The Drug Supply Chain Security Act (DSCSA) is a federal law that was enacted in 2013 to protect the public from counterfeit, contaminated, and other potentially dangerous drugs in the pharmaceutical supply chain. The DSCSA requires pharmaceutical companies to implement enhanced security measures and traceability systems to ensure the authenticity and safety of prescription drugs. As part of this effort, the law requires Pharmacies or dispensers, as Pharmacies are referred to under DSCSA, to comply with certain requirements.

Unfortunately, there are many myths and misconceptions surrounding the requirements of Pharmacies when it comes to DSCSA compliance. Here are the top five. We saved the two most potential costly ones for last.

Myth #1: DSCSA Compliance is Not Necessary

One of the most common myths about DSCSA compliance is that it is not necessary. This is simply not true. Compliance with the DSCSA can help to ensure the safety and authenticity of the medications being dispensed, which is essential for protecting the health and well-being of the public. To meet this goal, the DSCSA requires Pharmacies to meet certain compliance requirements, specifically related to authorized trading partners, product identifiers, product training, and verification now. Pharmacy must also be compliant with the Electronic Drug Distribution Security (EDDS) requirements of DSCSA by by November 27, 2023.

Myth #2: DSCSA Compliance is Too Costly

Another common myth about DSCSA compliance is that it is too costly for Pharmacies to comply. While it is true that there are costs associated with DSCSA compliance, such as the cost of purchasing and implementing new technologies and/or systems, these costs are far outweighed by the benefits of compliance. Depending on how you decide to comply, the cost can also vary greatly.  If you build your own solution, the development and maintenance costs can be extreme.  But if you use a turnkey system like DSCSA 360TM, you are provided with the software, SOPs, Training, and subject matter experts at a much lower cost.

Myth #3: DSCSA Compliance is Too Complicated

Another myth about DSCSA compliance is that it is too complicated for Pharmacies to understand and implement. While it is true that the DSCSA does require Pharmacies to meet certain requirements, these requirements are not overly complicated. In fact, there are many resources available to help Pharmacies understand and comply with the DSCSA, such as DSCSA 360TM.

Myth #4: DSCSA Compliance is Unnecessary for Smaller Pharmacies Since They Will Not Be Inspected

This myth could not be more wrong. Complying with the DSCSA is mandatory and to ensure enforcement, the FDA has implemented a new desktop monitoring program that allows them to do thousands of DSCSA compliance audits quickly and efficiently. Failure to comply with DSCSA can lead to fines, suspension or revocation of license, and even potential imprisonment or civil penalties. Additionally, PBM’s will also monitor DSCSA compliance to justify additional claw backs – shocker!

Myth #5: My Primary Wholesaler Will Take Care of DSCSA Compliance Requirements for Me

This is the most dangerous DSCSA myth Pharmacy owners have, and it could not be further from the truth. If you believe this myth, you are in for a not-so-pleasant surprise. Why? The short answer; there are things a Pharmacy must do to comply with DSCSA that the wholesaler simply cannot provide or do for them.

Let us look at some of the DSCSA requirements a wholesaler CANNOT help a Pharmacy to meet in more detail and you can decide if you are prepared to do these yourself:

  1. They will not acquire or maintain the Pharmacy’s Global Location Number (GLN). A GLN is a business’ unique identifier used by trading partners to gather location information and master data.
  2. They will not conduct verification of the product identifier.
  3. They cannot conduct product inspections/investigations or quarantine product for you.
  4. They are not able to create or advise you on the drafting and execution of your own standard operating procedures, which must address each DSCSA requirement and be updated periodically as regulations change. More importantly, there is no associated employee training and tracking on DSCSA Compliance.
  5. Wholesalers are not permitted to assume your responsibility, respond on your behalf or to provide data in response to requests from FDA or other appropriate government authorities for the transaction data (TI/TH/TS) you receive.
  6. In accordance with DSCSA requirements, wholesalers cannot respond on your behalf to requests from Authorized Trade Partners for information necessary to facilitate the gathering of TI you may have received for a transaction.
  7. If you have more than one supplier, which most Pharmacies do, nothing the wholesaler does can assist you with meeting DSCSA requirements for those suppliers. They are prohibited from collecting or seeing the data of other suppliers for obvious reasons. Additionally, you will need to authenticate the licensure and certification of every supplier you use and be prepared to produce a current copy of those licenses and certifications, not just their respective numbers.

In conclusion, there are many myths and misconceptions surrounding the requirements of DSCSA Pharmacy Compliance. It is important for Pharmacies to understand the truth behind these myths in order to ensure that they are complying with the DSCSA. Compliance with the DSCSA is essential for protecting the health and well-being of the public, as well as for reducing the risk of civil and criminal penalties.

DSCSA 360TM from PRS and Advasur 360®  from Advasur together address every requirement Pharmacies must comply with, including everything the wholesaler cannot do for you, using a fully automated, interactive system. In fact, the program is so automated and efficient that the FDA used the Advasur 360® Program to conduct the two small Pharmacy studies mandated by the Act to ensure the small Pharmacies could comply. The studies also demonstrated it took ten minutes per week to document compliance using the Program. Thus, the Program easily pays for itself in staff time saved.”

About PRS Pharmacy Services

Founded in 1982, PRS is nationally recognized as the trusted, go-to Pharmacy consulting, brokerage and compliance/credentialing company for Pharmacy executives, owners and other professionals. Its comprehensive ComplianceTrack Platform provides a variety of Compliance Services, including DSCSA Compliance Services in partnership with Advasur, to thousands of Pharmacies in all 50 states and U.S. territories. PRS and Advasur have developed the only comprehensive Pharmacy Drug Supply Chain Security Act (DSCSA) Turn-Key Outsourced Compliance system for Pharmacy clients. This leading-edge technology platform is the most complete state-of-the-art patent-protected service and solutions in the industry. Over 5000 current Pharmacy Clients have a 100% success rate in passing Federal and State Inspections using these DSCSA Compliance Services. For more information, visit PRSrx.com.