Header - Structured Product Labeling (SPL) Implementation Guide with Validation Procedures

4.1.1 Document Type

4.1.1.1 Document types for labeling and listing are in the following Table 8. Some validation procedures vary by what FDA Center has authority over the types of products submitted with the respective document.

Table 8: Document Types for Labeling , Listing, and other Product Submissions

Code Display Name FDA Center

53409-9 BULK INGREDIENT CDER

60684-8 CELLULAR THERAPY CBER

34390-5 HUMAN OTC DRUG LABEL CDER

34391-3 HUMAN PRESCRIPTION DRUG LABEL CDER 75031-5 Human Compounded Drug Label CDER 53407-3 LICENSE BLOOD INTERMEDIATES/PASTE LABEL CBER 53408-1 LICENSED MINIMALLY MANIPULATED CELLS LABEL CBER 53406-5 LICENSED VACCINE BULK INTERMEDIATE LABEL CBER

55439-4 MEDICAL DEVICE CDRH

58475-5 MEDICAL FOOD< CFSAN

53405-7 NON-STANDARDIZED ALLERGENIC LABEL CBER

50577-6 OTC ANIMAL DRUG LABEL CVM

69403-4 OTC MEDICAL DEVICE LABEL CDRH

50576-8 OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL CVM 50574-3 OTC TYPE B MEDICATED FEED ANIMAL DRUG LABEL CVM 50573-5 OTC TYPE C MEDICATED FEED ANIMAL DRUG LABEL CVM

60683-0 PLASMA DERIVATIVE CBER

50578-4 PRESCRIPTION ANIMAL DRUG LABEL CVM 69404-2 PRESCRIPTION MEDICAL DEVICE LABEL CDRH

53404-0 VACCINE LABEL CBER 50575-0 VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL CVM 50572-7 VFD TYPE B MEDICATED FEED ANIMAL DRUG LABEL CVM 50571-9 VFD TYPE C MEDICATED FEED ANIMAL DRUG LABEL CVM 78745-7 Recombinant Deoxyribonucleic Acid Construct CVM

77647-6 Animal Compounded Drug CVM

78744-0 Drug for Further Processing CDER

4.1.1.2 If a document with the same set id has been previously submitted, then it is of the same type, except if the previous document type was Bulk Ingredient (53409-9) and the present document type is Drug for Further Processing (78744-0).

4.1.1.3 If active ingredient code is on the list of active ingredients approved for vaccines, then the document type code is 53404-0 (Vaccine Label) or licensed vaccine bulk intermediate (53406-5).

4.1.1.4 If the product type “changes” from Human Prescription Drug (34391-3) to Human OTC Drug (34390-5), then submit a new listing file with new NDC codes for the OTC drug.

4.1.2 Labeler information

<id extension="100000007" root="1.3.6.1.4.1.519.1"/> <name>Acme drug company</name>

Validation Procedures

4.1.2.1 There is one labeler

4.1.2.2 There is one id, the labeler’s DUNS number, and name is as in Section 2.1.5. 4.1.2.3 The set id is not associated with any top level product with a different NDC

Labeler Prefix

4.1.2.4 There is no other element besides id (the labeler’s DUNS Number), name and registrant.

4.1.3 Registrant information <document> <author> <assignedEntity> <representedOrganization> <assignedEntity>

<id extension="100000008" root="1.3.6.1.4.1.519.1"/> <name>Acme drug company</name>

Validation Procedures

4.1.3.1 There may be registrant information

4.1.3.2 If there is a registrant, then there is one id, (the registrants DUNS number) and a name as in Section 2.1.5.

4.1.3.3 There is no other element besides registrant’s id, registrant’s name and establishments.

4.1.3.4 There is not more than one registrant element.

4.1.4 Establishment information <document> <author> <assignedEntity> <representedOrganization>  <assignedEntity> <assignedOrganization>  <assignedEntity>

<id extension="1000000019" root="1.3.6.1.4.1.519.1"/> <name>Middleton Manufacturing company</name>

</assignedOrganization> <performance> <actDefinition> <code code="C43360" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="manufacture"/> Validation Procedures

4.1.4.1 If the marketing status code for any of the products that is or includes a drug is

not completed, then there are one or more establishments.

4.1.4.4 Establishment (“assignedOrganization”) has no other element besides id (the DUNS Number) and name.

4.1.4.5 The establishment id matches an establishment with same id (the DUNS Number) submitted in documents of type “establishment registration” in the same or previous calendar year

4.1.4.6 There are one or more business operations.

4.1.4.7 Act definition display business operation name matches corresponding business operation code

4.1.4.8 The code comes from the business operations list except for import (C73599) and united states agent (C73330) and distributes drug products under own private label (C73608)

4.1.4.9 Act definition code (business operation code) matches business operation code for an establishment with same id previously submitted in documents of type “establishment registration” in the same or previous calendar year

4.1.4.10If any of the products without a marketing completion date in a Prescription Animal Drug (50578-4), OTC Animal Drug (50577-6) or Animal Medicated Article or Medicated Feed (50576-8, 50574-3, 50573-5, 50575-0, 50572-7, 50571-9) listing has establishments with operations of manufacture (C43360) and also relabel (C73607), or repack (C73606), then there is no product source. 4.1.4.11If the document type is Human Compounded Drug Label (75031-5), then the

establishment’s business operation is Human drug compounding outsourcing facility (C112113).

4.1.4.12If the document type is Animal Compounded Drug Label (77647-6), then the establishment’s business operation is Outsourcing Animal Drug Compounding (C122061).

4.1.4.13If the product has a reference source, then one of the operations is Repack (C73606) or Relabel (C73607).

4.1.4.14If in a Bulk Ingredient (53409-9) listing there is a product with marketing category Bulk Ingredient (C73626) and without a marketing completion date, then one or more establishments with operation of API manufacture (C82401) are included.

4.1.4.15If there is any product that is or includes a drug and has no marketing

completion date and no product source, then at least one establishment with a manufacture operation is included such as API manufacture (C82401),

manufacture (C43360), or positron emission tomography drug production (C91403).

4.1.4.16 If in a Prescription Animal Drug (50578-4), OTC Animal Drug (50577-6) or Animal Medicated Article or Medicated Feed (50576-8, 50574-3, 50573-5, 50575-0, 50572-7, 50571-9) listing there is a product without a marketing completion date, with an active ingredient other than those in the designated medical gas validation list, and without product source, then one or more establishments with operation of API manufacture (C82401) are included. 4.1.4.17Compounded Drug Report has only one Establishment

4.1.4.18DUNS number is not associated with any other set id for Compounded Drug report.

4.1.5 Business Operation Product

The following example shows how the business operations are specified for particular products. It is done by replicating the business operation (actDefinition) elements, and connecting each with one product as shown below:

</manufacturedMaterialKind></manufacturedProduct></product> </actDefinition></performance>

Validation Procedures

4.1.5.1 If the document type is under CDER authority, then an establishment operation listed is linked to at least one listed product or part product, except for Human Compounded Drug Label (75031-5).

4.1.5.2 If the document type is under CDER authority, then each listed product having an active marketing status is linked from at least one establishment operation, except for Human Compounded Drug Label (75031-5).

4.1.5.3 If the document type is under CDRH, CFSAN, or CVM authority or if it is Human Compounded Drug Label (75031-5) or Animal Compounded Drug Label (77647-6), then there is no operation-product link. (NDC product code- to-establishment-business operation data relationship)

4.1.5.4 If the document type is under CBER authority, then the operation-product link is optional. (NDC product code-to-establishment-business-operation data relationship)

In document Structured Product Labeling (SPL) Implementation Guide with Validation Procedures (Page 81-86)