I am writing this from Mumbai India where I am scheduled to speak at the Systech Uniquity Conference, but I will be home by the time you read this. I just won’t have time to publish a new essay this week due to the incredibly long flights I need to get home. So, here is a re-posting of a great essay from May 9, 2016.
Medical convenience kits are exempt from the Drug Supply Chain Security Act (DSCSA). But be careful. Just because you and your customers have called your product “a kit” for years doesn’t mean that Congress and the FDA call it that under the DSCSA. In fact, many products that have historically been referred to as “medical convenience kits” will be treated under the DSCSA as a repackaged drug, a combination product, or worse, just a collection of device(s) and drug(s). Let’s take a closer look.
TRUE CONVENIENCE KITS ARE EXEMPT
The definition of “medical convenience kit” and their exemption from the DSCSA occurs in Section 581(24) within the definition of “Transaction”, specifically Section 581(24)(B)(xiii). The identical definition is repeated under Section 204, the “National Standards For Prescription Drug Wholesale Distributors” as one of the items in the list of things that do NOT constitute “wholesale distribution” of prescription drugs.
“(xiii) the distribution of a collection of finished medical devices, which may include a product or biological product, assembled in kit form strictly for the convenience of the purchaser or user (referred to in this clause as a `medical convenience kit’) if–
(I) the medical convenience kit is assembled in an establishment that is registered with the Food and Drug Administration as a device manufacturer in accordance with section 510(b)(2);
(II) the medical convenience kit does not contain a controlled substance that appears in a schedule contained in the Comprehensive Drug Abuse Prevention and Control Act of 1970;
(III) in the case of a medical convenience kit that includes a product, the person that manufacturers the kit–
(aa) purchased such product directly from the pharmaceutical manufacturer or from a wholesale distributor that purchased the product directly from the pharmaceutical manufacturer; and
(bb) does not alter the primary container or label of the product as purchased from the manufacturer or wholesale distributor; and
(IV) in the case of a medical convenience kit that includes a product, the product is–
(aa) an intravenous solution intended for the replenishment of fluids and electrolytes;
(bb) a product intended to maintain the equilibrium of water and minerals in the body;
(cc) a product intended for irrigation or reconstitution;
(dd) an anesthetic;
(ee) an anticoagulant;
(ff) a vasopressor; or
(gg) a sympathomimetic;”
To be considered a “medical convenience kit” and get the exemption, all of the conditions I, II, III and IV must apply to your product. For IV to apply, the prescription drug(s) contained in the kit must fall into one of the product classes listed in (aa), through (gg).
BUT YOU MIGHT BE VIEWED AS A “REPACKAGER” UNDER THE DSCSA
Clause (III)(bb) deserves closer attention. According to this clause, the kit assembler cannot alter the primary container or label that the original manufacturer provides for the prescription drug. The “primary container or label” is where the original manufacturer or repackager would have placed their DSCSA product identifier (see “The DSCSA Product Identifier On Drug Packages”) so that the product may be distributed in the supply chain. If you open that primary container to extract a unit dose or some other non-serialized sub-division of the drug to include in your kit, then you have altered the primary container, and therefore you are no longer assembling a “kit”. Instead, you are repackaging the original manufacturer’s product and you should follow the DSCSA rules for repackaging, including the need for adding a new DSCSA product identifier with your own serial number, and associating the original manufacturer’s product identifier to yours [see DSCSA Section 582(e) and “Who Is A DSCSA Repackager?”].
MAYBE YOUR KIT DOESN’T REALLY CONTAIN A TRUE DSCSA “PRODUCT”
Pay close attention to the use of the word “product” in the clause above. For the DSCSA, the term means:
“(13) Product.–The term `product’ means a prescription drug in a finished dosage form for administration to a patient without substantial further manufacturing (such as capsules, tablets, and lyophilized products before reconstitution), but for purposes of section 582, does not include blood or blood components intended for transfusion, radioactive drugs or radioactive biological products (as defined in section 600.3(ee) of title 21, Code of Federal Regulations) that are regulated by the Nuclear Regulatory Commission or by a State pursuant to an agreement with such Commission under section 274 of the Atomic Energy Act of 1954 (42 U.S.C. 2021), imaging drugs, an intravenous product described in clause (xiv), (xv), or (xvi) of paragraph (24)(B), any medical gas (as defined in section 575), homeopathic drugs marketed in accordance with applicable guidance under this Act, or a drug compounded in compliance with section 503A or 503B.”
The other components of your “kit” may be considered by the FDA as medical devices. The FDA regulates medical convenience kits that contain only medical devices as defined in 21 CFR 801.3 (see also “Unique Device Identification: Convenience Kits Draft Guidance for Industry and Food and Drug Administration Staff”). The presence of a prescription drug (a DSCSA product) is what brings the DSCSA into scope.
MAYBE YOUR KIT IS REALLY A COMBINATION PRODUCT
If you meet all of the other requirements of Section 581(24)(B)(xiii) but your “kit” contains a prescription drug that does not fit into one of the product classes called out in clause IV(aa) through IV(gg), then perhaps you are building what the FDA calls a combination product (CP) [see 21 CFR 3.2(e) and “Correction: Your Drug or Biologic Combination Product Is Probably NOT Exempt From The DQSA”]. CPs that are determined to have an overall primary mode of action (PMOA) as a drug or biologic must comply with the DSCSA as a drug and not as a kit (see “Is Your Drug Exempt From The Federal Drug Supply Chain Security Act?”). In this case, you will need to apply your own DSCSA product identifier to your package and treat it like any other drug product that cannot be sub-divided within the supply chain. For more on CPs, see “Combination Products Guidance Documents”.
If your collection of medical devices and drug(s) is not any of the things above, then it is probably just that: a collection of separately regulated products. In this case, you will need to make sure the medical devices in your collection comply with the Unique Device Identification (UDI) regulation, if necessary, and the drug product(s) comply with the DSCSA. Your packaging will need to expose the original manufacturer’s UDI label information (see “FDA Proposed UDI: AIDC Requirements”) as necessary and the DSCSA product identifiers of the drugs contained within so that downstream wholesale distributors and dispensers are able to read them and comply with these regulations as if these products were shipped separately.
One way to do that might be to make the product identifiers on the contained product visible from the outside through a clear section of packaging. If you take this approach, make sure that the required barcodes and human readable are always readable without opening the packaging of the collection (for DSCSA purposes, let’s not call it a “kit”).
You will be acting as a DSCSA wholesale distributor when you sell your collection and so you must follow the regulations contained in Section 582(c) of the DSCSA.
Companies who package medical devices with drugs for the convenience of the end user need to perform a careful analysis to figure out exactly how the resulting package will be regulated. In some cases, consulting with the FDA may be the only safe way of figuring it out.