Contents

SUBCHAPTER 710 - RECONDITIONING AND DESTRUCTION

710 - POLICY

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 940 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.

711 - DEFINITIONS

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.

Destruction - The procedures involved in rendering a product unsalvageable. Destruction may be accomplished by burning, burial, etc.

Denaturing - Decharacterization of a product, whereby it is made unusable for its originally intended purpose.

712 - 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 940.

SUBCHAPTER 720 - CONSENT DECREE

720 - POLICY

Seized goods may be released under bond, by court order to be destroyed or brought into compliance. The order normally provides for supervision of the operation by FDA. Release of the bond depends upon your certification the court order has been satisfactorily executed.

Do not undertake reconditioning until you are certain a court order has been entered, bond posted, and goods released by the marshal. Be certain the identity and amount of goods corresponds with that seized. Be sure you are familiar with the terms of the court order.

Reconditioning or destruction may, at times, be permitted without continuous supervision. However, the lot must be checked before operations start, rechecked intermittently and upon completion. Supervision must be sufficient to assure none of the lot was diverted. All of the goods involved in the action, including reconditioned goods as well as discarded material such as screenings, old labels, etc., must be accounted for. If organoleptic examination will not permit a judgement regarding the degree of compliance, collect suitable samples for laboratory examination. If the reconditioning process does not appear to comply with the order, immediately advise the claimant and your supervisor.

721 - RELABELING

Before permitting any relabeling operation, be sure FDA has approved the proposed new label. Provide an accounting of disposition of the old labels. Submit three (3) copies of the new label and three (3) copies of the old label with your report of the operation.

722 - REWORKING

Before permitting any manipulation, determine the proposed process has been approved by your district. This includes ensuring the facilities and equipment to be used are sanitary and effective for the proposed process. Report the yield of the reworked product.

723 - SEGREGATION

Thoroughly examine goods set aside as legal, and submit samples for laboratory examination, if indicated. Follow up on disposition of reject material to prevent illegal diversion. Describe the method of destruction of unfit material resulting from the segregation process.

724 - DESTRUCTION

Supervise and describe the method of destruction of goods, labels, labeling, etc. and report the amount destroyed.

725 - DISPOSITION OF REJECTS

Arrange for reject materials to be destroyed in an approved manner, under your supervision. The method of disposition will have already been approved by the District, and in some cases set out in the Consent Decree.

726 - RELEASE OF GOODS

Do not authorize release of reconditioned goods, unless specifically directed by your supervisor. Formal release is normally handled by district headquarters.

729 - REPORTING

Promptly submit a detailed report upon conclusion of the operation. Where the operation is prolonged, submit interim progress reports. Include the following information in your report of the operation:

1. identification of the case (sample number, court number, FDA number, product and claimant).
2. description of the method of reconditioning or destruction.
3. disposition of rejects; explanation for unaccounted goods.
4. findings of field examinations.
5. exhibits and samples collected. Do not pay for samples collected during reconditioning operations conducted under a Consent Decree.
6. expenses, including time spent in supervision and travel, mileage, per diem, and incidental expenses.

SUBCHAPTER 730 - DEFAULT DECREE

730 - POLICY

When no claimant appears in a seizure case, the court issues a Default Decree of Condemnation condemning the goods. It may or may not specify the manner of disposal. Disposition, whether by destruction, distribution to charitable institutions or sale by salvage must be approved and monitored by the Government.

Primary responsibility for disposition of seized lots following a default decree lies with the U.S. Marshal’s Office.

FDA inspectional personnel frequently accompany the marshal to witness the operation. Although you are there in an advisory capacity, assist the marshal in every way to assure compliance with the court order.

739 - REPORTING

Promptly submit a written report of your observations upon completion of the operation. See IOM 729.

SUBCHAPTER 740 - COMPLIANCE ACHIEVEMENT

740 - POLICY

FDA uses a blend of industry voluntary correction and regulatory actions to help achieve industry compliance.

A voluntary corrective action is defined as the observed voluntary repair, modification, or adjustment of a violative condition, or product. For purposes of this definition, violative means the product or condition does not comply with the Acts or associated regulations enforced by the Agency.

Voluntary destruction in lieu of seizure of small lots of violative goods shall be encouraged, where the proposed method is adequate. Supervision of voluntary segregation and denaturing of violative goods shall not be provided, except where it can be accomplished with dispatch, minimal inspectional resources, and in a manner consistent with procedures outlined in this Sub Chapter.

The most extensive actions in this area usually occur in disaster situations. Follow instructions in IOM Subchapter 940 - Disaster Procedures.

Do not engage in actual destruction, reconditioning, repair, modification, etc. of goods. This is the responsibility of the owner or dealer. You are in the capacity of witness only. Samples should be collected of violative goods prior to voluntary destruction to support subsequent action against the responsible individuals. Take photographs where applicable. See IOM 591.01 and IOM 749.

741 - DESTRUCTION

Before you supervise destruction, be sure management is aware the action is voluntary and that you are acting only as a witness. See IOM 749.

Witness all destructions personally, making certain destroyed goods are rendered totally unsalvageable for food, drug, device, etc. use. Keep in mind personal and public safety. Exercise proper precautions in dealing with potentially dangerous substances and situations. Comply with local ordinances regarding the disposition of garbage and trash.

Note certain products should not be disposed of in a conventional manner (e.g.: sanitary landfill, flushing down the drain, etc.). In particular, certain products which have been banned in the past (chloroform, methapyrilene, hexachlorophene, PCB, etc.), are classified by EPA as hazardous and toxic substances and may require a special method of disposal by a licensed hazardous disposal facility. Any possible hazardous or toxic substance (carcinogen, mutagen, etc.) should not be disposed of without prior consultation by the firm with the U.S. Environmental Protection Agency and/or the regulating state authority. Refer to 21 CFR 25 and the National Environmental Protection Act for guidance regarding the environmental impact of voluntary destructions.

741.01 - DEA Controlled Drugs

FDA and DEA have a written policy to permit FDA representatives, in certain situations, to witness the destruction of DEA controlled drugs. The procedures and instructions to follow when these drugs are destroyed are:

DEA Approval - FDA and the Drug Enforcement Administration (DEA) have a mutual, written policy concerning witnessing the destruction of drugs under the distribution control of DEA. This provides for FDA, upon receiving a request to witness such destruction, to advise the DEA regional office and obtain approval for the action. If approval is requested by telephone and verbally approved, the approval should be reduced to writing for the record.

Procedure - The necessity for FDA personnel to witness destruction of DEA controlled drugs will normally happen only when FDA is already present in the firm, encounters DEA controlled drugs, and is requested to witness destruction, or when DEA controlled drugs are to be destroyed at the same time FDA is witnessing destruction of drugs not under DEA control.

If you are in a firm either making an inspection or to witness destruction of drugs under FDA's distribution control, and the firm requests you also witness destruction of DEA controlled drugs, do not commit yourself. Telephone your supervisor for instructions. You will be advised whether or not to proceed after your district communicates with DEA. In all other situations refer the requester to DEA.

If the request to witness the destruction is approved, observe the destruction, and prepare DEA Form DEA 41 . as follows:

1. List each dosage form of each drug on a separate line. Calculate amounts for columns 6 and 7.
2. Line out the inappropriate sentences in the paragraph following line 32.
3. Date and sign the form.
4. Type or print your name, title, and district under your signature.

742 - RECONDITIONING

The supervision of voluntary segregation of violative goods without the regulatory safeguards of seizure should be avoided. Voluntary segregation and destruction of violative lots should be encouraged; but under no circumstances should you supervise the voluntary segregation and salvage of unfit goods, regardless of the nature of the violation or the size of the lot. Be sure management is aware the segregation is its responsibility. Collect samples where indicated, and/or advise the dealer or owner of his responsibilities under the law. If the dealer decides to voluntarily destroy any lot, refer him to the National Environmental Protection Act (NEPA). See IOM 741.

749 - REPORTING

Report any voluntary correction of a problem unrelated to a district recommendation for regulatory action.

749.01 - Documenting Voluntary Destruction

Prior to supervising voluntary destruction, prepare a statement on the firm's letterhead or on an FDA 463a, Affidavit, providing the following information.

1. voluntary nature of the action, with you as a witness.
2. name of the product, including applicable code marks.
3. condition of the lot.
4. amount.
5. method of destruction.
6. signature of responsible individual.

749.02 - Compliance Achievement Reporting

The following are examples of compliance actions to be described in the report, EI Record, and reported into the Compliance Achievement Reporting System in FACTS (Exhibit 590-B) per district office SOP's:

Violative Products - Voluntary destruction by the person in possession of any violative product.

Destruction by Cooperating Officials - Destruction of violative products by a cooperating food or health official, where such product was discovered by and reported to such official by FDA when those officials were doing work for FDA under contract. Do not report formal condemnation by cooperating officials in the usual course of their independent work.

Manufacturer's Raw Materials - Voluntary destruction of manufacturer's raw materials during the course of an inspection. For example, decomposed cream or filthy milk.

Capital Improvements - Significant improvements correcting a violative condition such as new equipment, rodent-proofing, etc. These should be reported at follow-up inspections where actual improvement has been accomplished or committed, and the improvement is the result of a previous FDA observation or suggestion and not as a result of a seizure, injunction or prosecution.

Correction of GMP Deviations - During an inspection the investigator observes GMP deficiencies have been corrected since the previous EI. These corrections are based on the previous FDA 483.

Formula/Label Correction - Based on a sample analysis, consumer complaint, etc., a product formula or label is corrected.

Additional Personnel - Employment of personnel for quality improvement or improved quality control.

Educational and/or Training - Initiation of an educational and/or training program among employees or producers, or other general industry movement to improve conditions.

Do not report:

1. Recalls, although voluntary, because they are already recorded elsewhere (FACTS).
2. Corrections which are not directly attributable to the efforts of FDA, or states under contract to FDA.
3. Corrections as a result of a seizure, injunction or prosecution.

For products involving the field compliance testing of diagnostic X-Ray equipment, use form FDA 2473a to report these actions, as directed by the Compliance Program. Submit the completed form to your district. Your district will submit a copy to the CDRH, Office of Compliance and maintain a copy for the district files.