21 CFR § 225.42 - Components.

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§ 225.42 Components.

(a) A medicated feed, in addition to providing nutrients, is a vehicle for the administration of a drug, or drugs, to animals. To ensure proper safety and effectiveness, such medicated feeds must contain the labeled amounts of drugs. It is necessary that adequate procedures be established for the receipt, storage, and inventory control for all such drugs to aid in assuring their identity, strength, quality, and purity when incorporated into products.

(b) The receipt, storage, and inventory of drugs, including undiluted drug components, medicated premixes, and semiprocessed (i.e., intermediate premixes, inplant premixes and concentrates) intermediate mixes containing drugs, which are used in the manufacture and processing of medicated feeds shall conform to the following:

(1) Incoming shipments of drugs shall be visually examined for identity and damage. Drugs which have been subjected to conditions which may have adversely affected their identity, strength, quality, or purity shall not be accepted for use.

(2) Packaged drugs in the storage areas shall be stored in their original closed containers.

(3) Bulk drugs shall be identified and stored in a manner such that their identity, strength, quality, and purity will be maintained.

(4) Drugs in the mixing areas shall be properly identified, stored, handled, and controlled to maintain their integrity and identity. Sufficient space shall be provided for the location of each drug.

(5) A receipt record shall be prepared and maintained for each lot of drug received. The receipt record shall accurately indicate the identity and quantity of the drug, the name of the supplier, the supplier's lot number or an identifying number assigned by the feed manufacturer upon receipt which relates to the particular shipment, the date of receipt, the condition of the drug when received, and the return of any damaged drugs.

(6) A daily inventory record for each drug used shall be maintained and shall list by manufacturer's lot number or the feed manufacturer's shipment identification number at least the following information:

(i) The quantity of drug on hand at the beginning and end of the work day (the beginning amount being the same as the previous day's closing inventory if this amount has been established to be correct); the quantity shall be determined by weighing, counting, or measuring, as appropriate.

(ii) The amount of each drug used, sold, or otherwise disposed of.

(iii) The batches or production runs of medicated feed in which each drug was used.

(iv) When the drug is used in the preparation of a semiprocessed intermediate mix intended for use in the manufacture of medicated feed, any additional information which may be required for the purpose of paragraph (b)(7) of this section.

(v) Action taken to reconcile any discrepancies in the daily inventory record.

(7) Drug inventory shall be maintained of each lot or shipment of drug by means of a daily comparison of the actual amount of drug used with the theoretical drug usage in terms of the semiprocessed, intermediate and finished medicated feeds manufactured. Any significant discrepancy shall be investigated and corrective action taken. The medicated feed(s) remaining on the premises which are affected by this discrepancy shall be detained until the discrepancy is reconciled.

(8) All records required by this section shall be maintained on the premises for at least one year after complete use of a drug component of a specific lot number or feed manufacturer's shipment identification number.