NAC585.580. Master record of drugs.

To ensure uniformity from batch to batch, a master record for each drug and each batch of drug must be prepared, dated and signed or initialed by a competent and responsible person and must be independently checked, reconciled, dated and signed or initialed by a second competent and responsible person. The master record must include:

     1. The name of the drug, a description of the dosage form and a specimen or copy of each label and all other labeling associated with the retail or bulk unit, including copies of the labeling signed or initialed and dated by the person responsible for its approval.

     2. The name and weight or measure of each active ingredient per dosage unit or per unit of weight or measure of the finished drug and statement of the total weight or measure of any dosage unit.

     3. A complete list of ingredients, designated by names or codes sufficiently specific to indicate any special characteristic of quality, and the following information:

     (a) An accurate statement of the weight or measure of each ingredient, regardless of whether it appears in the finished product, except that reasonable variations are permitted in the amount of components necessary in the preparation in dosage form if provisions for such variations are included in the master record;

     (b) An appropriate statement concerning any calculated excess of an ingredient;

     (c) An appropriate statement of theoretical weight or measure at various stages of processing; and

     (d) A statement of the theoretical yield.

     4. A description of the containers and closures and the packaging and finishing materials.

     5. The manufacturing and control instructions, procedures, specifications, special notations and precautions to be followed.

     [Comm’r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 6.1-6.1.5, eff. 5-15-78]