trace Conference: Right Here Waiting for H.R. 3204 - FDA Law Blog

FDA Law Blog: HDMA’s 2013 Track-and-Trace Conference: Right Here Waiting for H.R. 3204:

"With fingers crossed, attendees looked ahead to the future of track-and-trace. Panelists expressed that the national system will hopefully make it harder for bad actors to corrupt the integrity of the supply chain, as the current patchwork of state pedigree laws allows bad actors to shop around for more lenient states. It is hoped that this bill will put everyone on a level playing field and reduce loopholes."

Return Home:  The Designated Representative and Exemptee Blog

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

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


Updated November 24, 2025

The original post didn't age well.

You might also be interested in:

---  the original post follows below  ---

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."

Return Home:  The Designated Representative and Exemptee Blog

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

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