Can Trump/Azar/Sharpless Eliminate Parts of the DSCSA to Enable Importation? - RxTrace

California Designated Representative Online Training Classes. Largest selection of Board-approved courses for: wholesalers, 3PL, reverse distributors. Earns a training affidavit accepted by the Board.

Read the full article: Can Trump/Azar/Sharpless Eliminate Parts of the DSCSA to Enable Importation? - RxTrace.com

According to Dirk Rodgers:

"Can President Trump, HHS Secretary Azar and Acting FDA Commissioner Sharpless eliminate/adjust/reinterpret any part of the Drug Supply Chain Security Act (DSCSA) to allow Florida, Colorado, Vermont, Maine or any other US state or territory to import drugs from foreign markets? Let’s take a closer look at what’s been going on recently with the idea of importing drugs from other markets in an attempt to help American citizens buy them at a lower cost."

His analysis of the situation is a worthy read.

You might also be interested in his book, "The Drug Supply Chain Security Act Explained: Second Edition, Plus Explanations Of Key FDA DSCSA Guidances 2nd Edition:"

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California Designated Representative Online Training Classes. Largest selection of Board-approved courses for: wholesalers, 3PL, reverse distributors. Earns a training affidavit accepted by the Board.

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):

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).
DRIC: Designated Representative In Charge (DRIC)
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.)
NCDQS: At the National Coalition for Drug Quality & Security (NCDQS), our accreditation programs for wholesale drug distributors go beyond the most stringent state and federal regulations to include best practices in maintaining the quality and security of drug products.
SOP: SOP is the abbreviation for Standard Operating Procedures. Both the Board of Pharmacy and the HMDR require SOPS.
VAWD: The Verified-Accredited Wholesale Distributors (VAWD) accreditation is for facilities engaged in the act of wholesale drug distribution. The VAWD program has been rebranded as the "NABP Drug Distributor Accreditation" program.; 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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Monday, August 5, 2019