DSCSA Compliance
The DSCSA was enacted in 2013 to combat counterfeit drugs and ensure integrity in the pharmaceutical supply chain.
As a pharmacist, you play a pivotal role in compliance by following guidelines for verifying the legitimacy of drugs, tracking their movement, and maintaining proper documentation.
Non-compliance with DSCSA can result in penalties and affect the safety of your patients.
Overview of DSCSA Compliance
- The DSCSA was enacted in 2013 to combat counterfeit drugs and ensure integrity in the pharmaceutical supply chain.
- As a pharmacist, you play a pivotal role in compliance by following guidelines for verifying the legitimacy of drugs, tracking their movement, and maintaining proper documentation.
- Non-compliance with DSCSA can result in penalties and affect the safety of your patients.
What is DSCSA?
- The Drug Supply Chain Security Act (DSCSA) is part of the FDA’s effort to enhance the safety and security of the pharmaceutical supply chain.
- DSCSA outlines requirements for tracking and tracing prescription drugs in the United States.
Pharmacists’ Role
- Pharmacists are integral in ensuring that drugs are safe and traceable from manufacturer to patient.
- Key responsibilities include verification, record-keeping, and managing suspect and illegitimate products.
Importance of Compliance
- Ensures patient safety and reduces the risk of counterfeit and stolen drugs entering the supply chain.
Key Requirements for Pharmacists
- One of your key duties under DSCSA is to verify the drug’s legitimacy before dispensing it to patients. This means cross-checking product information and using your pharmacy’s electronic system to ensure compliance.
- You must keep a detailed transaction history, which includes details on the drug’s journey from the manufacturer to the distributor and ultimately to your pharmacy.
- If you identify a suspect drug, you have the responsibility to manage it appropriately and report it to the relevant authorities.
Verification of Drug Information
- Pharmacists must verify the lot number, expiration date, and serial number of each drug received.
- Utilize electronic systems to confirm product legitimacy.
Transaction History (TH), Information (TI), and Statements (TS)
- Keep a secure and accessible record of all transactions from the manufacturer to the dispenser.
Handling Suspect or Illegitimate Drugs
- Notify the FDA and the manufacturer immediately if a drug is identified as suspect or illegitimate.
- Quarantine suspect products until their status is verified.
DSCSA Compliance Steps for Pharmacies
- Pharmacies are required to have systems in place to track drugs from the point of manufacture to the final sale or dispensation
- Record-keeping is essential to ensure compliance with DSCSA, so maintaining complete and accurate logs will help during audits and inspections.
- In addition to electronic systems, ensure your physical security measures are robust to protect drugs from theft or tampering.
Recordkeeping
- Maintain accurate records for six years for each drug transaction.
- Store records in a secure manner for easy retrieval during inspections.
Tracking and Tracing
- Pharmacies must maintain an unbroken chain of custody for every drug dispensed.
- Electronic tracking systems must be used for serial number verification.
Security Measures
- Ensure your pharmacy’s security procedures prevent unauthorized access to drugs.
- Implement physical and electronic safeguards.
Challenges of DSCSA Compliance
- One of the biggest challenges is keeping up with the evolving technology requirements under DSCSA. Staying current with software upgrades and system interoperability is key.
- Staff training is another area where many pharmacies struggle. Regular education will ensure that your team understands how to handle suspect products and follow correct procedures.
- Determining if a drug is counterfeit or suspicious can take time, so it’s important to establish clear lines of communication with manufacturers and regulatory bodies to ensure rapid resolution.
Technology Integration
- Implementing and maintaining electronic tracking systems can be costly and complex.
- Ensuring that your software is up-to-date and compatible with industry standards is crucial.
Training and Education
- Regular staff training on DSCSA protocols is necessary to ensure compliance across all pharmacy personnel.
Managing Suspect Products
- Determining whether a drug is illegitimate can be challenging and requires coordination with manufacturers and law enforcement.
Partner with Advasur for a streamlined path to compliance.
Advasur 360 Compliance Services is a comprehensive suite of Drug Supply Chain Security Act (DSCSA) services that will help you with all current and future DSCSA requirements.