FDA outlines rules for ‘portions’ of official samples in draft Q&A guidance
The US Food and Drug Administration (FDA) on Friday issued a draft guidance in a question-and-answer format clarifying the regulatory requirements for collecting and providing portions of official samples of drugs, foods or cosmetics under section 702(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).The 12-page draft guidance contains 10 questions and answers providing an overview of FDA’s interpretation of its regulations governing the collection and provision of portions of official samples.
The guidance states that section 702 “authorizes FDA to conduct examinations and investigations and to collect samples,” while section 702(b) requires FDA to “upon request, provide a part of such official sample for examination or analysis by any person named on the label of the article, or the owner thereof, or his attorney or agent.” This section also authorizes FDA to establish “reasonable exceptions from, and impose such reasonable terms and conditions” related to administering this provision of the regulation, which are detailed at 21 CRF 2.10.
The guidance specifies that under 21 CFR 2.10(c), a portion of a sample must be provided to its owner, if available, after FDA has completed all analysis to determine whether the product has been adulterated or misbranded and it has “reserved an amount of the article it estimates to be adequate for use as an exhibit in the trial of any case that may arise based on the sample.” If any portion of the sample remains available, the agency must provide it to the owner upon written request, so long as no other exception applies.
The guidance also addresses what constitutes a 702(b) portion, what constitutes an official sample, some expectations for collection requirements and when FDA must collect a 702(b) portion.
For example, the amount of a sample that remains for providing a 702(b) portion “depends on the amount of sample collected, the amount of the sample used for the analysis, and the amount of the sample reserved for trial. The amount reserved for trial is what FDA estimates to be adequate for use as exhibits in the trial of any case that may arise under the FD&C Act based on the sample and will be determined at FDA’s discretion.”
It further specifies that FDA should retain 702(b) portions until authorized to destroy them. The agency is authorized under 21 CFR 2.10(e) to destroy a sample when the agency determines that no analyses of the sample will be made, the sample is perishable or the sample is decomposed or otherwise unfit for analysis.
The owner of the product should make requests to the FDA division of the officer or the employee who collected the sample. Requests must be in writing and sent through electronic mail or postal mail and accompanied by proof of ownership of the sample or demonstrate the authority to receive the sample on behalf of the owner.
The request should also include the sample’s lot and serial number, the model number and specify the amount of the desired sample. The owner should also provide a copy of the Form FDA 484 Receipt for Samples issued by the collecting officer or the employee.
In responding to requests, the FDA employee who collected the sample may consult with the FDA’s Office of Regulatory Affairs or the FDA’s Office of Chief Counsel.
Comments on the draft guidance should be submitted to the public docket by 22 February 2022 for consideration.
Guidance