Pay Attention To The Version! – Florida Certified Designated Representative (CDR)

Beware! – There are multiple versions of forms and booklets for Florida Certified Designated Representative (CDR) license applicants

Florida state websites are getting reorganized and redesigned. As a result, an internet search for Florida Certified Designated Representative (CDR) application forms and candidate information booklets can lead you to outdated versions.

At the time of writing this post, there are CDR forms and publications that have an effective date of December 2017 or January 2018.  In my small sampling of search results, I was able to locate a form as old as 2014.

If you’re not sure you’ve got the latest forms or publications, here’s what the 2018 application form says, “If you have any questions or need assistance in completing this application, please contact the Department of Business and Professional Regulation, Division of Drugs, Devices and Cosmetics, at 850.717.1800.”


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California Designated Representative Training Programs

Find California Designated Representative Training Programs – Earn a training affidavit

Question:  Who offers California Designated Representative training courses?

AnswerSkillsPlus International Inc. offers these popular online classes:


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Where To Get Live Scan Fingerprinting

California Designated Representative license applicants who are California residents must only use Live Scan fingerprinting (refer to the various Designated Representative license applications for additional information).

Here’s the link to find Live Scan locations in California


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California HMDR Laws for 2018

California HMDR Laws for 2018

New CA Home Medical Device Retailer (HMDR) Legislation – Effective January 1, 2018

Read the full text of the bill:   AB 1387, Arambula. Home medical device retail facility business: licensing: inspections.

The Sherman Food, Drug, and Cosmetic Law, among other things, prohibits a person from conducting a home medical device retail facility business in the state without a valid license from the State Department of Public Health. Existing law requires the department to inspect each place of business prior to issuing a license, and further requires the department to inspect each licensee at least annually.

This bill would modify, until January 1, 2023, the requirement for the department to inspect a licensed home medical device retail facility business if it is accredited, as specified, by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services. If so accredited, the bill would authorize the department to conduct an inspection only upon a complaint made to the department regarding the licensee. For a licensee that is not so accredited, the bill would continue to require the department to conduct an inspection at least annually.

Source: The legislation above is referenced on the CA HMDR Program website


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AmerisourceBergen snaps up independent wholesaler H. D. Smith for $815M | FiercePharma

“In the face of a tough pricing market that has weighed on generic drugmakers and their distributors, wholesaling giant AmerisourceBergen has decided to go out and snarf up a bigger share. It will pay $815 million in cash for H. D. Smith, the largest independent drug distributor left in the U.S.”

Source: AmerisourceBergen snaps up independent wholesaler H. D. Smith for $815M | FiercePharma


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Amazon Has Obtained Pharmaceutical Wholesaler Licenses In 12 States – Consumerist

“The Post-Dispatch was able to confirm through public records that Amazon has been approved as a pharmaceutical wholesaler in the states of Alabama, Arizona, Connecticut, Idaho, Louisiana, Michigan, Nevada, New Hampshire, New Jersey, North Dakota, Oregon, and Tennessee. An application in Maine is still pending.”

Source: Amazon Has Obtained Pharmaceutical Wholesaler Licenses In 12 States – Consumerist


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New ATA report takes a deep dive into the ongoing truck driver shortage – Logistics Management

“So, what about those future numbers? You may want to cover your eyes, as they are not pretty. According to the ATA, the driver shortage is projected to hit 50,000 by the end of 2017, with the possibility, if things remain the same, that the number could exceed 174,000 by 2026.”

Source: New ATA report takes a deep dive into the ongoing truck driver shortage – Logistics Management


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California wants to pull Cardinal Health license over ‘red flags’

“The state of California wants to revoke the wholesale license for a facility run by Cardinal Health, one of the nation’s largest pharmaceutical distributors, for failing to note a series of unusual sales of an opioid painkiller and three other tightly regulated medicines to a pharmacy.”

Source: California wants to pull Cardinal Health license over ‘red flags’


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FDA Steps in to Regulate Microneedling Devices | RAPS

“The US Food and Drug Administration (FDA) on Thursday issued a draft guidance detailing when it considers “microneedling” products to be medical devices and subject to regulation.”

Read the full article – Source: FDA Steps in to Regulate Microneedling Devices | RAPS

Read the guidance:  Regulatory Considerations for Microneedling Devices – FDA (PDF)


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FDA Clarifies DSCSA Entities And Trading Partners

Entities & Trading Partners Defined Under The DSCSA

“The Food and Drug Administration (FDA or the Agency) is issuing this guidance to assist industry and State and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (DSCSA). DSCSA establishes product tracing requirements for certain trading partners in the drug supply chain, including manufacturers, repackagers, wholesale distributors, and dispensers. DSCSA also requires that trading partners of manufacturers, wholesale distributors, dispensers, and repackagers must meet the applicable requirements for being “authorized trading partners.” DSCSA also requires FDA to issue regulations that establish Federal standards for the licensing of wholesale drug distributors (WDDs) and third-party logistics providers (3PLs). The Agency is currently drafting these regulations. This guidance, when finalized, will explain FDA’s current thinking on how licensing and certain other requirements apply to entities that may be considered trading partners in the drug supply chain.

This guidance is intended to (1) assist industry and State and local governments in understanding the applicability of DSCSA requirements to the various types of entities that take part in the distribution of prescription drugs in the United States, and (2) help clarify for industry whether they are engaged in activities that require licensure and annual reporting, as well as other requirements related to being an authorized trading partner in the drug supply chain. The guidance does not address all requirements described in DSCSA, but is limited to describing the activities that would determine what type of trading partner an entity may be and the applicable requirements under DSCSA.”

Source:
Identifying Trading Partners Under the Drug Supply Chain Security Act – Guidance for Industry – DRAFT GUIDANCE (PDF)


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