"Board regulations (Title 16 California Code of Regulations sections 1715 and 1784), require that all licensed pharmacies and wholesalers complete a Self-Assessment by July 1 of every odd-numbered year.
The board recently updated the Self-Assessment forms through a formal rulemaking. The updated forms contain references to statutory and regulatory changes that occurred between 2011 and 2014 (inclusive).
While the rulemaking process was underway, the board accepted from pharmacies, hospital pharmacies and wholesalers completion of either the 2011 version OR the draft 2014 version: both versions have been available for use on the board’s website.
Form 17M-13: “Community Pharmacy Self-Assessment/Hospital Outpatient Pharmacy Self‐Assessment (Rev. 10/14)”
Form 17M-14: “Hospital Pharmacy Self‐Assessment (Rev. 10/14)”
Form 17M-26: Form 17M-26: “Wholesaler Dangerous Drugs & Devices Self-Assessment (Rev. 10/14).”
The board encourages all pharmacies, hospital pharmacies and wholesalers to complete the revised forms if they have not already completed the 2014 assessments. The board will no longer accept the 2011 versions of the self-assessment forms as [compliant]."
California State Board of Pharmacy Subscriber Alert - emailed to PHARM-GENERAL@DCALISTS.CA.GOV on April 25, 2016.
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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.
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.
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).
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.
A California exemptee is an employee that meets the required knowledge and training mandated by California Health and Safety Code 111656.4.
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.
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 is the abbreviation for Standard Operating Procedures. Both the Board of Pharmacy and the HMDR require SOPS.
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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