Drug Supply Chain Integrity Act (DSCSA):
Most pharmacies in the United States are required to have systems in place to receive transaction information regarding the prescription drugs they purchase from suppliers and manufacturers starting on July 1st of this year. The federal law called the Drug Supply Chain Integrity Act (DSCSA), which is a part of the Drug Quality and Security Act passed in 2013, will then become effective and enforced by the FDA. The law was passed to increase pharmaceutical accountability and security throughout the U.S. and has been slowly implemented in phases over the past several years. Pharmacies are classified as “dispensers” by the DSCSA and are finally being required to participate in the law.
Pharmacies will be required to collect and keep records of what is being dubbed the “3T” information (Transaction History, Transaction Statement, and Transaction Information) for each prescription drug it purchases on or after July 1st. It is also important to note that covered pharmacies must also have systems in place to segregate and investigate any drugs purchased or received after the July 1st deadline. This part of the law is specifically aimed at the compounding and specialty pharmacies that have been at the center of national attention since concerns about the safety of compounding pharmacies were raised after a 2012 outbreak of fungal meningitis tied to a compounding pharmacy in Massachusetts.
Some other aspects of the DSCSA to consider include:
– When ownership of a pharmacy changes, or the prescription files are transferred to another pharmacy, the pharmacy will need to provide the 3T information to the new owner or pharmacy receiving the transferred prescription files.
– Product returns also are addressed in the DSCSA law. In this respect, pharmacies cannot view the DSCSA as only requiring the passive receipt of information from suppliers or manufacturers.
– Records and information will need to be retained for at least 6 years, so pharmacies also need to deal with this additional and significant record-keeping responsibility.
This law applies to almost every pharmacy in the country. The only exclusions are licensed health care practitioners (such as physicians) who dispense medication as part of their medical practice. Any pharmacy that has not yet begun considering the impact of the DSCSA on its business should do so immediately. Pharmacies that do not currently have systems in place to ensure compliance with the laws requirements should take steps to develop appropriate policies and procedures, train their pharmacists on the new systems, and be prepared for the July 1st deadline for receiving and providing 3T information.
HCC is here to help you prepare for the DSCSA requirements. Healthcare Consulting is a full service Pharmacy Consulting firm that has been in business for over 25 years. HCC has been helping pharmacies plan, prepare and deal with critical business issues such as new DSCSA law since 1989. HCC is owned and operated by pharmacists who are experts in the development and implementation of policies and procedures in all areas of Pharmacy practice. It is also a good opportunity for you to ensure that your pharmacy is in compliance with all state licensing requirements and to have all of your pharmacies’ policies and procedures reviewed by experts! Contact us on line or call us today for a Free Consultation at 800-642-1652 to discuss how we can help you.