Complying with Prescription Drug FDA Requirements
Stay up to date on the latest prescription drug FDA shipping and packaging requirements and best practices for pharmacies.*
1. Only accept ownership of a prescription drug that is accompanied by Transaction Information, Transaction History, and a Transaction Statement.
The 2013 Drug Supply Chain Security Act (DSCSA) requires companies involved in dispensing drugs, referred to as Dispensers, in the drug supply chain, primarily pharmacies, to exchange product tracing information about a drug and who handled it each time it was sold in the U.S. market. Dispensers are required to capture and maintain this information.
2. Incorporate software processes and automation principles to assist with arduous drug verification requirements.
The Drug Supply Chain Security Act requires Dispensers to have established processes and systems to be able to comply with drug authenticity verification requirements. Beginning in 2020, Dispensers must also have the capability to scan a 2D barcode appearing on every serialized “authentic” drug.
3. Use CASI’s SolidSuiteRX™ pharmacy software and NGPA automation products to track details of all drug transactions following pharmacy receipt of verified drugs.
Where the DSCSA-required tracing of received drugs at the pharmacy leaves off, the CASI-provided tracking of all subsequent drug transactions and parameters starts. When you utilize the most advanced pharmacy production software on the market, the supplemental tracking extends drug tracing all the way to the end patient, allowing for cradle-to-grave drug history and extensive drug recall capability.
*The information contained herein should not be construed as legal advice. For a complete analysis of the laws applicable to your operation, please consult a licensed attorney.