February 2010 | Designated Representative and Exemptee

Tuesday, February 2, 2010

It Is Up To You - To Renew Your Designated Representative License

The CA Board of Pharmacy will mail you a renewal application to your last known address of record, six (6) weeks before your Designated Representative license expires.

If for some reason you don't receive the renewal application, you're still responsible for renewing on time. Here's how, according to the Board:

"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."

Download the Request for Renewal of Designated Representative form

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Glossary - Exemptee & Designated Representative

Computer Based Training (CBT): This is closely related to other e-learning or eLearning terms, such as: online training, web-based training (WBT), internet-based training (IBT), digital training, virtual training, e-training (technology based traiing, TBT). e-learning refers to all forms of electronically supported learning and teaching.
Designated Representative: A California 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.
Designated Representative-3PL: An individual approved by the board to provide sufficient and qualified supervision of a third-party logistics provider’s place of business. The designated representative-3PL shall protect the public health and safety in the handling, storage, warehousing, distribution, and shipment of dangerous drugs and dangerous devices. (CA BOP).

Designated Representative-Reverse Distributor: An individual to whom a license has been granted pursuant to Section 4053.2, who is responsible for supervision over a licensed wholesaler that only acts as a reverse distributor (CA Board of Rx - Desig Rep RD).
e-Learning: Also referred to as eLearning. A wide set of applications and processes, such as Web-based learning, computer-based learning, virtual classrooms, and digital collaboration.
Exemptee: A California exemptee is an employee that meets the required knowledge and training mandated by California Health and Safety Code 111656.4.

HMDR: Home Medical Device Retailer (HMDR) Licensing Program. This Program licenses all California and Out-of-State facilities and businesses who supply medical devices or durable medical equipment for use in the home to treat acute or chronic illnesses or injuries.
Manufacturer: California law defines a “manufacturer” as any person who prepares, derives, produces, compounds, or repackages any drug or device except a pharmacy that manufactures on the immediate premises where the drug or device is sold to the ultimate consumer. (B&P § 4033(a), (b), (c); see also H&S § 109970.)
SOP: SOP is the abbreviation for Standard Operating Procedures. Both the Board of Pharmacy and the HMDR require SOPS.
Wholesaler: Under California law, a “wholesaler” is any person who acts as a wholesale merchant, broker, jobber, customs broker, reverse distributor, agent, or a nonresident wholesaler, who sells for resale, or negotiates for distribution, or takes possession of, any dangerous drug or device. (B&P § 4043(a).)

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Designated Representative and Exemptee

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Tuesday, February 16, 2010

New - California 2010 Lawbook for Pharmacy - free pdf

Tuesday, February 2, 2010

It Is Up To You - To Renew Your Designated Representative License

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