After November 27, 2017 the U.S. Drug Supply Chain Security Act (DSCSA) requires drug manufacturers (2018 for repackagers) to affix a DSCSA “product identifier” to all drug packages entering the supply chain (see “The DSCSA Product Identifier On Drug Packages”). According to the DSCSA, that product identifier must be present in both human-readable and 2D Data Matrix barcode forms. Part of that product identifier is what is known as a Standardized Numerical Identifier (SNI). The SNI is composed of the drug’s National Drug Code (NDC) and a serial number (see “DSCSA ‘Serial Numbers’”) that is unique on every individual package of that drug (see “FDA Aligns with GS1 SGTIN For SNDC” and “Anatomy Of An FDA SNI”).
Lately, I’ve heard people in the industry claim that it is acceptable to use a GS1 Global Trade Item Number (GTIN) that encapsulates an NDC (see “Depicting An NDC Within A GTIN”) to satisfy the NDC part of this DSCSA requirement to affix the product identifier on a drug package. I’m not so sure about that. Let me explain.
THE NDC ON DRUG PACKAGES
The regulations surrounding the definition of the NDC and how it must appear on drug labels is contained in the U.S. Code of Federal Regulations (CFR) 21 Part 207.35, “Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution”. In this regulation, the NDC is clearly defined as a 10-character (“numerals only”) code. There was only one thing that surprised me. It says that the Labeler Code is a five digit code, but then it says, “FDA will expand the Labeler Code from five to six numeric characters when the available five-character code combinations are exhausted.”
OMG! If they ever do that, that would make the NDC an 11-digit code—an 11-digit code that would then be distinctly different from the 11-digit reimbursement code that dispensers and PBMs created that is based on the 10-digit NDC! That would force the dispensers and PBMs to extend their reimbursement code (unfortunately they call it “an NDC”) to 12-digits! That would really make a mess, making the case even stronger for dumping the whole NDC system in favor of just using GS1 GTINs for drug identification—the case I made in my recent open letter to the FDA (see “An Open Letter To The FDA, RE: Please Fix The National Drug Code Soon”).
But let’s set that future catastrophe aside for now. Regarding the presentation of the NDC on drug packages, Section 207.35(b)(3) of the code says:
(IMPORTANT NOTE: In September 2018 I discovered that the following extract is no longer valid. At some point between the original publication of this essay and that date, FDA removed much of the text in the extract below, and has redefined the NDC as a 10 or 11 digit code. This removal does not invalidate points made in this essay, although the reader should be careful about applying anything from the obsolete extract below. I’m leaving it here for historical reference purposes because it was valid when I wrote this essay. The fact that FDA has removed it is probably related to the DSCSA requirements mandating the new product identifier (which is NOT optional) and the SNI guidance. –Dirk.)
“(3) FDA requests but does not require that the NDC number appear on all drug labels and in other drug labeling, including the label of any prescription drug container furnished to a consumer. If the NDC number is shown on a drug label, it shall be placed as follows:
(i) The NDC number shall appear prominently in the top third of the principal display panel of the label on the immediate container and of any outside container or wrapper. Instead of appearing in the top third of the label, the NDC number may appear as part of and contiguous to any bar-code symbol for any drug product if two conditions are met. First, the symbol appears prominently on the immediate container and on any outside container or wrapper and in a conspicuous location; this condition is not satisfied by the appearance of the symbol only on the natural bottom of a container or wrapper. Second, the bar-code symbol is compatible with the NDC, i.e., the symbol provides a format capable of encoding the numeric characters of an NDC Number. The term principal display panel, as used in this paragraph, means that part of a label most likely to be displayed, presented, shown, or examined under customary conditions of display to the consumer (for over-the-counter drug products) or to the dispenser (for prescription drug products).
(ii) The NDC number shall be preceded by the prefix “NDC” or “N” when it is used on a label or in labeling. The prefix used for a drug product shall be used consistently on the label of the immediate container, outside container, or wrapper, if any, and on other labeling for that drug product.
(iii) The Product-Package Code configuration shall be indicated and the segments of the number shall be separated by a dash, e.g., NDC 15643-542-12 or N 15643-542-12.
(iv) All 10 characters shall appear and the leading zeros in any segment of the NDC number shall be shown, except that leading zeros may be omitted from any segment of the NDC number when the NDC number is used for product identification by direct imprinting on dosage forms or in the case of containers too small or otherwise unable to accommodate a label with sufficient space to bear both required and optional labeling information.
(v) The placing of the assigned NDC number on a label or in other labeling does not require the submission of a supplemental new drug application, supplemental new animal drug application, or a modification to an index listing.”
That appears to say that placing the NDC on prescription drug labels is optional, although that specific word is not used. Because it is within the CFR, this is binding regulation. Three years ago, the FDA published additional non-binding, draft guidance related to drug container labels called “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors”. This document at least confirms that the NDC is “…a unique 10-digit, 3-segment number…” (see section IV.G). This document also provides some useful guidance for the barcode.
“A bar code should be placed on the immediate container label and carton labeling of most drug products. The barcode should be surrounded by enough white space to allow scanners to read the bar code properly (see 21 CFR 201.25(c)(2)). Print density should be consistent to allow for an accurate scan. The bar code should be placed in a conspicuous location (e.g., not on the bottom of a carton) where it will not be difficult to read because of distorted text. Additionally, the barcode should be placed in an area where it will not be damaged because it appears at the point of label separation (e.g., perforation).”
Oddly this guidance does not mention what the contents of the barcode should be. Prior to the passage of the DSCSA, the contents was the NDC of the drug package. This is confirmed by 21 CFR 201.25, Bar Code Label Requirements, which was added in 2004 by what is commonly known as the FDA Linear Barcode Rule. 21 CFR Section 201.25(c) says the barcode must contain:
“…at a minimum, the appropriate National Drug Code (NDC) number in a linear bar code that meets European Article Number/Uniform Code Council (EAN.UCC) or Health Industry Business Communications Council (HIBCC) standards.”
The European Article Number/Uniform Code Council (EAN.UCC) organization referred to in this code changed its name shortly after this code was written. Their new name? GS1.
So there you go. For the linear barcode that must appear on all prescription drug packages, you must follow either GS1 or HIBCC standards. In my entire career, I have only seen a single prescription drug package that used a HIBCC standard to format the NDC barcode and that was quite a few years ago, so the vast majority of companies have chosen GS1 standards, for whatever reason (see “Will Use Of EPCIS Force Everyone To Use GS1 Identifiers?”).
So the human-readable NDC on the label of a prescription drug is apparently optional, but the NDC in barcode form is required! That is the situation until November 27, 2017. On that date, the DSCSA results in a few changes. We will take a look at how things change in 2017 in the next essay in this series, and we will finally be able to answer the question posed in the title. Stay tuned.