There are several significant differences in the regulation of unapproved new drugs for humans as compared to unapproved new animal drugs.
Unapproved new human drugs are in violation of Section 505(a) of the Act. New human drugs cannot be seized as violating Section 505(a) of the Act on a 301(k) charge. New human drugs seized under a 505(a) charge cannot be reconditioned but must be destroyed (304(d)(1)). In the past where a human drug product can be reconditioned in a manner to bring it into compliance, the libel has been amended from a 505 charge to a misbranding charge to provide for appropriate relabeling or other reconditioning.
An unapproved new animal drug if sold commercially is adulterated within the meaning of 501(a)(5) or 501(a)(6) of the Act and may be seized on a 301(a) or 301(k) charge. There is no exemption under Section 304 precluding the reconditioning of an animal drug seized under 501(a)(5) or (6) of the Act.
Where a new animal drug can be brought into compliance after seizure on a 501(a)(5) or 501(a)(6) charge, the *Center* may enter into a suitable consent decree permitting reconditioning. Some instances where reconditioning may take place are:
- Deletion of excessive therapeutic claims which caused the product to be a new animal drug.
- Deletion of any claim which would cause the product to be within FDA jurisdiction, such as removal of drug claims changing a shampoo product into a grooming aid not subject to regulation under the Act.
- Conversion to an investigational animal drug subject to 21 CFR 511 requirements.
- Approval of an NADA after seizure has taken place.
*Material between asterisks is new or revised*
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
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