Tag: Food and Drug Administration (FDA)

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 referred to as the Drug Supply Chain Security Act provisions. This Act enhanced the FDA’s ability to protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful from being dispensed and administered to patients by requiring certain product tracing information be provided and maintained by certain dispensers. The guidance is intended to describe the FDA’s current thinking on the topic and should only be viewed as recommendations, unless a specific regulatory or statutory requirement is cited.

Background

The Drug Supply Chain Security Act requires that dispensers (retail and hospital pharmacies), trading partners (manufacturers, re-packager, wholesale distributor), and third party logistics providers (entities that provides or coordinates warehousing but doesn’t take ownership) to provide and maintain tracing information to entities upon distribution or transfer of ownership and that both dispensers and those who receiving ownership of a product had to maintain the tracing information for a minimum of six (6) years.

The tracing information includes both a transaction report and transaction statement.  The information required in those reports are defined in Section 581 of the Act and include:

Transaction Report

  • Proprietary or established name or names of the product
  • Strength and dosage form of the product
  • National Drug Code number of the product
  • Container size
  • Number of containers
  • Lot number of the product
  • Date of the transaction
  • Date of the shipment, if more than 24 hours after
  • Date of the transaction
  • Business name and address of the person from whom ownership is being transferred

Transaction Statement

  • Is authorized as required under the Drug Supply Chain
  • Received the product from a person that is authorized as required under the Drug Supply Chain Security Act
  • Received transaction information and a transaction statement from the prior owner of the product, as required under section 582
  • Did not knowingly ship a suspect or illegitimate product;
  • Had systems and processes in place to comply with verification requirements under section 582
  • Did not knowingly provide false transaction information; and
  • Did not knowingly alter the transaction history.

The administrative requirements of these provisions have been a compliance challenge for many EMS agencies who often lack the resources to maintain this information in paper or electronic form for a minimum of six years.

Another requirement of the Act is that dispenser can only distribute medications to “authorized” entities who are licensed in the state to which they dispensing the product.  This is often a challenge because some EMS agencies do not meet the definition of “authorized” under the Act.

New Guidance

This new guidance was issued to minimize the possibility of disruptions to first responders due to the provisions of the Act. In issuing this guidance, the FDA states that it recognizes that dispensers, such as hospital pharmacies, often dispense small quantities of medications periodically and that many dispensers (pharmacies) lack the resources to provide product tracing information for these transactions.  Also, the FDA recognizes that many first responders do not meet the definition of “authorized” dispensers as delineated in section 581(2) of the Act but are authorized under applicable law to administer medications without a license by medical treatment protocols or standards.  The guidance states that the FDA does not intend to take action against with regard to the following provisions of the requirements for transactions with first responders.

Trading Partners

The FDA is not intending to take action against a dispenser who transfers ownership of product directly to a first responder when the dispenser does not provide the first responder with product tracing information provided that:

  • The dispenser captures and maintains the product tracing information for the transaction for not less than six (6) years after the transaction; and
  • The dispenser provides such product tracing information to the first responder or the FDA if requested not later than two (2) days after receiving the request.

The FDA also does not intend to take action against a trading partner (dispenser) who transfers product to a first responder who is not “authorized” as a dispenser within the meaning of the Act.

First Responders

The FDA is not intending to take action against first responders who:

  • Accept ownership of a product without first receiving the product tracing information and does not keep and maintain that information for six (6) years.; or
  • Does not have systems in place to enable the verification of suspect and illegitimate product as required by section 582(d)(4).

However, first responders who suspect that the product that they received is illegitimate, the FDA recommends that the first responder take steps to protect patients from receiving such product and should notify the authorities.

Bottom Line

This guidance should remove much of the administrative roadblocks for those who dispense medications to first responders.  It should also remove the administrative burdens for services who do not have the resources or infrastructure to comply.  That being said, if you are currently meeting these requirements, I would suggest that you continue to do so.  However, if these sections of the Section 582 provisions were preventing your services from getting medications from dispensers, this should provide some relief.  As always, if you have any questions or need further clarification, please contact the American Ambulance Association.

FDA Issues First Responder Drug Dispenser Guidance

In accordance with the Drug Supply Chain Security Act of 2013, the FDA issued regulations last year to require drug dispensaries to build an electronic system to identify and track the distribution of drugs. Many small dispensaries do not have the ability currently to electronically trace small quantities of drugs. The AAA became concerned that hospital and other small dispensers would no longer provide first responders with critical drugs in fear of not being compliant with the new regulations. The AAA joined a coalition of dispensaries, pharmacists and others that also had concerns with the new regulations.

As a result of the efforts of the coalition and the AAA, we were able to delay enforcement of the requirements until today, March 1. The AAA then worked directly with the FDA to educate them about the unique nature that small dispensaries sometimes play in restocking certain ambulance service providers. Upon learning of these transactions, the FDA shared our concerns and worked quickly to release the guidance.

The guidance states that the FDA will not take action against drug dispensaries in providing drugs to first responders if the dispensary follows certain basic recording keeping policies. The agency will also not take any action against the first responder. The guidance is entitled “Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act — Compliance Policy Guidance for Industry“.

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.