Misbranded drugs.

17.1 For raw materials and packaging materials. - They shall include-(a) the designated name and internal code reference; (b) reference, if any, to a pharmacopoeial monograph; (c) qualitative and quantitative requirements with acceptance limits; (d) name and address of manufacturer or supplier and original manufacturer of the material; (e) specimen of printed material; (f) directions for sampling and testing or reference to procedures; (g) storage conditions; and (h) maximum period of storage before re-testing. 17.2 For product containers and closures:– 17.2.1 All containers and closures intended for use shall comply with the pharmacopoeial requirements. Suitable validt. test methods, sample sizes, specifications, cleaning procedure and sterilization procedure, wherever indicated, shall be strictly followed to ensure that these are not reactive, additive, absorptive, or leach to an extent that significantly affects the quality or purity of the drug. No second hand or used containers and closures shall be used. 17.2.2 Whenever bottles are being used, the written schedule of cleaning shall be laid down and followed. Where bottles are not dried after washing, they should be rinsed with de-ionised water or distilled water, as the case may be.