On October 23, 2017, a company that developed software to track and trace pharmaceuticals filed a complaint against a pharmaceutical distributors trade association that currently dominates the market for such software, alleging a conspiracy to lock up long-term contracts with customers and exclude competition in violation of the Sherman Act and the Virginia Antitrust Act.  Tracelink, Inc. v. Healthcare Distribution Alliance, Case No. 1:17-cv-01197-AJT-IDD (E.D. Va. Oct. 23, 2017). Continue Reading Pharma Distributors Trade Association Sued for Conspiracy to Exclude Competition for its Track and Trace Software

Last week FDA published a notice of public meeting and a request for comments regarding certain aspects of the Drug Supply Chain Security Act (DSCSA).  The meeting will take place on October 14, 2016 at the Agency’s campus in White Oak, Maryland.  This webpage provides further information for potential attendees.  The upcoming event will be the first public meeting convened by FDA to address DSCSA-related issues.  The DSCSA requires the Agency to conduct at least 5 such meetings during the lengthy implementation period in order to keep it engaged and communicating with relevant stakeholders.

As we have described previously (see here and here), the goal of the DSCSA is to implement enhanced security and accountability for prescription drugs throughout the U.S. pharmaceutical supply chain.  It created phased-in obligations for various “trading partners,” such as manufacturers, distributors, and dispensers, over a 10-year period, beginning with the law’s passage at the end of 2013.

Among many others, one of the impending obligations facing industry is the requirement that manufacturers and repackagers affix or imprint a product identifier, at the package level, to prescription drug products that they introduce into commerce.  This product identification step is also referred to as “serialization,” and eventually trading partners will only be allowed to sell and buy serialized drug products.  Manufacturers and repackagers must comply with their initial product serialization mandates by November 2017 and November 2018, respectively. Continue Reading FDA Holding its First Public Meeting on Drug Product Identification Requirements in October

Last week FDA took another important step in implementing the complex and interlocking provisions of the Drug Supply Chain Security Act (DSCSA).  We have previously discussed the new Federal drug traceability requirements and their impact on pharmacies and dispensers (see here and here).  Wholesale distributors and third-party logistics providers (aka “3PLs”) are required under the law to submit their facilities’ State licensure information annually to FDA beginning on January 1st (for wholesale distributors) and November 27, 2014 (for 3PLs), and FDA must make that information available to the public.  For some wholesale distributors, there may be numerous State licenses listed due to the fact that many States require not only resident distributors to be licensed, but also non-resident facilities that may be distributing prescription drugs into the State.

This week’s big news is that the DSCSA-mandated public licensure database is finally available via FDA’s website.  Users either can query the database when searching for a particular company here or download the entire data set as an Excel file from this page.  Although technically the law only requires a public wholesale distributor database, FDA determined that making the 3PL information public as well served the law’s goals, and it stated in a December 2014 policy document that: “The ultimate goal is for the public database to serve as a single repository of licensing and facility information for wholesale drug distributors and 3PLs conducting business in the United States.” Continue Reading FDA Releases First Wholesaler and 3PL Facility Licensure Data to the Public

On June 30, 2015, a mere day before the product tracing deadline for dispensers was to go into effect, FDA published a compliance policy guidance that delays enforcement of the applicable product tracing requirements until November 1, 2015 (Compliance Policy).  As we previously discussed, pursuant to the Drug Supply Chain Security Act, most pharmacies in the U.S. are required to have systems in place by July 1, 2015, to receive so-called “3T information” (that is, Transaction History, Transaction Statement, and Transaction Information) regarding the prescription drugs they purchase from suppliers.

In the Compliance Policy, FDA notes that dispensers have expressed concern that electronic systems used to exchange, capture, and maintain product tracing information will not be operational by the original July 1 deadline. Although the agency acknowledges that paper-based transmission may be acceptable in some cases, FDA also notes that many dispensers intend to utilize electronic systems to capture and maintain the 3T information. Accordingly, the Compliance Policy concedes that dispensers may need additional time beyond July 1, 2015 to work with their trading partners to ensure that the 3T information is captured and maintained as required by the DSCSA.

Consequently, FDA does not intend to take action prior to November 1, 2015, against dispensers who, in either case: (i) accept ownership of a covered drug product without receiving the 3T information; or (ii) do not capture and maintain the 3T information provided by the dispenser’s trading partner. Continue Reading FDA Provides 11th Hour Delay of Product Tracing Requirements for Pharmacies

Beginning July 1, 2015, most pharmacies in the U.S. will be required to have systems in place to receive transaction information regarding the prescription drugs they purchase from suppliers.  The requirement stems from a 2013 federal law called the Drug Supply Chain Security Act (DSCSA), enacted as one component of the Drug Quality and Security Act.  In addition to accepting the so-called “3T” information (Transaction History, Transaction Statement, and Transaction Information) for each prescription drug it purchases on or after July 1, covered pharmacies also must have systems in place to segregate and investigate suspect products.

Continue Reading Is Your Pharmacy Ready for Drug Supply Chain Integrity?