Validation+Rules+Modifications

Revisions in Validation Rules v 2.0 [200908241430]
Additions of text = __underline__ Deletions of text = strikethrough New requirement / renumbering = **bold**

Header of file indicates this is still v2.0; FDA webpage indicates this is v2.1

Labeler information
1.4.2.2: There are two ids __(except for an initial labeler code request, which should be submitted with only one id.)__ 1.4.2.6: One id has the root 2.16.840.1.113883.6.69 and an extension __(except for an initial labeler code request, which should be submitted without this id.)__

Product 2.1.2.14 Name contains no special symbols... //__and no "USP" ("USP" may be in the suffix).__// 2.1.2.21 If the NDC Product Code was previously submitted, with a marketing status date the same or earlier than the current date, then the product and generic name, active ingredient UNII, dosage forms, active ingredient strength, product characteristics of size, shape, color and imprint code are the same //as in the most recent submission for this NDC code//.

Active Ingredient 2.1.4.2 __If the product has no parts, then__ there are one or more active ingredients.

Active moiety 2.1.5.5 Active moiety does not include any of the names in the Active moiety validation //(counter ion)// list __except if the word appears by itself optionally followed by "cation" or "anion" or "ion"__. Packaging 2.1.8.23 If the NDC Product Code has been previously submitted, with a marketing status date the same or earlier than the current date, then the package form code and quantity value and unit are the same //as in the most recent submission for this NDC code//.

Parts 2.1.9.7 Name contains no special symbols... __and no "USP" ("USP" may be in the suffix)//.//__

2.1.9.13 If the NDC Product Code of the part was previously submitted, then the product and generic name, active ingredient UNII, dosage forms, active ingredient strength, product characteristics of size, shape, color and imprint code are the same //as// in the most recent submission for this NDC code Renumbering of previous 2.1.9.13 to 2.1.9.14**
 * New Validation Rule

Marketing Category 2.1.10.6**:** If the code is C73585, then the id extension has the prefix "BLA" __followed by 6 digits__. 2.1.10.8: If the code is C73594 __or C73605__ then the id extension has the prefix "NDA" followed by 6 digits

2.1.10.17 If the code is C73626, C73603, C73604, C76314, C76313 or C73627, then the document has at least one section with the code 51945-4. Renumbering of previous 2.1.10.17 to 2.1.10.18. Renumbering of previous 2.1.10.18 to 2.1.10.19. Renumbering of previous 2.1.10.19 to 2.1.10.20. Renumbering of previous 2.1.10.20 to 2.1.10.21.**
 * New Validation Rule

Marketing Date

2.1.11.7 If there is a high value, then it is not less than the low value.**
 * New Validation Rule