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.

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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):

Tuesday, August 22, 2017

FDA Offers Draft Guidance to Further Secure Drug Supply Chain | RAPS


Updated October 13, 2023

One of the original links broke.

You might also be interested in:

---  the original post follows below  ---

Read the full article: FDA Offers Draft Guidance to Further Secure Drug Supply Chain | RAPS:

"Last Friday, FDA released new draft guidance to help industry, state and local governments categorize the entities in the drug supply chain in accordance with the DSCSA and help clarify which companies are engaged in activities that require licensure and annual reporting.

The 18-page draft, titled "Identifying Trading Partners Under the Drug Supply Chain Security Act," notes the confusion related to defining wholesale distributor and wholesale distribution, as well as confusion over what an affiliate of a manufacturer means."

'via Blog this'

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Training program for California drug or device wholesaler license applicants
Training program for California third party logistics (3PL) providers license applicants


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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, August 18, 2017

CMS revamps claims review process | HME News

Read the full article: CMS revamps claims review process | HME News:

"Claims submitted by providers that have the highest claim error rates or billing practices that vary significantly from their peers will soon face increased scrutiny, CMS has announced.

As part of an expanding “Targeted Probe and Educate” program, the Medicare Administrative Contractors will identify these providers through data analysis."

'via Blog this'

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Training program for California Home Medical Device Retailer (HMDR) license applicants - Earn a completion certificate

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

Thursday, August 10, 2017

Will Traceability Services Be Outsourced? | Pharmaceutical Technology

Outsourcing Traceability Services

Read the complete article: Will Traceability Services Be Outsourced? | Pharmaceutical Technology:

. . . "and in the future, we can expect some other US 3PLs to offer a similar service. Woodfield hosts TraceLink for each client and manages it for clients, along with other services."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

Earn a training affidavit - For California Designated Representative-3PL 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):

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