The US Food and Drug Administration (FDA) on Tuesday released new draft guidance to help trading partners in the pharmaceutical supply chain request waivers or exemptions from requirements in the Drug Supply Chain Security Act
(DSCSA) of 2013.
The DSCSA, which outlines the steps to build a system by 2023 to identify and trace pharmaceuticals as they are distributed in the US, establishes a process by which an authorized manufacturer, repackager, wholesale distributor or dispenser may request a waiver from any of the requirements of the law.
The law says the HHS secretary may grant such waivers or exemptions from certain DSCSA requirements if they “would result in an undue economic hardship or for emergency medical reasons, including a public health emergency declaration pursuant to section 319 of the Public Health Service Act.”
Dirk Rodgers, regulatory strategist for Systech International, which focuses on health care supply chains, told Focus
that prior to the draft’s release, FDA senior adviser Connie Jung told him at a conference last May that companies which felt they needed a waiver could simply send an email to their DSCSA email address. He said he heard at least one person say they had sent a waiver request but did not receive a response.
As far as enforcement of DSCSA requirements, Rodgers said: “I don’t know what to expect in terms of enforcement. We will certainly not see a brigade of FDA agents flooding drug manufacturers to check up on their compliance, but some people think FDA inspectors will start asking questions when they are onsite at drug manufacturers to gauge their progress toward compliance. My point is that the timing of this publication is important to their ability to begin enforcement in November.”
In June, FDA said in another draft guidance
that it does not intend to take action against manufacturers that do not affix or imprint a product identifier to each package and homogenous case of products intended to be introduced in a transaction into commerce before 26 November 2018.
Draft Guidance on Waivers
In addition to explaining what each waiver, exception or exemption request to FDA should include, the draft explains how, if FDA determines that a request lacks sufficient information to permit a substantive review, the agency may deny the request.
“FDA may also contact a requesting trading partner or stakeholder to clarify an aspect of the request (e.g., the products covered by the request) or to ask for additional information related to the subject of the request,” the draft says. “During the review, FDA intends to consult with subject matter experts within the Agency as appropriate and assess, as applicable, whether: A waiver of the section 582 requirement(s) identified in the request is (1) warranted because complying with the requirement(s) would result in undue economic hardship or (2) appropriate for emergency medical reasons.”
The agency will also determine whether an exception to the DSCSA requirements “relating to product identifiers is warranted because the product identified in the request is packaged in a container that is too small or otherwise unable to accommodate a label with sufficient space to bear the information required for compliance with these requirements.”
FDA also says it would look into if exempting “the product(s) and/or transaction(s) identified in the request from the section 582 requirement(s) identified in the request is appropriate to maintain public health or is otherwise appropriate.”
The draft also says that FDA intends to notify the requesting trading partner or stakeholder of a waiver, exception or exemption request in writing of the determination to grant, deny or take other appropriate action on a request, and explain the basis of the determination. FDA also said it may post information regarding a determination to its website if doing so is in the best interest of, or is necessary to protect, public health.
“Such information would be posted in a manner that is consistent with the laws and regulations regarding the disclosure of confidential information,” the draft says.
Once every two years, FDA also said it intends to review waivers, exceptions and exemptions that are valid until further notice or if the expiration date is more than two years after the effective date, and renew such waivers, exceptions and exemptions, as applicable.
FDA also said companies should be forthcoming if situations change that could affect the product identifier.
The agency offered the hypothetical example of how if a manufacturer receives an exception for a product packaged in a container that is too small to accommodate a label with a product identifier and the exception has an effective period of three years.
If, a year after receiving the exception, the manufacturer begins packaging the product in a larger container that is able to accommodate a product identifier, the draft says that the “manufacturer should notify FDA of this change when it begins production with the new container instead of waiting until the biennial review of the exception.”
In addition, when finalized, this draft guidance will describe how FDA intends to biennially review and renew waivers, exceptions and exemptions, the agency said.
FDA estimates that annually, a total of approximately 20 waiver, exception, or exemption requests will be submitted to it by approximately 20 trading partners or stakeholders.
Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry