California Designated Representative-Reverse Distributor License Application
Mar 12, 2018. The California Board of Pharmacy has posted the California Designated Representative-Reverse Distributor license application form (desig_rep_rd.pdf) on its website.
California Designated Representative Reverse Distributor Training Program
Jan 6, 2018. Statutory changes to California pharmacy law (effective January 1, 2018) specify the details of a Designated Representative-Reverse Distributor training program, and what must be covered in such a course.
California Designated Representative-Reverse Distributor License Created
Dec 22, 2017. California Senate Bill - SB 752 (Chapter 598, Statutes of 2017, Stone) Designated Representative-Reverse Distributor has been "chaptered" by the Secretary of State (enacted October 8, 2017). It includes the creation of a designated representative-reverse distributor license. At a high level:
Section 4040.5 of the Business and Professions Code is amended to read: 4040.5. "Reverse distributor" means every person who acts as an agent for pharmacies, drug wholesalers, third-party logistics providers, manufacturers, and other entities by receiving, inventorying, warehousing, and managing the disposition of outdated or nonsaleable dangerous drugs or dangerous devices.
Section 4022.6 is added to the Business and Professions Code, to read: 4022.6. "Designated representative-reverse distributor" means 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. A pharmacist fulfilling the duties of Section 4053.2 shall not be required to obtain a license as a designated representative-reverse distributor.
FDA Posts Wholesale Distributor and 3PL License Database
Oct 7, 2015. In addition to establishing standards for licensure of wholesale distributors and third-party logistics providers, the DSCSA requires wholesale distributors and third-party logistics providers to report licensure and other information to FDA annually. FDA - Wholesale Distributor and Third-Party Logistics Providers Reporting
New CA Designated Representative-3PL Training Course Announced
Mar 11, 2015. New! Learn more, and buy now: California Designated Representative-3PL Certification Course
New CA Licenses Required For Third-Party Logistics Providers (3PLs)
Feb 21, 2015. On February 20, 2015, the California Board of Pharmacy announced that third-party logistics providers (3PLs) must obtain a third-party logistics provider license, as well as designate a responsible manager, and secure licensure of specialized employees who will serve as designated representatives-3PLs (DR-3PL). DR-3PL applicants must provide proof of DR-3PL training. SkillsPlus Intl Inc. is currently developing a DR-3PL training course. Their course is scheduled to launch as an online class in the 2nd quarter of 2015. Read a blog post about California 3PL licensing.
New Laws for 2015 - California Board of Pharmacy
Jan 15, 2015. Just published, New Laws for 2015 from the CA Board of Pharmacy (PDF).
California's E-Pedigree Law Preempted
Feb 11, 2014. On November 27, 2013, President Obama signed Public Law 113-54. This law contains provisions for a national track and trace system for prescription medication. Included within this law are provisions that preempt California's e-pedigree requirements. These provisions are in addition to those in the California Business and Professions Code that also preempt California's provisions should federal legislation in this area be enacted. The California Board of Pharmacy has posted a public notice about the inactivation of California's e-pedigree provisions. Learn more: Public Notice - California's E-Pedigree Law Preempted
2014 CA Board of Pharmacy Laws
Newly Posted - FL CDR Candidate Info Booklet
Jul 29, 2013. The Division of Drugs, Devices and Cosmetics just posted a new version of the FL CDR Candidate Info Booklet (effective July 25, 2013). Here's how to view the new CIB: Go to the Department's official website, then use their Search feature (search for this keyword, "CDR CIB").
FDA Inspects Compounding Pharmacies
Mar 3, 2013. The FDA is launching an aggressive surprise inspection campaign of compounding pharmacies. The inspections started mid-February and are expected to continue for several months. The FDA has posted their findings (i.e., observations) of some pharmacies on the FDA website, by way of FDA Form 483 Observations - 2013 Pharmacy Inspections.
New Compounding Drug Products Regulation
Feb 12, 2013. This has just been posted, CA Board of Pharmacy - Regulations Approved in 2013 - Compounding Drug Products. You'll find all related proceedings and documents. The most important thing to know is that it becomes effective, April 1, 2013.
2013 CA Board of Pharmacy Laws
The Designated Representative Institute Launches
Jan 1, 2013. SkillsPlus International Inc. has created a dedicated website, www.desrep.org, to support the informational needs of Designated Representatives. On this dedicated website, you will find the answers to many questions about the training requirements of Designated Representatives, the application process, and many other frequently asked questions. As always, if you can't find the answer to your questions, you're always welcome to give the Institute a call at 415-948-5220.
For additional information, contact Allan Dewes: (415) 948-5220 or firstname.lastname@example.org
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