Skip to content

DSCSA Compliance Deadline is Approaching: Answering your Top Questions Related to DSCSA

FDA’s DSCSA deadline is approaching quickly.

Drug manufacturers, distributors, repackers, and third-party logistics (3PL) providers are struggling to meet the requirements.

Question 1: What is DSCSA Compliance?

The Drug Quality and Security Act (DQSA) was enacted on the 27th of November 2013 by Congress.

The DSCSA i.e. Drug Supply Chain Security Act put forward new requirements and definitions for ensuring high security of drug distribution in the US pharmaceutical industry.

An interoperable system is developed by the body to trace the prescribed drugs from manufacturers to dispensers.

This system is capable of tracing drugs at individual as well as lot package levels.

An amendment to the law was made in the same year that required the companies to take specific steps for improving the traceability and safety of the prescription drug supply.

For example,

  • Manufacturers must affix a product identifier on each package that they ship
  • Repackagers must track any product changes
  • Distributors must verify the pedigree of the received products
  • Dispensers must report to FDA if any suspect product is identified

The Food and Drug Administration will do a thorough analysis along with combat drug counterfeiting.

Question 2: What was the Need for Enacting DSCSA?

The DSCSA was the response of government to the growing problems in the US Pharmaceutical supply chain such as,

  • Counterfeit drugs
  • Adultered drugs
  • Mislabeled drugs

These drugs were identified by the FDA and were restricted from entering the drug supply chain.

This act aimed to build a traceability system that can identify potentially dangerous drugs and prevent them from reaching patients.

Question 3: Which Products are Subjected to the Act?

The act applies to all the distributed and dispensed medicines in the US.

The only excepted drugs are

  • Compounded
  • Over-the-counter (OTC)
  • Veterinary

The companies need to keep records of all the transactional information related to the drugs included in the act.

  • Sales
  • Returns
  • Recalls
  • Destruction

Question 4: What is the Deadline to Meet DSCSA Requirements?

The deadline to meet the DSCSA compliance is on the 27th of November, 2023.

This deadline applies to:

  • Manufacturers
  • Repackagers
  • Wholesale distributors
  • Dispensers
  • Third-party logistics providers

Question 5: What are the DSCSA 2023 Requirements?

Interoperable electronic tracing is one of the key components of the DSCSA 2023 requirements.

2023 DSCSA requirements are composed of three specific yet highly interrelated components.

1. Interoperable Exchange

All trading partners will be required to exchange transaction information and statements.

The information should be transferred in an electronic, interoperable, and secure manner.

The package-level product identifier must be included in the information.

2. Interoperable Verification

All trading partners will be required to verify packages and sealed homogenous cases with the help of a product identifier.

3. Interoperable Tracing

All trading partners will have to provide transactional information and statements with secure, electronic, interoperable systems and processes.

The request should be responded quickly in order to facilitate information gathering for each transaction going back to the manufacturer.


Phase I requirements end on the given deadline by the FDA DSCSA including the full transaction history of the product to the manufacturer.

DSCSA is a “one up and one back” model where each trading partner has a record of the entity they are connected to.

FDA believes interoperable tracing systems and processes should be capable of providing information equivalent to unit-level transaction history.

Question 6: When Does the Transaction Statement Reporting Go into Effect?

The members of the pharmaceutical distribution supply chain are required to report their

  • State license
  • Contact information
  • Disciplinary actions (by federal or state government)
  • Translation statement

The reporting of transaction statements is the final phase which goes into effect on November 27, 2023.

Trading partners need to exchange transaction information and statements for each transfer or sale of products subjected to DSCSA.

Question 7: Is there a Solution that meets all the Healthcare Requirements?


There’s a solution that meets all the healthcare requirements.

Along with yours!

We’ve developed a pharmacy solution that is feature-rich and saves costs for your pharmacy operations.

Question 8: Is the Solution Compliant with other Healthcare Regulations like HIPAA, PHIPAA, and PIPEDA?


You don’t need to worry about compliance.

We have been dealing with healthcare regulations and compliance for 8+ years now.

The solutions that we’ve developed are in compliance with every healthcare regulation.

Question 9: What is so Special about your Solution?

Along with being in compliance with every healthcare regulation, the delivery time and pricing of our software solutions are the 2 unique things making them special.

We have worked on 60+ projects and delivered them before the deadline.

We also offer an expensive feature set in our solution.

Question 10: What Features do you Provide in your Solution?

  • Automated refill order reminders
  • Automated refills
  • Automated prescription renewal reminders
  • Integration with the PBMS and international partner software
  • Automated order placement in the international partner software
  • Automated updates of the tracking details
  • Limited medication visibility
  • Automated emails and notification alerts from your pharmacy
  • Order sets for specific requirements
  • Reports of the saved costs
  • No limitation on the number of partner pharmacies
  • Customizable discount rates for each partner pharmacy

You can even customize the software as per your unique needs!

Question 11: Who are We?

We’re a local Canadian IT company dedicated solely to the healthcare industry.

We are a team of healthcare app developers, UI/UX designers, business analysts, and compliance specialists who are some of Canada’s sharpest brains when it comes to healthcare IT.

All of us have only been working on healthcare projects since the first day of our professional careers.

We can deliver you peace of mind and reduce your stress when it comes to the business, tech, and compliance needs of your healthcare organization.