Validation+Rules+Modifications+-+2010

Revisions in Validation Rules v 2.0 [Revision 201005011423]
Additions of text = __underline__ Deletions of text = strikethrough New requirement / renumbering = **bold**


 * NEW 1.1.10** There is no confidentiality code on anything but inactive ingredients and assigned establishments outside establishment registrations.


 * NEW 1.4.1.2** The displayName matches the code

CHANGE: 1.4.1.2 TO **1.4.1.3** There is no title CHANGE: 1.4.1.3 TO **1.4.1.4** The document body is empty


 * NEW : 1.5.1.2** Display name matches code

REPLACES The effective time year matches the current year

CHANGE: 1.5.1.2 tO **1.5.1.3** There is no title CHANGE: 1.5.1.3 to **1.5.1.4** The document body is empty

REVISION: 1.5.1.5 For a No change notification (53410-7), Out of business notification (53411-5), __an Establishment Registration (51725-0) with the same set id__ has been previously submitted. From 1.5.1.5 The setid of a No change notification (53410-7) or Out of business notification (53411-5) has been previously submitted.


 * NEW: 1.5.1.6** If a document with the same set id has been previously submitted, then it is not an Labeler Code Request (51726-8), Establishment Registration (51725-0) or No change notification(53410-7).
 * NEW: 1.6.1.2** If a document with the same set id has been previously submitted, then it is not an Labeler Code Request (51726-8), Establishment Registration (51725-0), No change notification(53410-7), or Out of business notification (53411-5).

CHANGE: 1.6.1.2 – 1.6.1.8 TO **1.6.3.3** – **1.6.3.9**

Previous 1.6.3.9 is now 1.6.3.11
 * NEW 1.6.3.10** The code comes from the business operations list except for C73599 (import) and C73330 (United States Agent)


 * NEW 1.6.3.12** If any of the products without a marketing completion date in this listing has no product source, then establishments with operation of API Manufacture (C82401) or Manufacture (C43360) are included.


 * ON HOLD FOR NOW!! Business Operation Product Section (1.6.4)**

**NEW 1.6.4.1** There is zero or one operation-product links for each business operation (actDefinition) and those act definition elements are replicated for each product to which that business operation applies


 * NEW 1.6.4.2** Each product link has a code referencing a product code in the document

CHANGE: Section 2.1.2 Product is now **section 2.2 Product** Example procedure will be 2.2.1.1 rather than 2.1.2.1

REVISED: 2.1.2.14 Name contains no special symbols (e.g., no “®”or “™” etc) and no “USP” or __dosage forms__

REVISED: 2.1.2.14 Generic medicine name contains no special symbols (e.g., no “®”or “™” etc__) and no “USP” or__ __dosage forms__


 * NEW 2.2.1.21** Generic medicine name contains no suffix

PREVIOUS 2.2.1.21 now 2.2.1.22

CHANGE: 2.1.3 Product source is now **2.2.2 Product Source** CHANGE: 2.1.3.2 is now **2.2.2.3** CHANGE: 2.1.3.3 is now **2.2.2.2**


 * NEW 2.2.2.4** NDC Product Code for the source is not the same as the NDC Product Code for the product

CHANGE: 2.1.4.2 – 2.1.4.4 are now **2.2.3.3** through **2.2.3.5**

REVISED: 2.1.4.5 is now **2.2.3.6** Numerator and denominator have a value __greater than zero__ and a unit


 * NEW 2.2.3.7** If the document type is for ‘bulk ingredient’ (53409-9), then numerator and denominator are the same

CHANGE: 2.1.4.6 - 2.1.4.10 are now **2.2.3.8** through **2.2.3.12** CHANGE: 2.1.5 Active moeity is now **2.2.4 Active moeity** CHANGE: 2.1.6 Reference Ingredient for Strength is now **2.2.5 Reference Ingredient for Strength** CHANGE: 2.1.7 Inactive ingredient is now **2.2.6 Inactive Ingredient** CHANGE: 2.1.7.6 now REV 2.2.6.6 If there is a strength, then numerator and denominator have a value __greater than zero__ and unit CHANGE: 2.1.8 Packaging is now **2.2.7 Packaging**

REVISED: 2.1.8.3 now **2.2.7.3** Numerator has a value __greater than zero__ and unit REMOVED 2.1.8.24 There should be only one package element for each package code, i.e., the same package is not described more than once, except under parts.

2.2.7.24 If the NDC Package Code is mentioned elsewhere in the document, then the package form code and quantity value and unit are the same

CHANGE: 2.1.9 Parts is now **2.2.8 Parts** 2.2.81

2.1.9.2 – 2.1.9.6 are now **2.2.8.3** – **2.2.8.7**
 * NEW 2.2.8.2** If the product has parts, then at least one part has one or more active ingredients.

REVISED: **2.2.8.8** Name contains no special symbols (e.g., no “®”or “™” etc) and no “USP” or __dosage forms__ 2.1.9.8 is now 2.2.8.9 There is a form code and the procedures for product form code apply.

Former 2.1.9.9.and 2.1.9.10: REMOVED

CHANGE: 2.1.9.11 through 2.1.9.13 are now **2.2.8.10** – **2.2.8.12**


 * NEW 2.2.8.13** IF the NDC Product code is mentioned elsewhere in the document, then the product and generic name, dosage form, UNII and strength of all ingredients are the same.

CHANGE: 2.1.10 Marketing category is now **2.2.9 Marketing category** CHANGE: 2.1.10.18 - 2.1.10.20 are now **2.2.9.2 through 2.2.9.4** CHANGE: 2.1.10.2 - 2.1.10.16 are now **2.2.9.5 through 2.2.9.19** with abbreviations in parentheses for all.


 * New: 2.2.9.20** If the document type code is: 50577-6 (OTC animal drug), 50576A), 50574-3 (OTC type B), 50573-5 (OTC type C), 50578-4 (presanimal drug), 50575-0 (VFD type A), 50572-7 (VFD type B) or 50type C), then the marketing category is: C73583 (ANADA), C7(Conditional NADA), C73593 (NADA), C73614 (unapproved homeopathic), C73613 (unapproved medical gas) or C73627 (unapproved drug other).


 * New: 2.2.9.21** If the marketing category is C73583 (ANADA), C73588 (Conditional NADA), C73593 (NADA), then the document type code is: 50577-6 (OTC animal drug), 50576-8 (OTC type A), 50574-3 (OTC type B), 50573-5 (OTC type C), 50578-4 (prescription animal drug), 50575-0 (VFD type A), 50572-7 (VFD type B) or 50571-9 (VFD type C)


 * New 2.2.9.22** If the marketing category is C73626 (bulk ingredient), then the document type is 53409-9 (bulk ingredient)


 * New 2.2.9.23** IF the document type is 53409-9 (bulk ingredient), then the marketing category is C73626 (bulk ingredient)

REMOVED: 2.1.10.17 If the code is C73626, C73603, C73604, C73614, C73613 or C73627 then the document has at least on section with the code 51945-4

CHANGE: 2.1.11 Marketing date is now **2.2.10 Marketing date** CHANGE: 2.1.12 DEA schedule is now **2.2.11 DEA Schedule** CHANGE: 2.1.13 Color is now **2.2.12 Color** CHANGE: 2.1.14 Shape is now **2.2.13 Shape**


 * New 2.2.13.5** There is only one shape element

CHANGE: 2.1.15 Size is now **2.2.14 Size**

REVISED: 2.2.14.5 Value is a whole number __greater than zero__


 * New 2.2.14.6** There is only one size element

CHANGE: 2.1.16 Scoring is now **2.2.15 Scoring** CHANGE: 2.1.17 Imprint code is now **2.2.16 Imprint code**


 * New 2.2.16.3** There is only one imprint code element

CHANGE: 2.1.18 Flavor is now **2.2.17 Flavor** CHANGE: 2.1.19 Contains characteristics is now **2.2.18 Contains characteristics** CHANGE: 2.1.20 Image is now **2.2.19 Image** CHANGE: 2.1.21 is now **2.1.20 Route of administration**

REVISED: 2.2.20.1 __If the document type is not for "bulk ingredient" (53409-9) and product is not a top-level product whose form code is C47916__, then there is one or more "consumed in" substance administration with route code top-level product whose form code is C47916,


 * NEW: 2.2.20.4** If the document type is for ‘bulk ingredient’ (53409-9), then route code is “not applicable” or not present at all.


 * NEW 2.2.20.5** The route code cannot be "not applicable" (C48623) for document types other than bulk ingredient (53409-9)

CHANGE: 2.2 Content of labeling is now **2.3 Content of labeling** CHANGE: 2.2.1 Section is now **2.3.1** CHANGE: 2.2.1.1 – 2.2.1.3 are now **2.3.1.1 – 2.3.1.3**


 * NEW 2.3.1.4** id does not match any other id in the document


 * NEW 2.3.1.5** id does not match any other id across all sections, documents, or any id other than the id of the same section previously submitted

CHANGE: 2.2.1.4 – 2.2.1.9 are now **2.3.1.6** through **2.3.1.11** CHANGE: 2.2.2 Images is now **2.3.2 Images** CHANGE: 2.2.2.1 – 2.2.2.3 are now **2.3.2.1 – 2.3.2.3**


 * NEW 2.3.2.4** Size of image file is less than 1 MB

REVISED: 2.3.2.5 File __is a JPEG image and the__ name has the extension “.jpg”

CHANGE: 2.2.2.5 – 2.2.2.6 are now **2.3.2.6** through **2.3.2.7** CHANGE: 2.2.3 Highlights is now **2.3.3 Highlights**


 * NEW 2.3.4 Required Content of Labeling Sections**


 * NEW 2.3.4.1** If the document is not a UDI submission, then there is a section with the code 51945-4 (PDP) with an image of carton/container label.


 * NEW 2.3.4.2** If the marketing category code is not C73626 (bulk ingredient) or C73613 (unapproved medical gas), then there is at least one other content of labeling section besides those with the codes 48780-1 and 51945-4.


 * NEW 2.3.4.3** If the approval number is in the medication guide validation list, then there must be such a Medication Guide section (42231-1). ||