“The Trump Administration wants to start a drug-importation program from Canada for both small-molecule and biologic products. The program would be a “time-limited Section 804 importation program” (SIP), with the SIP program sponsored by “a pharmacist, a wholesaler, or another State or non-federal governmental entity” and subject to FDA review. Additional language in the notice of proposed rulemaking (NPRM) gives guidance on how manufacturers themselves could set up reimportation. The NPRM is available in draft form today (Dec. 18), and is expected to be published officially in the Federal Register on Dec. 23.”
“The US FDA published a compliance policy final guidance document on September 23, 2019, announcing a one-year enforcement discretion for the Wholesale Distributor Verification Requirement for Saleable Returned Drug Product.
If you’re a wholesaler or a manufacturer rushing to meet the November 2019 deadline, this guidance is significant. But before you breathe a sigh of relief, you need to read the entire guidance document and the entirety this LSPediA article.”
“Supply chain theft is estimated at $35-40 billion per year in the US, and today’s threats to the commercial supply chain are different than those of the past. Logistics companies are perfect targets, and those that aren’t aware of the changes are more likely to fall prey.”
“Brandman discussed why theft-related loss is getting worse, and said that the value of the product plus a low risk factor, lax security and an inadequate criminal justice system equals high gain, low risk. Plus, says Brandman, the internet combined with small parcel delivery service make it easy to distribute stolen goods. Thieves – often internal – who work together can result in significant loss to the company.”
The Growing Trend of PBM Track-And-Trace Audits – Frier Levitt
“Pharmacies are being asked [to] provide transaction history, transaction information, and transaction statement, and to maintain such records for not less than six years after the transaction.”
“Pharmacies are expected to ensure that wholesalers provide the aforementioned information at the time of purchase or be in a position to provide this information at the time of a request. Such requests are being made despite pharmacies having purchased from duly, licensed, and verifiable wholesalers.”
To be in full compliance with pharmacy law, refer to Business and Professions Code (BPC) section 4059.5(a), which states:
“Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and shall be delivered to the licensed premises and signed for and received by a pharmacist.” (Emphasis added.)
The big license aftershock following the DSCSA earthquake came when the FDA redefined the parameters of 3PL companies. Before the passage of DSCSA, 3PL companies could be licensed as a wholesaler. Now, that’s no longer the case.”
Read the entire article to learn how the DSCSA impacts third-party logistics providers (3PLs).
“Another area of interest for TraceLink is blockchains, the online, distributed ledger systems that power cryptocurrencies such as Bitcoin. TraceLink is developing blockchain-based software to help the pharma industry meet certain track and trace requirements in the U.S. Drug Supply Chain Security Act, Dahod says. He says the company will release more details about the project by the end of the year.”
“A wholesaler, upon discovery, shall notify the board in writing of any suspicious orders of controlled substances placed by a California-licensed pharmacy or wholesaler by providing the board a copy of the information that the wholesaler provides to the United States Drug Enforcement Administration. Suspicious orders include, but are not limited to, orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.”
The Board requests, ” . . . that reports include explicit information as to why the wholesaler deemed the order suspicious. For example, indicate if (1) the order was of an unusual size, (2) the order deviated substantially from the normal pattern, or (3) the order was of an unusual frequency.”
Reference: On Oct.
7, 2017, Governor Brown signed
into law Assembly Bill 401.
This bill added Business and
Professions Code section 4169.1
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.