Section 22
SEC. 22. (a) The Secretary, pursuant to regulations promulgated by him shall provide for the certification of batches of drugs composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other anti-biotic drug, or any derivative thereof. A batch of such drug shall be certified if such drug has such characteristics of identity, strength, quality and purity, as the Secretary prescribes in such regulations as necessary to adequately insure safety and efficacy of use, but shall not otherwise be certified. Prior to the effective date of such regulations the Secretary, in lieu of certification, shall issue a release for any batch which, in his judgment, may be released without risk as to the safety and efficacy of its use. Such release shall prescribe the date of its expiration and other conditions under which it shall cease to be effective as to such batch and as to portions thereof. For purposes of this section and of Section nineteen (k), the term "anti-biotic drug" means any drug intended for use by man containing any quantity of any chemical substance which is produced by micro-organism and which has the capacity to inhibit or destroy micro-organism in dilute solution (including the chemically synthesized equivalent of any such substance). (b) Whenever in the judgment of the Secretary, the requirements of this section and of Section nineteen (k) with respect to any drug or class of drugs are not necessary to insure safety and efficacy of use, the Secretary shall promulgate regulations exempting such drug or class of drugs from such requirements. (c) The Secretary shall promulgate regulations exempting from any requirement of this section and of Section nineteen (k), (1) drugs which are to be stored, processed labeled, or repacked at establishments other than those where manufactured, on condition that such drugs comply with all such requirements upon removal from such establishments; (2) drugs which conform to applicable standards of identity, strength, quality, and purity prescribed by these regulations and are intended for use in manufacturing other drugs; and (3) drugs which are intended for investigational use by experts qualified by scientific training and experience to investigate the safety and efficacy of drugs.