Regulatory Focus™ > News Articles > New FDA Guidance for First Responders as Track-and-Trace Requirements Take Effect

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Posted 29 February 2016 | By Zachary Brennan 

New FDA Guidance for First Responders as Track-and-Trace Requirements Take Effect


Beginning Tuesday, the delayed implementation of product tracing requirements for pharmacies will take effect, and the US Food and Drug Administration (FDA) on Monday issued final guidance saying it will not take action against first responders who fail to obtain tracing information.


On 27 November 2013, the Drug Supply Chain Security Act (DSCSA) was signed into law, putting forth new definitions and requirements related to pharmaceutical product tracking and tracing.

The DSCSA will eventually help to build an electronic, interoperable system, expected by 27 November 2023, to identify and trace certain prescription drugs as they are distributed within the US to help protect patients from supply chain issues.

On 1 March, lot-level product tracing (ie. providing transaction information, history and statement) takes effect for dispensers, which are primarily pharmacies, after multiple extensions on that deadline as pharmacies have had issues meeting the new requirements.

New Guidance

Consistent with that deadline, FDA on Monday put out final guidance that says the agency will not take action against certain trading partners and first responders in order to minimize possible disruptions to distributing pharmaceuticals at the emergency response level. The new compliance policy is in effect until further notice by FDA, the agency says.

“FDA does not intend to take action against a dispenser who transfers ownership of product directly to a first responder where the dispenser does not provide the first responder with product tracing information,” the agency said.

This new compliance policy does not extend to the requirements that manufacturers, wholesale distributors and repackagers provide product tracing information to dispensers. In addition, this compliance policy does not extend to transactions in which dispensers must provide the subsequent owner with product tracing information, including transaction history.

“If a dispenser has not received product tracing information prior to or at the time it takes ownership of a product, FDA recommends that the dispenser work with the previous owner to receive this information,” the agency said. “FDA believes that product tracing information serves as an important tool for dispensers to meet their obligation … to identify suspect product, quarantine the product, and investigate whether that product is illegitimate.”

The American Society of Health-System Pharmacists (ASHP), which e

arlier in February, sent a letter to FDA, raised several compliance questions about the interpretation of the DSCSA.

In that letter, ASHP raised the issue of first responders “to ensure that the need to supply first responders is not inadvertently mixed in with other non-emergent ambulance providers. This would include the need to supply first responders with naloxone in the states and jurisdictions where it is being approved.”

ASHP also raised questions about several areas where it’s seeking additional guidance, including with investigational drug services (IDS), state-run vaccine programs, local- and state-managed disaster medication programs (i.e., atropine and 2-PAM autoinjectors), exemptions of certain intravenous fluids and the FDA’s expectations and/or communications with state boards of pharmacy regarding their plans for enforcement of the Drug Quality and Security Act (DQSA).

Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act — Compliance Policy Guidance for Industry


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