Plan ahead if you’re thinking about submitting a California Board of Pharmacy individual license application (e.g., California Designated Representative license).
As of this writing, here’s why:
The holiday season is here
Year-end business processes and activities could get in the way
California Designated Representative license application (wholesaler, 3PL) processing times can take some time. Based on September/October 2018 data, processing times could take anywhere between 13-39 days. If there are application deficiencies, it could add an additional 10-30 days of processing time.
The California Board of Pharmacy office relocation move was originally planned for February 2019, and could be delayed.
In a nutshell, plan ahead if you’re planning to submit a California Designated Representative license application.
“Question: I need to take a California Designated Representative training course. What kind of topics will be covered in an approved training program?
Answer: It depends on the kind of California Designated Representative license type you are applying for. In other words, the required topics are different for the wholesaler, third-party logistics provider (3PL), and reverse distributor. . . .”
The California Board of Pharmacy oversees a wide range of Designated Representative licenses, including:
Designated Representative (for wholesalers)
Designated Representative 3PL (for third-party logistics providers), and
Designated Representative Reverse Distributor
Each of the three distinct license applications requires proof of training program completion. Specifically, license applicants must submit a training affidavit with their application submission. We offer three (3) different Designated Representative training courses because each license application “type” requires the coverage of different subjects and topics.
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Florida Certified Designated Representative (CDR) application forms and candidate information booklets can lead you to outdated versions.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.”
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.
“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.”
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.”
California 3PL Provider License – CA Board of Pharmacy
ICYMI – The California Board of Pharmacy oversees 3PL providers and their Designated Representative-3PL.
“Third-party logistics provider” means an entity that provides or coordinates warehousing or other logistics services for a dangerous drug or dangerous device in intrastate or interstate commerce on behalf of a manufacturer, wholesaler, or dispenser of the dangerous drug or dangerous device, but does not take ownership of the dangerous drug or dangerous device, nor have responsibility to direct its sale or disposition. … The Designated Representative-3PL Responsible Manager must file a separate application with the board if he or she is not already licensed as a Designated Representative-3PL in California. The application form is available by selecting the following link Designated Representative-3PL Application.