Showing posts with label laws. Show all posts
Showing posts with label laws. Show all posts

Tuesday, January 4, 2022

LAWBOOK FOR PHARMACY - California State Board of Pharmacy

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. Board-approved.

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Keywords & Phrases:
#CaliforniaDesRep #CaliforniaDesignatedRepresentative
Best | Top | Recommended | Popular | Respected | choice place for training


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, September 30, 2021

California Designated Representative - Disciplinary Actions

Updated June 15, 2026

California State Board of Pharmacy - Disciplinary Actions

If you:

  • are a California Designated Representative applicant or licensee, or 
  • manage a wholesale or 3PL facility, 

- then your professional status and public reputation rest upon legal and regulatory compliance.

When facilities and/or licensees break applicable laws and regulations, the Board takes enforcement action. Typically, the Board files accusations, and then follows that with disciplinary action.

When disciplinary action occurs, people (including the public and consumers) can learn about it through a couple of ways:

  • They can view lists of licensees reported on the Board's Disciplinary Actions webpage, or
  • They can read the details of each case, naming the licensee, the cause for discipline, and the resulting Board action, as reported in the Board's newsletter, The Script. In each issue of The Script, in a section labeled "Disciplinary Actions," individual cases are hyperlinked and can open up a detailed legal document for the case.

Resources:


Register now! Enroll now to take a Board-approved California Designated Representative online training course for:  Wholesalers | 3PL | Reverse Distributors. Image of the Golden Gate Bridge.
Register now! Enroll now to take a Board-approved California Designated Representative online training course 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):

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:  

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, March 6, 2020

Florida Certified Designated Representative (CDR) Exam - Test Preparation

Florida Certified Designated Representative (CDR) Exam - Test Preparation

If you're interested in Florida CDR exam prep, then there's a good chance you'll also be interested in:


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):

Saturday, November 23, 2019

Florida CDR - Printable Law Book

Updated August 3, 2026

Florida Certified Designated Representative Law Book  (Drugs, Devices and Cosmetics – Certified Designated Representative – Printable Law Book)

Here's a nice resource for Florida CDRs who are already licensed or are preparing to take the CDR Laws & Rules Examination.

Navigate to the webpage that has the printable law book link, "Drugs, Devices and Cosmetics – Certified Designated Representative – Printable Law Book (F.S. 499, F.A.C. 61N-1, Code of Federal Regulations, Title 21 & United States Code, Title 21)."


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Florida CDR Examination Prep Course for Certified Designated Representative license applicants
Florida CDR Examination Prep Course for Certified Designated Representative license applicants


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, July 23, 2019

Our STAT Op-Ed: Drug Importation Can’t Coexist with U.S. Track-and-Trace Law - DrugChannels.net

Read the full text of the Op-Ed:  Our STAT Op-Ed: Drug Importation Can’t Coexist with U.S. Track-and-Trace Law - DrugChannels.net

From the Op-Ed:
"As we see it, there is no legal or operational way of transforming a drug packaged for a foreign market into a drug that meets the U.S. requirements of our in-progress track-and-trace system. What’s more, there is no way to alter the law to enable importation without undermining the law’s purpose and value.  ... 
Importation laws undermine the country’s progress in building a modern technology infrastructure to track and trace prescription drugs. Making exceptions to the in-progress track-and-trace system would ignore the many instances of drug diversion and counterfeiting that led to the creation and passage of the law in 2013."

The Op-Ed covers the following areas:
  • State drug importation laws undermine the process that keeps our supply chain safe
  • Why the U.S. is building a track-and-trace system 
  • How track-and-trace works 
  • Importation undermines the track-and-trace system
  • Importation enables counterfeits 
  • Forgetting the lessons 
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California Designated Representative Training Courses (for wholesaler, 3PL, reverse distributor). Largest selection of Board-approved California Designated Representative online training courses. Earns a training affidavit accepted by the California State Board of Pharmacy.
California Designated Representative Training Courses (for wholesaler, 3PL, reverse distributor). Largest selection of Board-approved California Designated Representative online training courses. Earns a training affidavit accepted by the California State Board of Pharmacy.

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):

Monday, January 29, 2018

California HMDR Laws for 2018

California HMDR Laws for 2018

New CA Home Medical Device Retailer (HMDR) Law - Effective Jan 1, 2018

Read the full Bill:   Bill Text - AB-1387 Home medical device retail facility business: licensing: inspections.:

"AB 1387, Arambula. Home medical device retail facility business: licensing: inspections.

The Sherman Food, Drug, and Cosmetic Law, among other things, prohibits a person from conducting a home medical device retail facility business in the state without a valid license from the State Department of Public Health. Existing law requires the department to inspect each place of business prior to issuing a license, and further requires the department to inspect each licensee at least annually.

This bill would modify, until January 1, 2023, the requirement for the department to inspect a licensed home medical device retail facility business if it is accredited, as specified, by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services. If so accredited, the bill would authorize the department to conduct an inspection only upon a complaint made to the department regarding the licensee. For a licensee that is not so accredited, the bill would continue to require the department to conduct an inspection at least annually."

'via Blog this'

Source: The legislation above is referenced on the CA HMDR Program website

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Training program and certification for California Home Medical Device Retailers (HMDR) Exemptee license applicants - Earn a completion certificate


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

     California (earn a training affidavit):

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

     California (earn a training completion certificate):

Monday, November 21, 2016

California Pharmacy Law Changes


Updated for 2026:

It's that time of year again.   The CA Board of Pharmacy has published its compilation of law changes that take effect this current year.

Statutory Changes to Pharmacy Law - Changes effective for the current year - Published by the CA Board of Pharmacy (PDF)

California Designated Representative Training Courses - Accepted by the California Board of Pharmacy - Earn a training affidavit to include in your license application

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, April 21, 2016

Florida’s Adoption of Federal Exemptions for Wholesale Drug Distribution May Benefit Pharmacies, Practitioners and Hospitals | Akerman LLP - Health Law Rx - JDSupra

Read the full article: Florida’s Adoption of Federal Exemptions for Wholesale Drug Distribution May Benefit Pharmacies, Practitioners and Hospitals | Akerman LLP - Health Law Rx - JDSupra:

"The 2016 Florida Legislature enacted substantial legislation (Ch. 2016-212, Laws of Florida) to bring Florida’s Drug and Cosmetic Act (Ch. 499, Florida Statutes) in line with the federal Drug Supply Chain and Security Act (“DSCSA”). Since the DSCSA preempts state law, the changes were necessary to avoid confusion between the state and federal exemptions to the term “wholesale distribution”."

'via Blog this'

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

     California (earn a training affidavit):

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

     California (earn a training completion certificate):

Friday, November 13, 2015

California Designated Representatives - Learn from these enforcement actions


Learn from these enforcement actions taken against wholesalers and California designated representatives, going back to 2007.

Go to:  The California Board of Pharmacy |  Enforcement Actions | Accusations Filed

Approach the "accusations filed" as case studies, and situations to learn from and avoid. These are real life examples of what can happen when applicable laws, rules, and regulations are not understood or followed.

There are a lot of cases, and there's quite a diverse mix of cases that are listed, including those involving wholesalers and designated representatives.  You'll want to sift through, and look for the cases that indicate:
  •  Site license: Wholesale Permit No. WLS #
  •  Personal license: Designated Representative License No. EXC #
The cases contain a lot of information, and I suggest starting out simply, by scanning these sections: case review of applicable rules and regulations; and the associated causes for discipline.

You might also be interested in:
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):

Monday, November 2, 2015

Didn't Pass The Florida Certified Designated Representative (CDR) Examination?

Updated March 15, 2026

Question:
I took the Florida Certified Designated Representative Laws and Rules Examination, and did not pass. What could happen next?

Answer:
"A candidate who fails to achieve the required passing score on the examination must wait 30 days before retaking the examination. A candidate will have 18 months, from the date they are authorized to test, to pass the examination. After 18 months the candidate must reapply to the Department. Pertinent reexamination information is provided to all affected candidates along with the original grade report"  (source: Florida CDR CIB)

'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, September 9, 2014

Controlled Substances Authorities - State Profiles - NASCSA

United States
United States (Photo credit: Wikipedia)
The National Association of State Controlled Substances Authorities (NASCSA) is an educational organization, that focuses on increasing the effectiveness and efficiency of state and national efforts to prevent and control drug diversion and abuse.

On their website, they publish a great resource, "State Profiles." On the NASCSA State Profiles webpage, when you click on a state of your interest on the map of the USA, you're presented with state-specific information, such as:
  • State controlled substances authorities & their contacts
  • State laws, statutes, regulations, and rules
  • State prescription monitoring programs (PMP) & contacts
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):

Wednesday, November 16, 2011

CA HMDR Facilities Must Have Policies and Procedures

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CA HMDR Facilities Must Have Policies and Procedures | SkillsPlus International Info:  'via Blog this'
Section 111656.3 starts out with:  
"Each home medical device retail facility shall have written policies and procedures related to home medical device handling and, if authorized by the department pursuant to Section 111656.4, the dispensing of prescription devices. Those written policies and procedures shall be adequate to assure compliance with this article and shall include, but not be limited to . . . "  
Notice the phrase, " . . . shall have written policies and procedures . . . "
You might also be interested in:
Writing Procedures: Drug and Device Wholesalers and HMDR - an online training course

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):



Monday, November 14, 2011

California Board of Pharmacy - Laws and Regulations

Updated October 16, 2023

The new laws for 2012 document is no longer available.

You might also be interested in:


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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, September 9, 2011

CA e-Pedigree - Board of Pharmacy Mtg Update - Sept 7, 2011

Updated 12/6/2011:

The minutes finally got posted. You can find them here, and they include:
Discussion on the Implementation of California’s Electronic Pedigree Requirements for Prescription Drug

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, May 31, 2011

Florida CDR - Collection of links to applicable laws and rules

  • "The Department of Business and Professional Regulation’s Candidate Information Booklet (CIB) provides additional information to prepare candidates to take their professional licensure examinations. Click this link to view and download Candidate Information Booklets.
  •  A printable law booklet is available for download that includes current versions of Chapter 499, Florida Statutes, Chapter 61N-1, Florida Administrative Code, Code of Federal Regulation, Title 21, and United States Code, Title 21. These references are available to assist candidates in preparing for the Certified Designated Representative examination. Click this link to view and download the printable law booklet."

---  original post follows below - links updated 4/11/18  ---

I'm providing you with a convenient collection of links to these laws and rules:

Chapter 499 Florida Statutes - All sections relating to prescription drugs

Rule Chapter 64F-12, Florida Administrative Code (Note: 64F-12 has been transferred over to:
Rule Chapter 61N-1 Florida Administrative Code) - All sections relating to prescription drugs

21 Code of Federal Regulations (CFR) - Part 205:
  • 205.2 
  • 205.3 
  • 205.4 
  • 205.6
  • 205.8 
  • 205.50 
21 United States Code (USC):
  • 321
  • 331
  • 333
  • 351
  • 352
  • 353

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Designated Representative Training Courses - California & Florida
Designated Representative Training Courses - California & Florida

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

     California (earn a training completion certificate):

Tuesday, March 8, 2011

California Pharmacy Law Changes

Updated January 1, 2026

Posting this just in case you might have missed this.

California pharmacy law changes were added or amended during the last legislative session. Unless otherwise indicated, all these provisions go into effect this current year.

Here's the PDF of the changes:   California Pharmacy Law – Changes effective for the current year (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):

Tuesday, January 25, 2011

California Pharmacy Laws (was 2011)

Updated January 4, 2019:

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

Not sure what's changed?  You might find some help in this document:
New California Pharmacy Laws effective this current year (PDF) - Free

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

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

     California (earn a training completion certificate):


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