Updated: 2008-02-06
Contents
2.3 - RECONDITIONING AND DISTRUCTION
2.3.1 - DEFINITIONS
2.3.1.1 - Reconditioning
2.3.1.2 - Destruction
2.3.1.3 - Denaturing
2.3.2 - DISASTERS
2.3 - RECONDITIONING AND DISTRUCTION
Sections 304 and 801 of the FD&C Act [21 U.S.C. 334 and 381] provide the legal basis for reconditioning or destruction of goods under domestic seizure or import detention.
Reconditioning and destruction are the means whereby goods are brought into compliance with the law, or permanently disassociated from their intended use. Manpower may not be expended on supervision of reconditioning and destruction of goods except under administrative controls, detention, or emergency and disaster operations. See IOM 8.5 for operations in disasters.
FDA does not seek or condone the destruction of books or other publications. FDA policy and practice tries to be sensitive to the potential First Amendment issues associated with the regulation of books and other printed materials that function as labeling of a product. See Compliance Policy Guide 140.100. In the context of judicial enforcement, disposition of any labeling subject to the court's jurisdiction is determined by the court. In a voluntary compliance situation, the disposition is the prerogative of the manufacturer, distributor, wholesaler, or retailer. Agency policy does not authorize field employees to direct or limit the options for disposition of violative labeling or other printed materials in such circumstances. Good judgement should always be exercised in such matters.
Section 536(b) of the FD&C Act [21 U.S.C. 360ll (b)] provides authority for electronic products to be reworked if FDA determines they can be brought into compliance with radiation performance standards. Therefore, reconditioning of radiation-emitting products must be approved by CDRH, Office of Compliance, prior to implementation to assure compliance with performance standards. If a foreign manufacturer conducts the reconditioning, the district should notify both the importer/consignee and the foreign manufacturer's agent of all FDA actions.
2.3.1 - DEFINITIONS
2.3.1.1 - Reconditioning
The reworking, relabeling, segregation, or other manipulation which brings a product into compliance with the law, whether or not for its original intended use.
2.3.1.2 - Destruction
The procedures involved in rendering a product unsalvageable. Destruction may be accomplished by burning, burial, etc.
2.3.1.3 - Denaturing
Decharacterization of a product, whereby it is made unusable for its originally intended purpose.
2.3.2 - DISASTERS
Reconditioning and destruction of contaminated merchandise in times of disasters can assume national proportions and is handled differently than normal operations.
Instructions for operations pertaining to reconditioning and destruction during non-attack type disasters is covered in IOM 8.5.
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