Tag: Drug Supply Chain Security Act of 2013

Drug Supply Chain Security Act Guidance

The U.S. Department of Health and Human Services, Food and Drug Administration (FDA) recently issued guidance for the Requirements for Transactions with First Responders under Section 582 of the Food, Drug, and Cosmetic Act. For those of you who are not as familiar with this law, this is the section of the Act that is…

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AAA Meets with FDA on New Drug Dispenser Regulations

On October 21, the AAA participated in a meeting with stakeholders and the Food and Drug Administration (FDA) about the need to ensure new regulations don’t discourage the transfer of small quantities of drugs between dispensers, hospitals and first responders among others. Under the Drug Supply Chain Security Act of 2013, starting on November 1, drug dispensers must provide a full transaction history for transactions involving even small transfers of drugs. Since these transactions are often done in paper form, it will be difficult for many drug dispensers to be compliant with the new regulation and may opt to not distribute drugs in small quantities.

The AAA is participating in a coalition to ease initial enforcement on small transactions to help ensure those hospital pharmacies that provide first responders with drugs under a safe harbor agreement or direct cost reimbursement will continue to do so. The coalition of stakeholders including the AAA had sent a letter to the FDA on September 24 requesting the meeting.