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.
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.
There are new requirements under the Drug Supply Chain Security Act (DSCSA) for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). Some requirements began in November 2014 and several key requirements begin at various stages in 2015. The new requirements, development of standards, and the system for product tracing will continue to be phased in over the next nine years. FDA will continue working with trading partners and other stakeholders to effectively implement the new requirements.
“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.”
“It has been the contention of DEA and the Dept. of Justice for several years that companies involved in shipping and delivering controlled substances must ensure that both providers and shipment recipients are authorized (licensed) to make or receive these shipments. In “normal” distribution, a licensed manufacturer of such drugs ships them to a licensed pharmacy; paperwork follows the shipment, at least when the shipping and receiving is occurring within US borders. In the case of illicit online pharmacies (which, technically, aren’t allowed to fill prescriptions unless they are sited in the US), offshore organizations accept orders from individuals—especially via the Internet—and then look to carriers like FedEx to complete the shipment.”