Congress set the calendar for many different kinds of requirements when it adopted the Drug Supply Chain Security Act, signed by the President back on November 27, 2013. One of those dates was last November 27, 2015, two years after enactment, when the FDA was required to publish four new draft guidances. So far, none of them have appeared (see “FDA DSCSA Deadline Passes Quietly”).
DSCSA deadlines are usually designed to ensure that things happen in a steady progression toward a kind of full track and trace in November of 2023 and FDA guidance is critical for companies to know how the FDA interprets various parts of the law. So by missing their deadline, who is being harmed, and will that harm result in their own missed deadlines in the future?
Let’s take a closer look at what these missing documents are and who might need them right now.
- Regulations establishing standards for licensing of third-party logistics providers [DSCSA Section 584(d)(1)]
That section reads:
“IN GENERAL.—Not later than 2 years after the date of enactment of the Drug Supply Chain Security Act, the Secretary shall issue regulations regarding the standards for licensing under subsection (a), including the revocation and reissuance of such license, to third-party logistics providers under this section.”
The sections that follow include quite a few details about how this licensing program is intended to work, plus instructions on collecting comments on the proposed regulation.
Fortunately, third-party logistics providers are not harmed by the delay in the publication of this draft guidance because their deadline for compliance with it will not be set until the final guidance is published. They will have one year after that to comply. In fact, until that time, the DSCSA considers third-party logistics providers to be “licensed”. Here is Section 582(a)(7)
“THIRD-PARTY LOGISTICS PROVIDER LICENSES.—Until the effective date of the third-party logistics provider licensing regulations under section 584, a third-party logistics provider shall be considered ‘licensed’ under section 581(9)(B) unless the Secretary has made a finding that the third-party logistics provider does not utilize good handling and distribution practices and publishes notice thereof.”
So from a third-party logistics provider perspective, the longer the FDA takes to publish, the longer they are granted a free license to operate under the DSCSA.
- Regulations establishing standards for licensing of wholesale drug distributors [DSCSA Section 583(a)]
The situation is similar for wholesale distributors regarding this missing document. Section 583(a)
“IN GENERAL.—The Secretary shall, not later than 2 years after the date of enactment of the Drug Supply Chain Security Act, establish by regulation standards for the licensing of persons under section 503(e)(1) (as amended by the Drug Supply Chain Security Act), including the revocation, reissuance, and renewal of such license.”
The sections that follow include even more details about how this licensing program is intended to work, plus instructions on collecting comments on the proposed regulation.
Fortunately, wholesale distributors are not harmed by the delay in the publication of this draft guidance because their deadline for compliance with it will not be set until the final guidance is published. They will have two years after that to comply. In fact, until that time, the DSCSA considers wholesale distributors to be “licensed” as long as they hold a valid state license. Here is Section 582(a)(6):
“WHOLESALE DISTRIBUTOR LICENSES.—Notwithstanding section 581(9)(A), until the effective date of the wholesale distributor licensing regulations under section 583, the term ‘licensed’ or ‘authorized’, as it relates to a wholesale distributor with respect to prescription drugs, shall mean a wholesale distributor with a valid license under State law. “
- Guidelines on processes for waivers, exceptions and exemptions to the DSCSA [DSCSA Section 582(a)(3)]
The meat of this section is:
“IN GENERAL.—Not later than 2 years after the date of enactment of the Drug Supply Chain Security Act, the Secretary shall, by guidance—
“(i) establish a process by which an authorized manufacturer, repackager, wholesale distributor, or dispenser may request a waiver from any of the requirements set forth in this section, which the Secretary may grant if the Secretary determines that such requirements would result in an undue economic hard-ship or for emergency medical reasons, including a public health emergency declaration pursuant to section 319 of the Public Health Service Act;
“(ii) establish a process by which the Secretary determines exceptions, and a process through which a manufacturer or repackager may request such an exception, to the requirements relating to product identifiers if a product is packaged in a container too small or otherwise unable to accommodate a label with sufficient space to bear the information required for compliance with this section; and
“(iii) establish a process by which the Secretary may determine other products or transactions that shall be exempt from the requirements of this section. …”
The section that follows this one requires the FDA to include a process for biennial review and renewal of such waivers exceptions and exemptions.
Companies are not harmed by the delay in the publication of this guidance because, according to Section 582(a)(3)(C), the FDA will be able to provide a start date for the application process for these waivers, exceptions and exemptions that is not later than about May 27, 2017, which is about 180 days before manufacturers must begin applying the DSCSA Product Identifier on their products. From what I can tell, the DSCSA does not specifically require the FDA to first publish a draft, gather public comments, and then publish a final guidance for this program, but they probably will anyway because they have the time.
- Final guidance on grandfathering product [DSCSA Section 582(a)(5)(A)]
So how about grandfathering? This section says:
“PRODUCT IDENTIFIER.—Not later than 2 years after the date of enactment of the Drug Supply Chain Security Act, the Secretary shall finalize guidance specifying whether and under what circumstances product that is not labeled with a product identifier and that is in the pharmaceutical distribution supply chain at the time of the effective date of the requirements of this section shall be exempted from the requirements of this section.”
Of these four overdue guidances, this is the one I am the most eager to read. There is a very interesting issue that surround whether or not the phrase “…in the pharmaceutical distribution supply chain…” includes drug packages that are sitting in the inventories of drug manufacturers and their 3PLs. For a complete explanation, see my essay from last September, “Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL?”. This guidance should tell us how the FDA interprets this phrase and that will trigger the choice of a couple different serialization strategies for manufacturers.
This could blow the lid off of the already tight schedules of some companies by moving up their effective serialization deadline, or it could relax them. For that reason, the longer this guidance is delayed, the shorter the time companies will have to react and adjust their serialization strategies. A significant delay could cause harm and could justify calls for shifting the November 2017 serialization deadline by an equal amount to give companies time to make that adjustment, depending on which way they go.
So for three out of the four overdue guidances, the delay is not really a big deal. In fact, these guidances could be pretty complex and so it makes sense that the FDA is taking the time necessary to mak sure they get it right the first time. How big a deal the delay of the fourth guidance turns out to be will depend on the FDA’s interpretation of the DSCSA. I can’t wait to dig into it, can you?