Relabeling of New Drugs
At times an importer of record may desire to bring a drug shipment detained on a new drug charge into compliance by revising the labeling to remove claims which placed the product into the category of a new drug. Sometimes such a drug appears to be composed of harmless ingredients. A typical example is Chinese herbal medications labeled for the promotion of blood circulation, sexual rejuvenation, headaches, anemophobia, back neuralgia, bone pain, acute or chronic neuralgia and other pain caused by rheumatism. Do not permit the relabeling of a drug detained on a new drug charge as a means to bring the item into compliance. To do otherwise is not in the best interest of the consuming public. Experience has shown that such drugs may contain undeclared ingredients, such as
phenylbutazone and aminopyrine, which present serious hazards to the users. Likewise, it should be noted that any drug seized in domestic commerce on a new drug charge cannot be relabeled and introduced into commerce, but if condemned by the court must be
destroyed.
Reconditioning of Green Coffee and Cocoa Beans Due to the Presence of Live and/or Dead Insects
This procedure was originally instituted for reconditioning green coffee beans detained under Administrative Guideline 7403.01 due to the presence of live and/or dead insect infestation (CPG 510.500). The procedure has now been expanded to include cocoa beans (CPG 515.750).
In the past when green coffee beans were detained for live and/or dead insect infestation, the importer of record submitted an Application for Reconditioning (FD-766) indicating
fumigation and cleaning prior to delivery to the roasting plant. The coffee industry contended that part of the processing of coffee beans at most roasting plants includes a cleaning
procedure for removal of dead insects and extraneous material. The cleaning and rebagging before processing purportedly causes duplication of cleaning and results in additional
charges for the importer and ultimately for the consumer.
To avoid duplication the following alternate reconditioning procedure can be used if the importer chooses.
After a detention due to live insect infestation is issued, the importer of record or consignee must submit an Application for Reconditioning (FD-766). The FD-766 shall identify the procedure for fumigation (including name and amount of fumigant, time of exposure etc.) which is to be used. The application shall also include the name and address of the roasting plant where the cleaning phase will be accomplished; the identity of the equipment to be used in the cleaning operation; the date and time cleaning operations are to begin; and that a signed statement will be submitted to FDA attesting that the reconditioning was properly carried out by the processor when the entire reconditioning has been completed. When it is deemed necessary, for monitoring purposes, the FD-766 should be approved with the condition that rejects (tailings) are to be held for FDA examination and subsequent destruction under U.S. CBP or FDA supervision.
As part of the approval of this application (FD-766) the fumigation must be accomplished prior to permitting the lot's movement to the roasting plant. The district, at its discretion, may examine the lot to determine the effectiveness of the fumigation. If the stated date or time of cleaning has to be changed, the importer should notify the district supervising the
reconditioning at least 72 hours prior to the time noted in the application.
At the time of the initial submission of the FD-766 application under this procedure, the file should be checked to determine if there has been a recent inspection of the cleaning facility. If not, the application should be approved with the condition that the roasting plant will be inspected to determine if it is acceptable to FDA prior to the movement of the beans to that plant. If the plant is found acceptable, the district will advise the importer that the lot may be sent to the roasting plant. Inspections should be made without undue delay to avoid causing importers excessive storage charges.
After the initial inspections the districts, at their discretion, may make follow-up inspections to determine if the plants' cleaning operations are being maintained to properly recondition detained lots.
All time to conduct inspections to determine if the processors plant and equipment is
acceptable and those made to check on specific lots after reconditioning shall be included in the supervisory charges issued to the importer of record. All movement of detained lots shall be under CBP's bond and by acceptable conveyances.
The procedure outlined above, is to be used, with the exception of the fumigation procedure, when the detention is for dead insect infestation only. As previously stated this procedure is not to be accepted when the detention is for insect damaged and/or moldy coffee beans.
Reconditioning of Biologicals
Unlicensed biologicals or biologicals without an effective IND which were refused admission are not subject to reconditioning except in the instances where the intended use of the product is changed to render the product a non-biological, non-drug product, and is so
reflected in the associated labeling. Center for Biologics Evaluation and Research (CBER) concurrence with any reconditioning application for a biological product is required.
EXHIBITS
9-2 Form FD-766 (Front) 9-2 Form FD-766 (Back)