This announcement was just sent by the California Board of Pharmacy:
“Companies that do not own, but receive, store and ship prescription drugs and prescription devices into or within California need to obtain a third-party logistics provider (3PL) license immediately with the California State Board of Pharmacy.
Formerly, these entities were licensed as wholesalers or nonresident wholesalers by the Board of Pharmacy, but with passage of federal legislation in November 2013 and Assembly Bill 2605 (Bonilla) in 2014, entities that were previously licensed by the board as wholesalers need to obtain a different license as a third-party logistics provider as well as designate a responsible manager and secure licensure of specialized employees who will serve as designated representatives – 3PLs.
Wholesalers that operate as 3PLs need to work with the board to achieve compliance and become properly licensed.
“The stepped-up oversight was hastened by a new law that bolstered FDA authority. But compounders say the get-tough approach is a double-edged sword. Hospitals, doctors and patients may eventually have more confidence in compounded’ medicines, but in the meantime costs and red tape have increased. And a new batch of proposed guidelines issued by the FDA last week has set off another round of anguish.
The FDA maintains the guidelines are “critical to protecting public health.” But Scott Karolchyk of QmedRx, a compounder based in Maitland, Florida, argues “the FDA is trying to punish success. If these [guidelines] go into effect, a lot of pharmacies face onerous restrictions. And limiting good compounding pharmacies only hurts patients and their access to medications.””
Here’s an update on the status of California Board of Pharmacy sponsored legislation to enact provisions to license third-party logistic (3PL) providers as a separate class, and not as the Board had previously done under the category of wholesaler.
According to the December 17, 2014 meeting minutes of the Enforcement and Compounding Committee:
Legislation was enacted by AB 2605 (Bonilla, Chapter 507, Statutes of 2014)
The board now needs to amend its regulations to ensure that third-party logistics providers also [sic] must adhere to board regulations for all drug distributors, whether they are a wholesaler or third party-logistics provider.
There is a proposed mock-up of existing requirements for drug wholesalers that has been amended to include third-party logistics providers. This document is not yet completed as a self-assessment process is proposed much like the process required of drug wholesalers. Additionally the third-party logistic provider community needs to be advised of the developing regulations as well so that they may participate in the process. View the mock-up, starting on p158 of the meeting materials (PDF)
The board has to develop and refine requirements and adopt regulations in this area. This item will be placed on the next Enforcement Committee agenda. The next Enforcement Committee meeting date is March 26, 2015.