§ 82-520 — Records

Sec. 82-520. - Records.

(a) Maintenance. Records shall be made, concurrently with the performance, of each step in the processing and distribution of products in such a manner that at any time successive steps in the processing and distribution of any lot may be traced by an inspector. Such records shall be legible and indelible, shall identify the person immediately responsible, shall include dates of the various steps, and be as detailed as necessary for clear understanding of each step by one experienced in the processing of products. (b) Retention generally. Records shall be retained for such interval beyond the expiration date as is necessary for the individual product, to permit the return of any clinical report of unfavorable reactions. The retention period shall be no less than five years after the records of processing have been completed or six months after the latest expiration date for the individual product, whichever represents a later date. (c) Records of recall. Complete records shall be maintained pertaining to the recall from distribution of any product upon notification by the director of the department of health, to recall for failure to conform with the standards prescribed in the regulations of this article, because of deterioration of the product or for any other factor by reason of which the distribution of the product would constitute a danger to health. (d) Suspension of requirement for retention. The director of the department of health may authorize the suspension of the requirement to retain records of a specific processing step upon a showing that such records no longer have significance for the purposes for which they were made, provided, that a summary of such records shall be retained. (e) Sterilization of equipment and supplies. Records relating to the mode of sterilization, date, duration, temperature and other conditions relating to each sterilization of equipment and supplies used in the processing of products shall be made by means of automatic recording devices or by means of a system of recording which gives equivalent assurance of the accuracy and reliability of the record. Such records shall be maintained in a manner that permits an identification of the product with the particular process to which the sterilization relates. (f) Animal necropsy records. A necropsy record shall be kept on each animal from which a biological product has been obtained and which dies or is sacrificed while being so used. (g) Records in case of divided processing responsibility. If two or more establishments participate in the processing of a product, the records of each such establishment must show plainly the degree of its responsibility. In addition, each participating processor shall furnish to the processor who prepares the product in final form for sale, barter or exchange, a copy of all records relating to the processing operations performed by such participating processor insofar as they concern the safety, purity and potency of the lots of the product involved, and the processor who prepares the product in final form shall retain a complete record of all the processing operations relating to the product.

(Code 1956, § 29-104)