Showing posts with label notification. Show all posts
Showing posts with label notification. Show all posts

Friday, December 9, 2016

DSCSA Identification of Suspect Product and Notification - FDA Final Guidance

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

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

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, December 2, 2013

What To Do When Your Florida CDR Quits

What To Do When Your FL CDR Quits

Here's what the Florida Division of Drugs, Devices and Cosmetics says . . .

Customer Help:   "DIVISION OF DRUGS, DEVICES AND COSMETICS

My company is a prescription drug wholesale distributor (in-state or out-of-state). Our Certified Designated Representative (CDR) just quit. What do we do?

Notify the department within 10 business days from the CDR’s separation. Your company may continue to distribute prescription drugs in or into Florida during that 10-business day-period. After that period expires, however, your company must either (a) engage a replacement CDR and notify the department of same or (b) cease prescription drug distributions in or into Florida.

The Department can, upon written request to appropriate personnel, provide a list of all unaffiliated CDR’s."

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):

Friday, September 13, 2013

On-Line Change of Address Form - CA Board of Pharmacy

Updated June 12, 2026

The original links broke.

You can still go to the Change of Address form here:

Change of Address/Email/Name for a Personal License:
https://www.pharmacy.ca.gov/about/change_of_address_personal.shtml

---  the original post follows below  ---

Change of Address Form (online) - California Board of Pharmacy

The following link will take you to a webpage that gives an overview of the California laws and regulations governing Board of Pharmacy address change reporting requirements:

Board of Pharmacy - Technical Help:

"You are required to notify the board of any change in your address within 30 days. Change of address may be made on-line or in writing to the board."

If you are a licensed California Designated Representative, or other affected party, follow this link to the California Board of Pharmacy - On-line Change of Address Form.

Return Home:  The Designated Representative and Exemptee Blog

Training program for California Designated Representative (including 3PL) license applicants

Return Home:  The Designated Representative and Exemptee Blog

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Wednesday, September 11, 2013

Business Owners May Face $100-Per-Day Penalty Under ObamaCare | Fox

Updated September 30, 2025

The original link broke.

---  the original post follows below  ---

Business Owners May Face $100-Per-Day Penalty Under ObamaCare | Fox Small Business Center:

"Small business owners who thought they were off the hook for ObamaCare regulations until 2015 may be in for an expensive wake-up call next month.

Beginning Oct. 1, any business with at least one employee and $500,000 in annual revenue must notify all employees by letter about the Affordable Care Act’s health-care exchanges, or face up to a $100-per-day fine."


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, February 13, 2012

Change of Designated Representative-In-Charge - California

Updated July 18, 2020
When key employees move on or are terminated, there are Designated Representative implications that you need to consider. Read on, as the consequences could invoke disciplinary action.

According to the California Board of Pharmacy Change of PIC/DRIC/RMG/Professional Director webpage:

Change of Designated Representative-in-Charge (DRIC)

"Business and Professions Code Sections 4160(f), states, “A wholesaler shall notify the board in writing, on a form designed by the board, within 30 days of the date when a designated representative-in-charge ceases to act as the designated representative-in-charge, and shall on the same form propose another designated representative or pharmacist to take over as the designated representative-in-charge. The proposed replacement designated representative-in-charge shall be subject to approval by the board. If disapproved, the wholesaler shall propose another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a designated representative-in-charge is approved by the board.”  The DRIC serves as supervisor or manager and is responsible for ensuring the wholesaler’s or veterinary food-animal drug retailer’s compliance with all the state and federal laws and regulations pertaining to practice and the applicable license.

If the DRIC is a pharmacist in the home state of the nonresident wholesaler license, is currently associated with an active nonresident wholesaler license, and has electronic fingerprints on file with the California State Board of Pharmacy, new fingerprints may not be required.  You may request a set of the board fingerprint cards if you do not hold a current California pharmacist license and are not currently associated as a DRIC to a nonresident wholesaler
Return Home:  The Designated Representative and Exemptee Blog

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

If you are also applying for a California Designated Representative License, you might also need required training. Take this online course to earn a Board-accepted training affidavit to include in your Designated Representative license application packet:  California Board of Pharmacy Designated Representative Training Courses - presented by SkillsPlus International Inc.
Training programs for California Designated Representative license applicants - Earn 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):


Wednesday, July 14, 2010

How To Renew Your CA Pharmacy Designated Representative License

According to the CA Board of Pharmacy:

"Approximately 6 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." (Source: Information for Licensees)
In case you need the Request for Renewal form, go here, to License Renewal, to find the link to the most current version of the Request for Renewal of Designated Representative form.

Return Home:  The Designated Representative and Exemptee Blog
Return Home (mobile): http://exemptee.mofuse.mobi/
Custom Search

From SkillsPlus International Inc.