Responsibilities under the Drug Supply Chain Security Act — Is your pharmacy compliant?

August 2, 2019By Independent Pharmacy, Preparing for Track and Trace blog series, Resources focused on Independent Pharmacy

By Brittany Benson, CLSSS, Lean Project and Research Specialist, for the Preparing for Track and Trace blog series

Have you heard of the Drug Supply Chain Security Act, and do you realize how it is already impacting your pharmacy operation? This post kicks off a blog series — Preparing for Track and Trace — that will help you understand the ins and outs of the legislation and what it means for your business.

In the early 2000s, illegitimate, counterfeit, and adulterated drugs were becoming a large issue across the pharmaceutical supply chain, so the government, with the support of several leading trade associations, stepped in to help secure our nation’s drug supply.

In 2013, the Drug Quality Security Act (DSQA) was enacted, consisting of Title I, The Compounding Quality Act that went into effect at that time and Title II, the Drug Supply Chain Security Act (DSCSA). The DSCSA outlined requirements for all pharmaceutical trading partners, which includes manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers.

These requirements began rolling out in stages beginning in 2014 and will continue until 2023, when all aspects of DSCSA will be fully enacted.pharmacist

During the past five years, all trading partners have had to make some adjustments in preparation for the regulations. And for pharmacies (which DSCSA defines as dispensers) there are still some critical dates on the horizon. We’ll walk through those dates in a future post.

Within this first blog we will focus on your responsibilities today as a dispenser of pharmaceutical drugs under DSCSA.

1. Confirm that the entities you do prescription business with are licensed or registered. Don’t make assumptions. It is entirely your responsibility to make sure the trading partners you do business with meet the criteria. Here is where to search for the information about the different types of trading partners:

  • Manufacturers and Repackagers: Search for DECRS at www.FDA.gov. DECRS stands for Drug Establishments Current Registration Site.
  • Wholesaler Distributors and Third-Party Logistics Providers: Search for WDD/3PL database at www.FDA.gov. This is where the FDA’s wholesale drug distributor and third-party logistics reporting database is stored.
  • Dispensers: Check a pharmacy’s licensing through their respective state authority.

2. Receive, store, and provide product tracing documentation. Under DSCSA, prescription drugs must be traced as they make their way through the supply chain. This part is often called “track-and-trace.” Dispensers must do the following:

  • Accept prescription drugs only when they have three pieces of product tracing documentation: transaction information (TI), transaction history (TH), and transaction statement (TS). These collectively are called T3 data. Don’t accept drugs from trading partners that don’t supply all three pieces of transaction data to you.
  • Store the T3 data you receive in either paper or electronic format for no less than six years. Your business must store it – don’t rely on a trading partner to supply it later if needed. You only have two days to respond to a request by the FDA, and penalties are steep.
  • If you sell the drug to another trading partner, you will need to provide all of the T3 information on that product. If you dispense to a patient or sell to a pharmacy for dispensing to a specific patient, you don’t have to provide the T3 data. You do however, still need to keep the T3 data for the 6 years previously mentioned.

3. Investigate and properly handle suspect and illegitimate drugs. You need to have a standard operating procedure (SOP) in place to look into and handle suspect and illegitimate prescription drugs within 24 hours. This includes drugs that could be counterfeit, diverted, stolen, intentionally adulterated, or unfit for distribution. Your SOP must quarantine and investigate the aforementioned drugs. If you find a drug to be illegitimate, you must work with the manufacturer and take steps to make sure no patients receive the drug. You are also responsible for notifying the FDA (using Form FDA 3911) and the trading partners you purchased the drug from or sold the drug to.

In the next post in this series, we will dive more deeply into the T3 documentation, how to know when to suspect a drug is illegitimate, and touch on some important dates to know, as there are some DSCSA deadlines coming up in the next few years that will further impact your pharmacy operation.