Sec. 625.300 Unapproved New Animal Drugs - Follow-up Action to Approved *Warning*
Letter - Direct Reference Seizure Authority (CPG 7125.36)
REGULATORY ACTION GUIDANCE:
Direct reference seizure of new animal drugs without approved New Animal Drug Applications, section 501(a)(5) cases, may be submitted by district offices directly to the Division of Compliance Management and Operations, HFC-210, provided all of the following criteria are met:
1. CVM approval has been obtained and a *Warning* letter has been issued within the
previous twelve months charging a section 501(a)(5) violation for the product in question,
referencing section 512(a)(1)(A).
2. There has been no change in the label, labeling, or in the product since CVM
approval of the previously issued section 501(a)(5) *Warning* letter pertaining to the
unapproved new animal drug product.
REMARKS:
1. Send a copy of the seizure recommendation transmittal to CVM, Case Guidance Branch
(HFV-236).
2. Interstate origin of the drug or its components must be well documented.
3. Direct reference seizure authority does not extend to section 501(a)(5) violations
based on the extra-label use of approved new animal drugs.
SPECIMEN CHARGE:
Article was adulterated when introduced into and while in interstate commerce and is
adulterated while held for sale after shipment in interstate commerce, within the meaning
of 21 U.S.C. 351(a)(5), in that the article is a "new animal drug" within the
meaning of 21 U.S.C. 321(w), which is unsafe within the meaning of 21 U.S.C.360b(a)(1)(A)
since no approval of an application filed pursuant to 21 U.S.C. 360b(b) is in effect with
respect to its use or intended use.
*Material between asterisks is new or revised*
Issued: 4/3/91
Revised: 4/16/91, 3/95