Drug Supply Chain Data Requires Lot Number and NDC
Federal and State Standards require that the supply chain tracking of drugs and the documentation of the administration of prescription drugs requires that prescription drug supply chain data be included in shipped drugs, and documented in electronic health record and immunization information systems as well as Vaccine Information Statements. This is essential for both patient safety and determining accurately what drug was provided and billed for.
The CDC, National Childhood Vaccine Injury Act, enacted in 1986, requires that Healthcare Providers Document Lot Number, Manufacturer.
Prescription Drug Supply Chain Data should include the lot number (a.k.a., batch number or code number) and classified by the NDC code.

According to CDC and the Immunization Action Coalition, “Federal requirements for documenting the vaccines administered to your patients require several data elements. The requirements are defined in the National Childhood Vaccine Injury Act (42 U.S.C. §300aa-26).[i], [ii] The law applies to all routinely recommended childhood vaccines, regardless of the age of the patient receiving the vaccines. The only vaccines not included in this law are pneumococcal polysaccharide, zoster, and certain infrequently used vaccines, such as rabies and Japanese encephalitis.
The following information must be documented on the patient’s paper or electronic medical record or on a permanent office log:
- The vaccine manufacturer.
- The lot number of the vaccine.
- The date the vaccine is administered.
- The name, office address, and title of the healthcare provider administering the vaccine.
- The Vaccine Information Statement (VIS) edition date is located in the lower right corner on the back of the VIS. When administering combination vaccines, all applicable VISs should be given, and the individual VIS edition dates recorded.
- The date the VIS is given to the patient, parent, or guardian.
The federally required information should be both permanent and accessible.”
Data Capture, Storage, and Standards Require Lot number and NDC Code in Health IT Systems and When Reporting Temperature Excursions
Lot Number is a Unique Number for Each Batch of the Product (see NDC Product Code)
A lot number is a unique number given to each batch of a manufactured product (see NDC product code below). It is also called a “lot code,” “batch number,” or “code number.” The FDA does not assign it; the manufacturer assigns it for tracking purposes to identify products that were made at the same time if there is ever a Drug Recall of the product. However, FDA does require a lot number for production and control procedures. [iii] Sometimes, drug recalls are only for affected batches, and FDA will report specific lot numbers.[iv],[v]
Lot numbers can be a combination of letters or numbers, and because the manufacturer assigns them, they have no pre-specified length and are commonly found near the expiration date. For example:
CVX and NDC codes are required and accepted according to federal agencies
National Drug Code (NDC) is a numeric code under 21 CFR 207.33. Each finished drug product or unfinished drug subject to the listing requirements of part 207 must have a unique NDC to identify its labeler, product, and package size and type.
CVX (clinical vaccines administered) and NDC are widely accepted and federally required, as noted in this page from the U.S. Health and Human Services Department Office of the National Coordinator:
NDC codes are grouped into three series of numbers:
- Labeler Code, which indicates the same manufacturer for the same labeler code
- Product code, which indicates the same drug, strength, and dosage form is essential to affirm that the correct product is accessed that matches a prescription, including strength and dosage.
- Package code which indicates package size
FDA Recall Procedures require NDC and Lot Number
Drug recalls are only for affected batches, and FDA will report specific lot numbers. However, NDC codes are also required.[vi],[vii]
Tracking and Supply Chain Lot Numbers and NDC Codes – Homogeneous Case
A homogenous case is defined under section 581(7) of the FD&C Act as “a sealed case containing only a product that has a single National Drug Code number belonging to a single lot.”[viii]
Temperature Excursion Handling Standards Require Documentation and Reporting; Inventories that contain both lot number and NDC are required when there are drug temperature excursions.
CDC requires an “Inventory of affected vaccines” when reporting temperature excursions. See also State standards for the specific data elements required.
CDC and State Temperature Excursion Documentation Reporting Requires NDC-code and Other Standard Data Level of Specificity
State
- Minnesota Department of Health Storage and Handling Mishap Checklist requires reporting of lot numbers. A lot number is generally composed of a drug that an NDC code can identify.[ix]
- North Dakota requires lot number and NDC in its record-keeping and drug Pedigree Standards.[x], [xi]
- Wisconsin requires lot number and NDC in its temperature excursion incident reporting form. See below.
- Rhode Island Department of Health requires Lot number and NDC. Below is an example of the State’s Temperature Excursion Response Worksheet.[xii]
CDC Standards Require that Both Immunization Information Systems (IIS) and Electronic Health Records (E.H.R.) Document Lot Number and NDC Numbers in the normal course of documenting and providing care to patients
According to CDC[xiii] National Drug Codes (NDCs), lot numbers for administered vaccines are required for immunization providers and city/state immunization information system (IIS) staff, and NDCs and lot numbers must be used in either an electronic health record (EHR) or an immunization information system (IIS). The HL7 Data elements have been specified since at least 2007 by CDC.[xiv]
Immunization Guidance for Recording NDCs Requires that E.H.R.s are Capable of Recording, Storing, and Reporting NDC codes and UO or UoS Codes
Prescription Drug Supply Chain Data is relevant in electronic health records. According to FDA,
“When recording the NDC for an administered vaccine, a provider may capture the NDC on the UoU [xv] OR
UoS.[xvi], depending on the established clinical workflow.
- This information should be transmitted or reported (messaged) to the IIS. Typically, this is a function of the EHR and is transmitted in the 5-4-2 format (including the hyphens).
- When documenting administered vaccines that require reconstitution, providers who choose to record the information on the UoU (vial/syringe) should record the NDC from the lyophilized vaccine.
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- This recommendation applies to all reconstituted vaccines, including those with an antigen-containing diluent (such as Menveo and Pentacel).
- For a list of reconstituted vaccines, see the “Vaccine with Diluents: How to Use Them” from the Immunization Action Coalition.When documenting administered vaccines that have been repackaged by third-party vendors into kits with gloves and alcohol wipes, providers should capture and message the vaccine manufacturer’s NDC. [xvii],
- These salable kits contain an NDC from the third-party vendor, as well as an NDC from the vaccine manufacturer.
For vaccines purchased with public funds, providers are required to order new vaccines, report inventory, and submit returns per the UoS (package).” [xviii]
[i] Centers for Disease Control and Prevention. See https://www.cdc.gov/vaccines/hcp/vis/about/required-use-instructions.html
[ii] Immunization Action Coalition See https://www.immunize.org/askexperts/documenting-vaccination.asp
[iii] U.S. Department of Health and Human Services, Food and Drug Administration (FDA), Subpart F – Production and Process Controls, Section 211.101. “Written production and control procedures shall include the following, which are designed to assure that the drug products produced have the identity, strength, quality, and purity they purport or are represented to possess:
(a) The batch shall be formulated with the intent to provide not less than 100 percent of the labeled or established amount of active ingredient.
(b) Components for drug product manufacturing shall be weighed, measured, or subdivided as appropriate. If a component is removed from the original container to another, the new container shall be identified with the following information:
(1) Component name or item code;
(2) Receiving or control number;
(3) Weight or measure in new container;
(4) Batch for which component was dispensed, including its product name, strength, and lot number.
(c) Weighing, measuring, or subdividing operations for components shall be adequately supervised. Each container of component dispensed to manufacturing shall be examined by a second person to assure that:
(1) The component was released by the quality control unit;
(2) The weight or measure is correct as stated in the batch production records;
(3) The containers are properly identified. If the weighing, measuring, or subdividing operations are performed by automated equipment under § 211.68, only one person is needed to assure paragraphs (c)(1), (c)(2), and (c)(3) of this section.
(d) Each component shall either be added to the batch by one person and verified by a second person or, if the components are added by automated equipment under § 211.68, only verified by one person.”
[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51932, Sept. 8, 2008]
[iv] FDA. Regulatory Procedure Manual, Chapter 7: Recall Procedures. See https://www.fda.gov/media/71814/download
[v] FDA. Recalls, Corrections, and Removals. https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices
[vi] FDA. Regulatory Procedure Manual, Chapter 7: Recall Procedures. See https://www.fda.gov/media/71814/download
[vii] FDA. Recalls, Corrections, and Removals. https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices
[viii] U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). See “Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers Guidance for Industry.” June 2021, Labeling. https://www.fda.gov/media/116304/download
[ix] MN Department of Health. See https://www.health.state.mn.us/people/immunize/hcp/mnvfc/vaxchklst.pdf
[x] North Dakota State Board of Pharmacy. See 43-15.2-07. Recordkeeping; See https://www.nodakpharmacy.com/pdfs/lawbooknew.pdf
[xi] North Dakota State Board of Pharmacy. See 43-15.3-06. Pedigree. https://www.nodakpharmacy.com/pdfs/lawbooknew.pdf
[xii] See Rhode Island Department of Health Temperature Excursion Response Sheet. https://health.ri.gov/forms/worksheets/VaccineReturnEmergencyResponseWorksheet.pdf
[xiii] CDC. See https://www.cdc.gov/vaccines/programs/iis/2d-barcodes/downloads/guidance-documenting-ndc.pdf
[xiv] CDC. Current HL7 Data Standards. See https://www2a.cdc.gov/vaccines/iis/iisstandards/vaccines.asp?rpt=cvx
[xv] FDA. Unit of sale (UoS) packages that have different NDCs and lot numbers from those of unit of use (UoU). See https://www.cdc.gov/vaccines/programs/iis/2d-barcodes/downloads/guidance-documenting-ndc.pdf
[xvi] FDA. Unit of sale (UoS) packages that have different NDCs and lot numbers from those of unit of use (UoU). See https://www.cdc.gov/vaccines/programs/iis/2d-barcodes/downloads/guidance-documenting-ndc.pdf
[xvii] FDA. Unit of sale (UoS) packages that have different NDCs and lot numbers from those of unit of use (UoU). See https://www.cdc.gov/vaccines/programs/iis/2d-barcodes/downloads/guidance-documenting-ndc.pdf
[xviii] FDA. Unit of sale (UoS) packages that have different NDCs and lot numbers from those of unit of use (UoU). See https://www.cdc.gov/vaccines/programs/iis/2d-barcodes/downloads/guidance-documenting-ndc.pdf
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