FL CDR – Q & A by the Division of Drugs, Devices, & Cosmetics

The Florida Department of Business and Professional Regulation (DBPR) – Division of Drugs, Devices, & Cosmetics (DDDC) maintains a webpage full of commonly posed questions. Many of the questions are related to the Florida Certified Designated Representative (CDR) license:  FL DBPR DDDC Permitting FAQs


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Florida Certified Designated Representative (CDR) Required For Wholesale Distributors

Law books, gavel, scaleThe Florida Department of Business & Professional Regulation – Division of Drugs, Devices and Cosmetics answers the question, “Does my company need a permit?”  Their answer includes a helpful chart, definitions, and a link to relevant Florida statutes

Prescription drug wholesalers need to have a Florida Certified Designated Representative (CDR):

“CERTIFIED DESIGNATED REPRESENTATIVE

All prescription drug wholesale distributor and out-of-state prescription drug wholesale distributor permittees and applicants must designate in writing at least one natural person to serve as the designated representative for a given establishment.  Such person must have an active certification from the department (a “certified designated representative” or “CDR”).”

Source: Certified Designated Representative – Florida Department of Business & Professional Regulation

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FAQ: Who needs an HMDR License?

High tech graphic of medical devicesQUESTION: Who needs an HMDR license from the California Department of Public Health, Food and Drug Branch (CDPH/FDB)?

ANSWER: Any person conducting an HMDR business (retail facility or warehouse) in the State of California must first obtain a license from CDPH/FDB. A separate license is required for each location. The license must be renewed each year, and the license cannot be transferred to another location, business, or business owner. {FYI: Wholesalers of medical devices are not required to obtain an HMDR license, but may be required to obtain a permit with the Board of Pharmacy if they distribute prescription (Rx) devices for wholesale purposes} http://www.pharmacy.ca.gov

Sources:


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California HMDR Exemptee – Minimum Qualifications

Woman pondering a question

Many California Home Medical Device Retailer (HMDR) Exemptee applicants have questions about the minimum qualifications for Exemptee eligibility.

If you navigate to, and open up the HMDR Exemptee Application (PDF), here’s what you’ll see:

Minimum qualifications:

  • Education: High school diploma GED or equivalent. Attach copies of any applicable certifications or licenses that you may hold.
  • On-the-Job Training: Attach copies of current employer’s training records listing job-specific training provided and dates completed.
  • Work Experience: One or more years paid experience, attach dates, name(s) of employer(s), and addresses. Training must have been supervised by a licensed exemptee, Pharmacist-In-Charge or equivalent.
  • Training Programs: Indicate by yes or no the training you have completed specific to the five topics listed. Attach copies of certificates or transcripts.”

Source (as of the date of this blog post):
State of California – Health and Human Services Agency – California Department of Public Health Food and Drug Branch – Application For Home Medical Device Retailer Exemptee License – New and Renewal (Form CDPH 8695 (09/09))


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FDA publishes Q&A on DSCSA provisions – SecuringIndustry.com

FDA Logo in blue“The FDA has published a draft question-and-answer document to help guide the implementation of the US’s traceability system for medicines.

The guidance – which is aimed at wholesalers and third-party logistics (3PL) companies – is the latest information from the US regulatory on the Drug Supply Chain Security Act (DSCSA) and is open for comment until December 8.”

Read the full article: via SecuringIndustry.com – FDA publishes Q&A on DSCSA provisions.

View the FDA’s draft guidance: The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers – FDA Draft Guidance For Industry (PDF)


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CA Home Medical Device Retailer (HMDR) FAQs

Healthcare Practitioner

“The Home Medical Device Retailer (HMDR) licensing program is administered as part of the Medical Device Safety Section and is governed by law found in the California Sherman Food, Drug and Cosmetic Law.  The Sherman Law was amended in the 1999-2000 legislative session to establish the HMDR licensing program.

…  Also found below is a link to the compiled Frequently Asked Question FAQ list [PDF].  These questions were collected during the establishment of the HMDR Program and represent the most frequently answered questions documented by department staff.”

View the webpage with links to the Sherman Law and HMDR FAQs: via HMDRLawsandFAQ-EM.


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