We are often asked for the SECRET FDA Code on Consent Decrees, so here is what you need to know:
SUBCHAPTER 2.4 – CONSENT DECREE
2.4 – CONSENT DECREE
2.4.1 – 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 judgment 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.
2.4.2 – 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.
2.4.3 – 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.
2.4.4 – 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.
2.4.5 – DESTRUCTION
Supervise and describe the method of destruction of goods, labels, labeling, etc. and report the amount destroyed.
2.4.6 – 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.
2.4.7 – RELEASE OF GOODS
Do not authorize release of reconditioned goods, unless specifically directed by your supervisor. Formal release is normally handled by district headquarters.
2.4.8 – 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:
- Identification of the case (sample number, court number, FDA number, product and claimant).
- Description of the method of reconditioning or destruction.
- Disposition of rejects; explanation for unaccounted goods.
- Findings of field examinations.
- Exhibits and samples collected. Do not pay for samples collected during reconditioning operations conducted under a Consent Decree.
- Expenses, including time spent in supervision and travel, mileage, per diem, and incidental expenses.
Your Link to the FDA Files on Consent Decree Work:
What it says:
Section 6-2-13 – Consent Decree