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Despite Exemptions, Practitioners Play a Vital Role in DSCSA Success

By November 8, 2016March 2nd, 2021DSCSA, Serialization, Track and Trace

The Drug Supply Chain and Security Act (DSCSA) is a complex piece of legislation. It was designed to make significant product safety improvements for a giant industry, one that impacts virtually every person in this country, and around the world.

A regulatory act on that scale requires major investments for impacted businesses. In order to get compliant, every player in the industry – from global organizations to small businesses – needs to put time, money, and significant effort into updating processes, finding and installing new systems, and training people. But while the DSCSA covers every link in the drug supply chain, it left doctors and clinics exempt from major requirements. Here’s the relevant content, listed in DSCDSA 582(d)(5):

‘‘(5) EXCEPTION.—Notwithstanding any other provision of law, the requirements under paragraphs (1) and (4) shall not apply to licensed health care practitioners authorized to prescribe or administer medication under State law or other licensed individuals under the supervision or direction of such practitioners who dispense or administer product in the usual course of professional practice.

In the above text, paragraph (1) refers to product tracing and paragraph (4) refers to product verification.

What this means is that supply chain partners – manufacturers, repackagers, wholesale distributors, and dispensers – are required to meet four criteria: 1) product tracing, 2) shipping and receiving only serialized products (after November 2017), 3) working only with authorized trading partners, and 4) product verification. But practitioners – doctors’ offices and clinics without in-house pharmacies – are only required to meet one of those criteria (for the time being): working with authorized trading partners.

Patients Pay the Price When Practitioners Don’t Comply

Can you transform something as huge and complex as the pharmaceutical supply chain while exempting those who actually administer drugs to patients? The DSCSA demands stringent measures from manufacturers, repackagers, wholesale distributors, and dispensers but leaves practitioners shielded from the 3Ts (product trace) and product verification requirements. The reasoning has never been stated outright. One can speculate that the FDA does not want barriers between physicians and patients needing life-saving drugs, or it could be that they don’t want to overburden small practitioners who simply don’t have the means to perform product trace.

Practitioners need only comply with one requirement – do business with authorized trading partners. But perhaps this message failed in its delivery. Earlier this year, the FDA cracked a case that involved an illegitimate business selling counterfeit drugs to practitioners after the DSCSA became effective:

FDA Issues Letters to Doctors Who May Have Purchased Counterfeit or Unapproved Prescription Drugs

The article goes on to say that the FDA sent out 1,300 letters to clinics and physician offices to inform them that they may have secured pharmaceutical products from rogue distributors. Such distributors pose a serious risk to patients because they traffic in drugs that may:

  • Be fake, contaminated, ineffective, or otherwise unsafe
  • Not have been evaluated by FDA for safety and efficacy
  • Not contain the appropriate amount of active ingredients
  • Contain harmful ingredients

For Practitioners, Finding Licensed Suppliers Is Easy

To help those practitioners maintain the integrity of the drug supply chain, the FDA has compiled two lists of authorized drug distributors, one federal and one by state:

As of today, wholesale distributors and 3PLs have registered more than 11,000 licenses in the FDA’s database.

The DSCSA gives the FDA authority to find and shut down illegal drug trade operations. Both local and federal FDA agents will not hesitate to investigate any suspect products at any level of the pharma supply chain.

Doing business with authorized trading partners is an essential and critical requirement of the DSCSA. Businesses that have not implemented processes and systems to control who they are ordering from and who they are shipping too should do so quickly.

How LSPediA Can Help

If you’re a part of the pharmaceutical supply chain, you know that complying with regulations and meeting standards around serialization and traceability is complicated. But ensuring you have the right systems and processes in place is also one of the most important tasks your business undertakes. Your reputation with partners and patients, and your bottom line, are all at stake.

To get your business on the road to DSCSA compliance, contact LSPediA. We can ensure you understand and successfully implement a DSCSA strategy using our industry-tested serialization toolkits and our new, innovative traceability solution, Rx Chain.

 

About LSPediA – Life Sciences Solutions

LSPediA is a leading provider of enterprise software and services designed for pharmaceutical manufacturers, wholesale distributors, and dispensers. With LSPediA, customers can better implement serialization and aggregation processes to meet global regulations, DSCSA requirements, and future track-and-trace mandates.

We value long-term relationships and work with our clients’ internal teams to properly define roadmaps, create architectures, and implement systems that align to vital business goals, ultimately helping them derive maximum value from their investments, both now and well into the future.

For more information about LSPediA, call +1 (248) 973-2008, email [email protected], or visit our website at www.lspedia.com.

For additional information, contact: Julianne Jahn [email protected]