152 Subpart G—Packaging and Labeling Control

§ 211.115 21 CFR Ch. I (4–1–11 Edition)

required to be sterile, shall be estab- contents shall be stored separately lished and followed. with suitable identification. Access to (b) Appropriate written procedures, the storage area shall be limited to au- designed to prevent microbiological thorized personnel. contamination of drug products pur- (e) Obsolete and outdated labels, la- porting to be sterile, shall be estab- beling, and other packaging materials lished and followed. Such procedures shall be destroyed. shall include validation of all aseptic (f) Use of gang-printed labeling for and sterilization processes. different drug products, or different strengths or net contents of the same [43 FR 45077, Sept. 29, 1978, as amended at 73 drug product, is prohibited unless the FR 51932, Sept. 8, 2008] labeling from gang-printed sheets is § 211.115 Reprocessing. adequately differentiated by size, shape, or color. (a) Written procedures shall be estab- (g) If cut labeling is used, packaging lished and followed prescribing a sys- and labeling operations shall include tem for reprocessing batches that do one of the following special control not conform to standards or specifica- procedures: tions and the steps to be taken to in- (1) Dedication of labeling and pack- sure that the reprocessed batches will aging lines to each different strength conform with all established standards, of each different drug product; specifications, and characteristics. (2) Use of appropriate electronic or (b) Reprocessing shall not be per- electromechanical equipment to con- formed without the review and ap- duct a 100-percent examination for cor- proval of the quality control unit. rect labeling during or after comple- tion of finishing operations; or Subpart G—Packaging and (3) Use of visual inspection to con- Labeling Control duct a 100-percent examination for correct labeling during or after comple- § 211.122 Materials examination and tion of finishing operations for hand- usage criteria. applied labeling. Such examination (a) There shall be written procedures shall be performed by one person and describing in sufficient detail the re- independently verified by a second per- ceipt, identification, storage, handling, son. sampling, examination, and/or testing (h) Printing devices on, or associated of labeling and packaging materials; with, manufacturing lines used to im- such written procedures shall be fol- print labeling upon the drug product lowed. Labeling and packaging mate- unit label or case shall be monitored to rials shall be representatively sampled, assure that all imprinting conforms to and examined or tested upon receipt the print specified in the batch produc- and before use in packaging or labeling tion record. of a drug product. [43 FR 45077, Sept. 29, 1978, as amended at 58 (b) Any labeling or packaging mate- FR 41353, Aug. 3, 1993] rials meeting appropriate written specifications may be approved and re- § 211.125 Labeling issuance. leased for use. Any labeling or pack- (a) Strict control shall be exercised aging materials that do not meet such over labeling issued for use in drug specifications shall be rejected to pre- product labeling operations. vent their use in operations for which (b) Labeling materials issued for a they are unsuitable. batch shall be carefully examined for (c) Records shall be maintained for identity and conformity to the labeling each shipment received of each dif- specified in the master or batch pro- ferent labeling and packaging material duction records. indicating receipt, examination or (c) Procedures shall be used to rec- testing, and whether accepted or re- oncile the quantities of labeling issued, jected. used, and returned, and shall require (d) Labels and other labeling mate- evaluation of discrepancies found be- rials for each different drug product, tween the quantity of drug product fin- strength, dosage form, or quantity of ished and the quantity of labeling

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issued when such discrepancies are out- (e) Inspection of the packaging and side narrow preset limits based on his- labeling facilities immediately before torical operating data. Such discrep- use to assure that all drug products ancies shall be investigated in accord- have been removed from previous oper- ance with § 211.192. Labeling reconcili- ations. Inspection shall also be made to ation is waived for cut or roll labeling assure that packaging and labeling ma- if a 100-percent examination for correct terials not suitable for subsequent op- labeling is performed in accordance erations have been removed. Results of with § 211.122(g)(2). inspection shall be documented in the (d) All excess labeling bearing lot or batch production records. control numbers shall be destroyed. [43 FR 45077, Sept. 29, 1978, as amended at 58 (e) Returned labeling shall be main- FR 41354, Aug. 3, 1993] tained and stored in a manner to prevent mixups and provide proper identi- § 211.132 Tamper-evident packaging fication. requirements for over-the-counter (f) Procedures shall be written de- (OTC) human drug products. scribing in sufficient detail the control (a) General. The Food and Drug Ad- procedures employed for the issuance ministration has the authority under of labeling; such written procedures the Federal Food, Drug, and Cosmetic shall be followed. Act (the act) to establish a uniform na- tional requirement for tamper-evident [43 FR 45077, Sept. 29, 1978, as amended at 58 packaging of OTC drug products that FR 41354, Aug. 3, 1993] will improve the security of OTC drug packaging and help assure the safety § 211.130 Packaging and labeling operations. and effectiveness of OTC drug products. An OTC drug product (except a der- There shall be written procedures de- matological, dentifrice, insulin, or loz- signed to assure that correct labels, la- enge product) for retail sale that is not beling, and packaging materials are packaged in a tamper-resistant pack- used for drug products; such written age or that is not properly labeled procedures shall be followed. These under this section is adulterated under procedures shall incorporate the fol- section 501 of the act or misbranded lowing features: under section 502 of the act, or both. (a) Prevention of mixups and cross- (b) Requirements for tamper-evident contamination by physical or spatial package. (1) Each manufacturer and separation from operations on other packer who packages an OTC drug drug products. product (except a dermatological, den- (b) Identification and handling of tifrice, insulin, or lozenge product) for filled drug product containers that are retail sale shall package the product in set aside and held in unlabeled condi- a tamper-evident package, if this prod- tion for future labeling operations to uct is accessible to the public while preclude mislabeling of individual con- held for sale. A tamper-evident pack- tainers, lots, or portions of lots. Identi- age is one having one or more indica- fication need not be applied to each in- tors or barriers to entry which, if dividual container but shall be suffi- breached or missing, can reasonably be cient to determine name, strength, expected to provide visible evidence to quantity of contents, and lot or control consumers that tampering has oc- number of each container. curred. To reduce the likelihood of suc- (c) Identification of the drug product cessful tampering and to increase the with a lot or control number that per- likelihood that consumers will discover mits determination of the history of if a product has been tampered with, the manufacture and control of the the package is required to be distinc- batch. tive by design or by the use of one or (d) Examination of packaging and la- more indicators or barriers to entry beling materials for suitability and that employ an identifying char- correctness before packaging oper- acteristic (e.g., a pattern, name, reg- ations, and documentation of such ex- istered trademark, logo, or picture). amination in the batch production For purposes of this section, the term record. ‘‘distinctive by design’’ means the

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