§ 213.82 Receipt and storage of incoming designated medical gases.

(a)(1) Upon receipt of each shipment of each incoming designated medical gas, the firm shall either perform full compendial testing on the gas and record the results or verify and record that a signed certificate of analysis from the supplier accompanies each different designated medical gas in a shipment. The certificate of analysis shall include the following: (i) Supplier's name; (ii) Name of the incoming designated medical gas; (iii) Lot number or other unique identification number; (iv) Actual analytical result obtained for strength, as well as the results of other tests performed; (v) Identification of the test method(s) used for analysis; (vi) New drug application and/or new animal drug application number of the incoming designated medical gas; and (vii) Supplier representative's signature and the date of signature. (2) If the incoming designated medical gas is obtained from a supplier other than the original manufacturer, the shipment shall also include complete information from the original manufacturer's certificate of analysis. The firm shall establish and maintain a program to ensure the reliability of the supplier's capabilities through appropriate assessment and testing procedures. (b) An identity test shall be performed upon receipt of the incoming designated medical gas.