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Related post: storage generally occur shortly after beginning distribution. Various time periods were recommended as alternatives. Several comments suggested a retention period of 2 years after the batch was approved for marketing. The Commissioner finds that these records must be available for review for a reasonable time period beyond the expiration date of the products covered in the records to provide an opportunity for appropriate followup of any complaints or other adverse reports received during the entire marketing period. In reconsidering the extent of such retention period in light of the comments, however, the Commissioner has determined that a 1-year period following the expiration date will generally be adequate to assure that the records will be available for review if necessary. In the case of certain OTC drug products not being required to bear an expiration date because they meet the criteria for exemption under 211.137, the record retention period is 3 years after distribution of the batch. This 3-year period is considered appropriate because the exemption is based on an assumption that such products will be used within 3 years after manufacture. Therefore, record retention for 3 years after distribution should be adequate to cover the time period during which records are most likely to be needed. The Commissioner recognizes that these final regulations will require retention of records beyond that currently required in the CGMP regulations. The CGMP regulations require the retention of certain records, e.g., batch production and control records, for time periods that are based on the distribution of the lot or, where applicable, the expiration date of the batch. The current regulations do not clearly specify the record retention period for other records. For some firms, the retention period for records will not change as a result of this regulation, as their practice is being incorporated in these regulations. In other cases, however, these regulations will require retention of records for a period of time longer than the minimum retention period specified in previous CGMP regulations. With specific regard to physical space for the storage of records, the Commissioner advises that the regulations do not generally require retention of original records, and that retention of suitable true copies in other forms such as microfilm is permitted. The Commissioner believes that, in keeping with modern business practices, there are many record retention systems that would fulfill the intent of the record retention provisions. Section 211.180(d) of the final regulations specifically provides for this flexibility. 424. One comment said 211.180 should be deleted because section 703 of the act prescribes the maintenance of certain records that show the movement of articles in interstate commerce and does not mention the retention of records as described in 211.180. The Commissioner disagrees with this comment. Section 703 of the act permits FDA access to records of interstate shipment in the possession of carriers (i.e., transportation companies) or other persons receiving or holding food, drugs, devices, or cosmetics in interstate commerce. The provisions of section 703 do not apply to the manufacturers of drug products insofar as records of production are concerned. 425. One comment suggested that retention of records for components that have an indefinite stability or components that are used only occasionally to produce batches of drug products be excluded from 211.180(b). The Commissioner rejects this suggestion. The retention period is related to the expiration dates of the batches of drug products containing that batch of the component in order to assure that the records would be available for review during the marketing of the drug products and for a reasonable period thereafter. The Commissioner seriously questions whether any drug product can be considered indefinitely stable or would in fact carry an expiration date that would require record retention for an extraordinarily long time. Finally, the Commissioner notes that because the manufacturer has discretion to establish an expiration date that is less than the actual stability of the drug product, the manufacturer also has reasonable control over the periods during which he must retain records. 426. One comment said 211.180(b) is overly inclusive and should be reworded to include only those components that come in actual contact with the drug product. The Commissioner is unclear on the use of the word "component" in this comment. The definition of "component" appearing in the CGMP regulations would only include ingredients intended for use in the manufacture of a drug product, including those that may not appear in the final product. Section 211.180(b) limits records to components actually incorporated in the drug product. Thus, it seems obvious that the regulations only apply to components "that come into actual contact with the drug product" as requested in this comment. Therefore, the Commissioner cannot agree that the requirement as proposed is too extensive, and he sees no justification for revisions in the language in this paragraph. 427. Some comments suggested that reference to drug product containers and closures be deleted because these items are not subject to deterioration. One comment suggested that the requirement be retained for parenterals only. The Commissioner does not agree that reference to container/closure record retention should be deleted because they are not subject to deterioration. The Commissioner is aware that some container/closure systems are subject to deterioration and there are other possible problems with containers and closures that may adversely affect the drug product. The purpose and intent of recordkeeping requirements is to be able to trace the complete history of a batch and thereby enable a firm and FDA to investigate fully any problems that may arise with either the product, the container/closure system, or both. Complete records would also make possible a determination of whether or not other batches or other drug products are or could be involved with the same problem. The failure to have these records available for any investigation could prevent the resolution of an undesirable condition. Therefore, the Commissioner is retaining this requirement to include all drug product containers and closures. 428. A comment on 211.180(b) was submitted regarding the retention of records for compressed medical gases. The comment, which assumed that expiration dating would not be required for compressed medical gases, requested a retention period to be some logical and meaningful period. The Commissioner finds that there is no justification for Buy Keftab excluding retention of records required for compressed medical gases under this paragraph. The Commissioner has also decided to require expiration dating for medical gases. 428a. Several comments objected to reference to recordkeeping and record inspection requirements in proposed 211.180 (c) and (d) insofar as they apply to over-the-counter (OTC) drugs and to "not new" drugs. These comments pointed out that section 704(a) of the act authorizes inspection of records regarding prescription drugs only and inspection of records regarding research data only on "new drugs" subject to section 505 of the act. One comment cited extensively from the legislative history of section 704 of the act indicating a congressional intent to limit the scope of inspection granted to FDA. The Commissioner has reviewed the legislative history of the 1953 amendments (Pub. L. 83-217), which originally enacted section 704(a) of the act, as well as the amendments contained in the Drug Amendments of 1962 (Pub. L. 87- 781 (1961)), which extended FDA's authority to review records for prescription drugs under the mandatory inspection authority of section 704 of the act. He finds that Congress did not include in the scope of the inspection authority under section 704 of the act (and its concomitant enforcement section under section 301(f) of the act) authority to inspect records regarding the manufacture of OTC drug products or research data on prescription drugs that are not "new drugs" as defined in section 201(p) of the act. The Commissioner also finds, however, that section 704 of the act does not exhaust the varieties of inspections that FDA may be authorized to make regarding such drug products. Manufacture of any drug product without compliance with current good manufacturing practices renders the product adulterated, a prohibited act under section 301(b) of the act and a Federal crime under section 303 of the act.
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