FDA and States Meet On Regulation of Drug Compounders

F.D.A. and States Meet About Regulation of Drug Compounders - NYTimes.com:

"Pharmacies fall primarily under state law, and the F.D.A. convened the meeting to get specifics from states on gaps in the regulatory net and how the states see the federal role. Some states said they would prefer to see the F.D.A. handle large-scale compounders like the New England Compounding Center, or N.E.C.C., the Massachusetts pharmacy that was the source of the outbreak.

“The consensus in our group was that there is a role for the F.D.A. to be involved in facilities like N.E.C.C.,” said Cody Wiberg, the executive director of the Minnesota Board of Pharmacy. “If you’re talking about compounding, most states have the authority and resources to handle that. If you’re talking about nontraditional compounding,” he said, referring to large-scale enterprises like N.E.C.C., “fewer states may have the resources to do that.”"

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

CA Designated Representative online training certification - for Drug Wholesalers
FL Designated Representative online exam preparation - for Drug Wholesalers

CA HMDR Exemptee online web-based training certification by SkillsPlus Intl Inc.
SkillsPlus Intl Info Blog

Related articles

• CA HMDR Exemptee Training - The Best Course Around

CA Board of Pharmacy - Use Of GS1 EPCIS - Pedigree

Follow the link below, to Dirk Rodgers post on the December 4th Board meeting, that touches on some important points surrounding CA pedigree law. . .

California Board of Pharmacy Clarifies Use Of GS1 EPCIS:

". . . transcribed the exchange below as it happened because I think it provides a number of important clarifications about the technologies that can successfully be used to meet the California pedigree law and I think it should be read by everyone who has an interest in that."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

CA Designated Representative online training certification - For Drug Wholesalers

FL Designated Representative online internet-based exam preparation by SkillsPlus Intl Inc.

CA HMDR Exemptee online web-based training certification by SkillsPlus Intl Inc.
SkillsPlus Intl Info Blog

Related articles

• CA HMDR Exemptee Training - The Best Course Around (skillsplusinfo.blogspot.com)
• What Is A Pharmacy Designated Representative? (skillsplusinfo.blogspot.com)

FDA on Making Medical Devices Safer at Home

Follow the link below for additional free consumer information and resources:

Consumer Updates > Making Medical Devices Safer at Home:

""(Home use) devices once were designed only to keep you alive. Now they're designed to keep you as independent as possible," according to Mary Brady, MSN, RN, a senior policy analyst at FDA's Center for Devices and Radiological Health (CDRH).

However, the Food and Drug Administration (FDA) has long been concerned that consumers may sometimes be literally left to their own devices—depending upon medical devices they might not know how to operate and for which they might not understand the safety risks.

There have been serious, and even fatal, problems reported to FDA associated with medical devices used at home. For example, a woman with kidney failure got cat hair in her dialysis tubing, resulting in peritonitis, a life-threatening abdominal infection. And a child died when his mother didn't hear an alarm on his ventilator signaling that the tubing had become disconnected."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

CA HMDR Exemptee online training certification - for HME Retailers DME Wholesalers

CA Designated Representative online internet-based training certification by SkillsPlus Intl Inc.
FL Designated Representative online web-based exam preparation by SkillsPlus Intl Inc.
SkillsPlus Intl Info Blog

Related articles

• CA HMDR Exemptee Training - The Best Course Around
• The Only Vote That Counts: FDA 483 Round-Up
• Obamacare May Hike Your Pet's Health Care Bills
• Making Medical Devices Safer at Home

How To Get California CDPH HMDR Exemptee Training Certification

You need to take the best and highly recommended California Department of Public Health (Food & Drug Branch) - Exemptee Training Certification course:

• California HMDR Exemptee Training Certification Course by SkillsPlus Intl Inc. | Learn more & buy!

The reasons are simple:

1. This training course is incredibly popular
2. This is a highly regarded program, taught by a well-respected instructor
3. This internet-based online training course can be taken at your leisure 365 x 24 x 7, anytime & anywhere you want, until you fully complete the course 

Don't overlook this high quality training offering for home medical device retailers, because it will fit your training certification needs!

Return Home:  The Designated Representative and Exemptee Blog

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

California HMDR Exemptee Training Certification Course (approved by the California Department of Public Health - Food and Drug Branch)

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

• CA HMDR Exemptee Training - The Best Course Around (skillsplusinfo.blogspot.com)
• Complete Exemptee & Designated Representative Training Before School Ends & Summer Begins (skillsplusinfo.blogspot.com)
• Consider On-Site Training - Popular GMP Classes and QSR Courses (skillsplusinfo.blogspot.com)

Safe Doses Act - Penalties for Pharma Cargo Thefts - Statement by HDMA Pres. John Gray

Follow this link to read John Gray's statement on the passing of the Safe Doses Act . . .

HDMA - Press Releases - 10/09/12:

"President Obama signed into law the Strengthening and Focusing Enforcement to Deter Organization Stealing and Enhance Safety Act of 2011 (SAFE DOSES Act, H.R. 4223/S. 1002). The legislation is sponsored by Congressman Sensenbrenner (R-Wis.) in the House, as well as Senators Schumer (D-N.Y.) and Kyl (R-Ariz.)"

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

CA Designated Representative online training certification - for drug wholesalers
FL Designated Representative online exam preparation - for drug wholesalers

CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
SkillsPlus Intl Info Blog

Related articles

• CA HMDR Exemptee Training - The Best Course Around (skillsplusinfo.blogspot.com)

Public Citizen to FDA - RE: Compounding Pharmacies

Updated June 6, 2024

Links in the original post broke.

You might also be interested in:

Compounding and the FDA: Questions and Answers - FDA.gov

---  the original post follows below  ---

This is interesting reading for those of you who are following the role of the FDA in compounding pharmacy oversight.

Public Citizen to FDA: Reinspect Compounding Pharmacies Across the Country | The Legal Examiner Cleveland:

"In an 11-page letter to FDA Commissioner Margaret Hamburg, consumer watchdog group Public Citizen asked the agency to follow up on warning letters it issued to compounding pharmacies committing NECC-like violations.

Since 2003, the FDA has sent at least 18 warning letters to 16 compounding pharmacies, Public Citizen’s letter stated. In light of the 2012 fungal meningitis outbreak, the group would like the FDA to either reinspect those pharmacies or to verify that recent reinspections confirmed that those pharmacies cleaned up their act."

'via Blog this'

You might be interested in:
Public Citizen's Letter to the FDA re:  Compounding Pharmacies (PDF)

Return Home:  The Designated Representative and Exemptee Blog

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

     California (earn a training affidavit):

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

     Florida:

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

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

     California (earn a training completion certificate):

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

DEA probes Walgreens pharmacies over drug diversion in Florida

Updated August 28, 2019

The original link below broke.

You might also be interested in:
Walgreens pushed pill sales, DEA says - South Florida Sun-Sentinel

- - -  original post follows below  - - -

The Miami Field Division of the DEA issued 3 Walgreens pharmacies in FL with orders to show cause - notifications that are given to facilities requiring them to prove why they should be allowed to keep their licenses.

DEA probes Walgreens pharmacies over drug diversion in Florida - South Florida Sun-Sentinel.com:

"In April the DEA said it would inspect six Walgreens pharmacies and its Florida distribution center after the agency noticed a jump in purchases of the painkiller oxycodone. On September 14, the distribution center's registration was suspended. An administrative hearing is scheduled to begin on that matter on January 7, 2013.

The DEA has been ratcheting up its focus on drug wholesalers and pharmacies over the past year as attempts to battle what the Centers for Disease Control and Prevention calls a prescription drug abuse epidemic. Deaths from narcotic pain-killers now exceed those of heroin and cocaine combined.

Florida has long been considered the epicenter of prescription drug abuse and the DEA has dismantled dozens of "pill mills" - sham pain clinics whose doctors write prescriptions for thousands of pain pills to drug dealers and addicts."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

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

California Designated Representative Training Courses - 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 Exam 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

• Walgreen Sues U.S. to Lift Oxycodone Distribution Ban - Bloomberg (bloomberg.com)
• DEA Crackdown Makes Prescription Drugs Harder to Find (mcntalk.com)
• Combating Misuse and Abuse of Prescription Drugs: Q&A (everydayhealth.com)
• DEA Scam Alert - Don't Fall For This Extortion Scheme (browardnetonline.com)

Deaths and Injuries Associated With Bed Rails

• Enroll now! California Exemptee training course for home medical device retailers (HMDR)

Something of interest for HME and DME providers . . .

Agency Investigates Deaths and Injuries Associated With Bed Rails - NYTimes.com:

". . . death certificates and hospital emergency room visits from 2003 through May 2012 shows that 150 mostly older adults died after they became trapped in bed rails. Over nearly the same time period, 36,000 mostly older adults — about 4,000 a year — were treated in emergency rooms with bed rail injuries. Officials at the FDA and the commission said the data probably understated the problem since bed rails are not always listed as a cause of death by nursing homes and coroners, or as a cause of injury by emergency room doctors.

Experts who have studied the deaths say they are avoidable. While the F.D.A. issued safety warnings about the devices in 1995 . . ."

'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

Entrepreneur Shares His Formula in "The Next Step-Retail HME" - Book Release

• The top choice for Exemptee training! California Exemptee Training - for HMDR (home medical device retailers). $525 per student (no extra fees to retake quizzes). State approved by the California Department of Public Health. Earns a course completion certificate suitable for your Exemptee license application. #HMDR #HME #DME #HMDRexemptee
  

The book:

• is a step-by-step guide to starting up and making a retail home medical equipment business successful
  
• includes his original business plan for use as a guide
  
• provides his most recent profit and loss statement with percentages for comparison
  

Home healthcare entrepreneur Michael Kuller, RPh shares his formula for retail success in "The Next Step-Retail Home Medical Equipment":

""Using the information provided in this book, anyone can open a retail home healthcare store and make it successful. For those considering a retail home medical equipment business, this book is a must-read ", says Jack Evans, Retail Home Healthcare Expert."

'via Blog this'

Follow this link to purchase the book:
The Next Step: Retail Home Medical Equipment: Step by Step Building Your Retail Business

You might also be interested in:
California HMDR Exemptee online training certification - for HME DME retailers wholesalers
   (The CA Department of Public Health administers the Home Medical Device Retailer (HMDR) Licensing Program)

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

• CA HMDR Exemptee Training - The Best Course Around (skillsplusinfo.blogspot.com)

California HMDR Exemptee Training Requirements

• California Home Medical Device Retailer (HMDR) Exemptee Training Certification Course (accepted by the California Department of Public Health - Food and Drug Branch)

Q.  I'm submitting an application for a Home Medical Device Retailer (HMDR) Exemptee license, as a new applicant. What are the things that I need to pay attention to, regarding training requirements?

A.  According to the referenced CDPH HMDR license application form:

• New applicants must meet minimum qualifications, including proof of completing a training program (that addresses 5 topic areas).
• In order to prove training completion, the applicant must submit a copy of the completed training certificate (or transcript).
• Specifically, in the Minimum Qualifications - Training Programs section: Indicate by yes or no the training you have completed specific to the five topics listed. Attach copies of certificates or transcripts.

Be forewarned, the application states, "Unsigned or incomplete applications cannot be processed and will be returned."

Reference:
Application for Home Medical Device Retailer (HMDR) Exemptee license - New and Renewal (Form CDPH 8695 (04/18))

California HMDR Exemptee Training Certification Course (approved by the California Department of Public Health - Food and Drug Branch)

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 - New!
• The Designated Representative Institute

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 Law Blog: FDA and CA Board of Pharmacy Talk Pedigree - Annual HDMA Track and Trace Conf

FDA Law Blog: FDA and California Board of Pharmacy Talk Pedigree at Annual HDMA Track and Trace Conference:

"The Healthcare Distribution Management Association (“HDMA”) held its annual Track and Trace Technology Seminar on November 12 – 14, 2012, designed to address drug pedigree and track and trace requirements being developed in the United States and to explore how stakeholders will play a role---and what those roles may be---going forward.  Perhaps most interesting at the conference was the seemingly unanimous support from industry for the implementation of a national pedigree program in some form.  What follows below are some of the highlights of the conference speakers. . . ."

'via Blog this'

In case you're interested:
The CA Board of Pharmacy announced that its Licensing Committee Meeting meeting will be combined with its Board meeting in which regulations for e-Pedigree will be discussed. The meeting is scheduled for December 13, 2012. For a complete list of meetings please go to: http://www.pharmacy.ca.gov/about/meetings.shtml

Return Home:  The Designated Representative and Exemptee Blog

CA Designated Representative online CBT training certification by SkillsPlus Intl Inc.
FL Designated Representative online CBT exam preparation by SkillsPlus Intl Inc.

CA HMDR Exemptee online CBT training certification by SkillsPlus Intl Inc.
SkillsPlus Intl Info Blog

TrackBack URL for the referenced article:
http://www.typepad.com/services/trackback/6a00d8341d150c53ef017ee557842d970d

Florida Compounder Tied to Tainted Eye Meds - Sight Lost

Compounder Tied to Tainted Eye Meds, Lost Sight:

"Cultures for 10 patients came up positive for Streptococcus mitis or oralis, matching the strains in seven unused syringes prepared during the same time by the compounder.

An FDA investigation of the company revealed insufficient testing and monitoring of equipment, dirty lab equipment, a failure to maintain sterilization tools, and a leaking boiler near the clean room."

'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

ASHP's Sterile Compounding Checklist

Updated April 19, 2022

You might also be interested in:

• ASHP STERILE COMPOUNDING COMPETENCY LIBRARY
• Compounding Quality Center of Excellence On-demand Training - FDA.gov

= = =
Updated September 2, 2019

The link in the original post below is broken.  You might also be interested in:

• ASHP - Sterile Compounding Resource Center
• ASHP Guidelines on Outsourcing Sterile Compounding Services (2015 PDF)

= = = original post below = = =

The American Society of Health-System Pharmacists (ASHP) just published this document:
     Eight Critical Steps Related to Sterile Compounding Services - Member Action Check List

In the checklist, ASHP says:

"ASHP strongly encourages you to review this list, even if your pharmacy department does not have a contract with an external compounding facility. This is important because off-site clinics or affiliated entities within your health system may have developed independent contracts that the pharmacy department was not involved in securing."

Return Home:  The Designated Representative and Exemptee Blog

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

The largest selection of Board-approved California Designated Representative training programs. 3 distinct courses for wholesalers, 3PL, reversed distributors. Earns a Board-accepted 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

<

Pt & Disability Groups Support Bill to Begin Market Pricing System for HME in Medicare

• State-approved California HMDR Exemptee training certification course for home medical device retailers. Earns a course completion certificate to include in your Exemptee license application.

Patient and Disability Groups Support Bill to Begin Market Pricing System for Home Medical Equipment in Medicare - PR Newswire:

"More than 30 patient advocacy and consumer groups endorsed a bill in Congress that would replace Medicare's current "competitive bidding" program for durable medical equipment with a better market pricing system that preserves access to homecare. Millions of Americans use medically required durable medical equipment and services at home, including oxygen therapy, wheelchairs, and hospital beds.

The bill, H.R. 6490, was introduced in the House of Representatives by a bipartisan group of lawmakers in September and has gained strong bipartisan support from several dozen members of Congress. The bill would replace the current, controversial bidding program with a more sustainable system, says the American Association for Homecare."

'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

• CA HMDR Exemptee Training - The Best Course Around (skillsplusinfo.blogspot.com)

California HMDR Law (Home Medical Device Retailer)

• The best choice for Exemptee training! California Exemptee Training - for HMDR (home medical device retailers). $525 per student (no extra fees to retake quizzes). State approved by the California Department of Public Health. Earns a course completion certificate suitable for your Exemptee license application. #HMDR #HME #DME #HMDRexemptee
  

Updated January 26, 2022

HMDR Law and FAQ:

"The Home Medical Device Retailer (HMDR) licensing program is administered as part of the Medical Device Safety and Youth Tobacco Enforcement Section and is governed by law sections found in the California Sherman Food, Drug and Cosmetic Law.  The Sherman Law was amended in the 1999-2000 legislative session to establish the HMDR licensing program.  This section of the Sherman Law can be found by following the link below.  It is in the Adobe PDF format so you will need an Adobe reader program to open and print the document."

'via Blog this'

California HMDR Sherman Law (FDB) 

Related articles

• CA HMDR Exemptee Training - The Best Course Around (skillsplusinfo.blogspot.com)
• Consider On-Site Training - Popular GMP Classes and QSR Courses (skillsplusinfo.blogspot.com)

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

The ASHP Compounding Resource Center

ASHP (The American Society of Health-System Pharmacists) has created a webpage full of compounding information. It includes current news, reference books, publications, and resources.

Compounding Resource Center:

"Welcome to the ASHP Compounding Resource Center, the first stop for ASHP information and resources on compounding standards and practices."

'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

CA Board of Pharmacy - Track your license expiration date & renew on time

• The largest selection of Board-approved California Designated Representative training programs. 3 distinct courses for:  Wholesalers | 3PL | Reverse Distributors

Updated March 16, 2021

The Board changed some of the information.

View the current webpage: 
Personal License Information/Renewal - California State Board of Pharmacy

- - -  original post follows below  - - -

Track your license expiration date, so that you can renew on time. This is important, just in case you don't get the automatically generated renewal notice.

Don't get caught scrambling!  Make sure you start the renewal process no later than 4 weeks before your license expires.

CA Board of Pharmacy:

"I did not receive my renewal notice and my license is coming up for renewal. What do I do? 

Approximately six weeks before the expiration date of your license, a renewal application will be mailed to your last known address of record. Licensees are responsible for renewing their licenses even if they do not receive a renewal notice. The board does not send duplicate renewal applications.   

If you have not received the renewal notice within 4 weeks of expiration of the license, you may renew your license by submitting a Request for Renewal form. Do not submit a renewal request more than 60 days before the expiration date of the license. 

A renewal request form may be viewed and printed by clicking on the appropriate license type below: . . . "

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

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

The largest selection of Board-approved California Designated Representative training programs. 3 distinct courses for wholesalers, 3PL, reverse distributors. Earns a training affidavit. Nearly 10,000 students have taken our state license-related online training classes.

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

Will The CA e-Pedigree Dates Slip Again?

Updated 12/9/2022

Sorry, the original link is outdated/broken.

---  the original post follows below  ---

Another good read from Dirk Rodgers . . .

Will The California ePedigree Dates Slip Again?:

". . . AND MY PREDICTION IS…

I predict that it will NOT get delayed again.  Here’s how I arrive at that prediction.

Things are different now than any time prior to any of the earlier delays. . . ."

'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

Fungal Meningitis Outbreak - State Pharmacy Chief Fired

• Trusted California Designated Representative online training courses. Enroll now in a Board-approved course for: Wholesalers | 3PL | Reverse Distributors.

Updated October 5, 2021

You can read more about this topic here:

Former Supervisory Pharmacist of Defunct New England Compounding Center Resentenced in Connection with 2012 Fungal Meningitis Outbreak - Outbreak was the largest public health crisis ever caused by a contaminated pharmaceutical drug - US DOJ

---  the original link follows below  ---

More die in fungal meningitis outbreak; state pharmacy chief fired - NBC News:

"Massachusetts officials have fired the director of the state’s pharmacy board and suspended its attorney for failing to alert them that the company at the center of an outbreak of fungal meningitis was making and distributing drugs in mass quantities even though it wasn’t licensed to do so, the Boston Globe reported Wednesday.

Federal health officials say the outbreak of fungal meningitis traced to contaminated pain injections from the pharmacy has killed 31 people. They said 424 people have been confirmed sick in 19 states, including 10 who don’t have meningitis but who have infections in the ankle, shoulder or other joints."

'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

Florida suspends compounding pharmacy operations

• CDR Training Services by CDR Resource Center. The specialists that work at CDR Resource Center have been working in the pharmaceutical industry for more than 25 years. Because of their vast experience, CDR Resource Center has been able to develop an innovative way of training candidates to prepare them for the Official State of Florida Certified Designated Representative Examination. CDR Resource Center has also developed relationships with other training providers with long standing reputable services in our industry to provide training services for California Designated Representative license applicants.

Florida suspends compounding pharmacy operations - Vitals:

"The Florida health department said in an October 26 statement that during a routine October inspection of Rejuvi it found that it had violated rules on "cleanliness of the prescription department, the dispensing of medications, the compounding of medications, and record keeping.""

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

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

FL Designated Representative - CDR Exam Prep Course  by CDR Resource Center

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

What is HMDR Exemptee Training?

• California HMDR Exemptee Training Certification Course (accepted by the California Department of Public Health - Food and Drug Branch) - Register now!

What is HMDR Exemptee Training?

SkillsPlus International Inc. is a long running provider of training to home medical device retailers (HMDR) and durable medical equipment (DME) wholesalers.

Since 2002 SkillsPlus has provided up-to-date training for their clients. This website page, California Exemptee HMDR and DME Providers Certification Course,  provides information specific to the California Exemptee certification course. For those seeking two certifications, this course also meets the requirements for the Board of Pharmacy California Designated Representative.

California requires home medical device retailers to retain an on-site Exemptee to conduct their business. The Exemptee must be physically present during all hours of operation. This course is recommended by, and meets the training requirements of, the CA Department of Public Health, and covers:

• California Code of Regulations 
• Business and Professions Code 
• Prescription Drug Laws 
• Controlled Substances 
• USP Storage Conditions 
• Health and Safety Code 

Prospective Exemptees can meet the training requirement by taking SkillsPlus Intl Inc.'s web-based, self-study class (that includes a final exam) for training certification. The class is fast, to the point, and has helped thousands of potential California Exemptees get licensed.

For more information:

California Exemptee HMDR and DME Providers Certification Course - by SkillsPlus International Inc.  (accepted by the California Department of Public Health - Food and Drug Branch)

Return Home:  The Designated Representative and Exemptee Blog

California HMDR Exemptee Training Certification Course

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

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

• California HMDR Exemptee - Online CBT Training (skillsplusinfo.blogspot.com)
• CA Home Medical Device Retailer Exemptee License Application (skillsplusinfo.blogspot.com)
• CA HMDR Facilities Must Have Policies and Procedures (skillsplusinfo.blogspot.com)
• Don't Get Caught Without A California HMDR Exemptee (skillsplusinfo.blogspot.com)
• What Is A Pharmacy Designated Representative? (skillsplusinfo.blogspot.com)

H.D. Smith to acquire West Coast wholesaler

• The top choice for CDR training! California Designated Representative Training - for wholesalers, 3PL, reverse distributors. California Pharmacy Board approved. Earns a training affidavit suitable for your Designated Representative license application. More than 7,000 students have taken state license-related training programs taught by SkillsPlus International Inc. ... ... ... ... ... ... #CaliforniaDesRep #CaliforniaDesignatedRepresentative
  

H.D. Smith to acquire West Coast wholesaler | Drug Store News:

"H.D. Smith, one of the largest pharmaceutical wholesalers in the United States, announced plans to acquire Valley Wholesale Drug in a merger agreement transaction.

The acquisition will increase H. D. Smith’s customer base in California and give the wholesaler an opportunity to expand into the Pacific Northwest, a market in which it currently has a limited reach."

'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

What Is A Pharmacy Designated Representative?

If you're new to the pharmacy world of the Designated Representative, maybe this quick introduction will help. I'm going to explain, using the California (CA) State Board of Pharmacy as the example.

According to the CA Designated Representative application form:

A designated representative is an individual who performs clerical, inventory control, housekeeping, delivery, maintenance, or similar functions related to the distribution or dispensing of dangerous drugs or dangerous devices. To work as a designated representative, you must possess and keep a current certificate as a designated representative.

There are quite a number of requirements that have to be met in order to qualify, including the following training requirements listed on the application form:

Complete a training program that, at a minimum, addresses each of the following subjects:
(A) Knowledge and understanding of California and federal law relating to the distribution of dangerous drugs and dangerous devices.
(B) Knowledge and understanding of California and federal law relating to the distribution of controlled substances.
(C) Knowledge and understanding of quality control systems.
(D) Knowledge and understanding of the United States Pharmacopoeia standards relating to the safe storage and handling of drugs.
(E) Knowledge and understanding of prescription terminology, abbreviations, dosages and format.

The trick then becomes finding a way to fulfill the training program requirement.

You might also be interested in:

CA Designated Representative online training certification - for drug wholesalers
FL Designated Representative online exam preparation - for drug wholesalers


Return Home:  The Designated Representative and Exemptee Blog

CA HMDR Exemptee online CBT training certification by SkillsPlus Intl Inc.
SkillsPlus Intl Info Blog

Related articles

• FDA warning public of risks of online pharmacies (drughealth.blogspot.com)

Florida drug database intended to save lives is barely used by doctors

Florida drug database intended to save lives is barely used by doctors - Tampa Bay Times:

"The system can help medical practitioners determine whether a patient has a legitimate medical need for these highly addictive medications — or is a drug abuser seeking the next high.

But the program came with a major loophole: Nobody is required to check it.

Now, a Tampa Bay Times investigation has discovered what experts feared — the vast majority of medical practitioners have never touched the much-touted database:"

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

FL Designated Representative online exam preparation for drug wholesalers

CA Designated Representative online training certification for drug wholesalers
CA HMDR Exemptee online e-Learning certification by SkillsPlus Intl Inc.

SkillsPlus Intl Info Blog

Price Gouging: A Black Mark On Gray-Market Distributors

Added August 24, 2017

You might also be interested in this recent article:
States Take on Drug Price Transparency, Gouging - RAPS.org

- - -

Updated August 19, 2017

The original article is now "hidden" behind a webpage sign-in.

You might also be interested in this article:
Should the FDA Regulate Drug 'Gray Markets'? (PDF)

- -  original post follow below  - -

Pharmacy Practice News - Price Gouging: A Black Mark On Gray-Market Distributors:

"In response to the report’s critical findings, Patricia Earl, a consultant to the National Coalition of Pharmaceutical Distributors, told hearing attendees, “I cannot emphasize enough the value that small or secondary pharmaceutical distributors bring to the health care system.” She said there were “thousands of small distributors that work with hospitals across the nation. To remain competitive they must comply with laws, follow pedigree and handling regulations to the letter and still offer an economical price point that allows for only a modest profit margin. If they do anything else, they run the risk of permanently losing a customer.”"

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

Training program for California Designated Representative license applicants - 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

Meningitis cases mount as ex-FDA lawyers fault agency for not stepping in

Updated February 15, 2022

The original link broke.

A lot has happened since this original post.  

Read more about the entire situation here:

New England Compounding Center meningitis outbreak - Wikipedia

---  the original post follows below  ---

Meningitis cases mount as ex-FDA lawyers fault agency for not stepping in | The Town Talk | thetowntalk.com: "

“The FDA should have put them out of business, and the state should have put them out of business. Neither of them did their job,” said Peter Barton Hutt, who was chief counsel at the agency in the 1970s.

In the wake of the outbreak, lawmakers this week are raising questions about the regulation of the compounding firms and whether the FDA should be given more oversight authority.

However, the FDA already has the power to rein in large-scale drug compounding companies under a 1938 law, Hutt said.

“The statute is clear,” Hutt said. “First, you can’t stockpile under any circumstances, and if there is an approved drug, you can’t compound a competing drug.”"

'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

Rare Fungal Meningitis Outbreak Spreads To Six States including FL

Rare Fungal Meningitis Outbreak Spreads To Six States : Shots - Health Blog : NPR:

"It's a troubling story authorities think will unfold over the next month or so. An untold number of Americans who got steroid injections in their spine to relieve back pain may end up with a rare fungal meningitis. The drug was contaminated with the spores of a common leaf mold — nobody knows how.


Dr. Lucille K. Georg/CDC - [includes a photo of the] head of an Aspergillus fungal organism, a common leaf mold that most people breathe in every day without getting sick.

So far, the Centers for Disease Control and Prevention has recorded 35 cases of the fungal meningitis in six states: Tennessee, North Carolina, Florida, Virginia, Maryland and Indiana. Five patients have died."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

FL Designated Representative online CBT exam preparation - for pharmacy wholesalers

CA HMDR Exemptee online CBT training certification by SkillsPlus Intl Inc.
CA Designated Representative online CBT training certification by SkillsPlus Intl Inc.
SkillsPlus Intl Info Blog