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Pili 78 -244

[PUBLIC LAW 244—78TH CONGRESS)
(CAAPTER 77-2D SEBbion)

(H. R. 149)

AN ACT To fix a reasonable definition and standard of identity of certain dry milk solids.

Be it enacted by ihe Senate and House of Reprerentutives of the United States of America in Congress ussembled, That for the purposes of the Federal Food, Drng, and Cosmetic Act of June 26, 1938 (ch. 675, sec. 1, 52 Stat. 1040), nonfat dry milk solids or defatted milk solids is the procluct resulting from the removal of fat and water froin milk, and contains the lactose, milk proteins, and milk minerals in the same relative proportions as in the fresh milk from which inade. It coliains not over 5 per centum by weight of moisture. The fat со nt is not over 11/2 per centum by weight unless otherwise indicated.

The term “milk”, when used herein, means sweet milk of cuws. Approved March 2, 1944.

79TH CONGRESS

1st SESSION

H. R. 3266

IN THE HOUSE OF REPRESENTATIVES

May 18, 1945 Mr. Lea introduced the following bill; which was referred to the Com

mittee on Interstate and Foreign Commerce

A BILL

1

To amend the Federal Food, Drug, and Cosmetic Act of June

25, 1938, as amended, by providing for the certification of batches of drugs composed wholly or partly of any kind of penicillin or any derivative thereof, and for other purposes.

Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 3 That section 301 (i) of the Federal Food, Drug, and Cos4 metic Act of June 25, 1938 (21 U. S. C. 301 and the 5 following), as amended, is amended by inserting "507"

6 after “506,”.

7

SEC. 2. Section 502 of such Act, as amended, is amended

8 by adding a new paragraph at the end thereof, as follows:

9

“(1) If it is, or purports to be, or is represented as a

2

1 drug composed wholly or partly of any kind of penicillin

2 or any derivative thereof, unless (A) it is from a batch with

3 respect to which a certificate or release has been issued pur4 suant to section 507, and (B) such certificate or release

5 is in effect with respect to such drug: Provided, That this

6 paragraph shall not apply to any drug or class of drugs

7 exempted by regulations promulgated under section 507 (c)

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9

SEC. 33. Chapter V of such Act, as amended, is amended

10 by adding a new section at the end thereof, as follows:

11

“CERTIFICATION OF DRUGS CONTAINING PENICILLIN

12

"SEC. 507. (a) The Federal Security Administrator, pursuant to regulations promulgated by him, shall provide

13

14 for the certification of batches of drugs composed wholly or

15 partly of any kind of penicillin or any derivative thereof. 16 A batch of any such drug shall be certified if such drug has 17 such characteristics of identity and such batch has such 18 characteristics of strength, quality, and purity, as the Ad

19 ministrator prescribes in such regulations as necessary to

20 adequately insure safety and efficacy of use, but shall not

21 otherwise be certified. Prior to the effective date of such

22 regulations the Administrator, in lieu of certification, shall 23 issue a release for any batch which, in his judgment, may 24 be released without risk as to the safety and efficacy of its

use. Such release shall prescribe the date of its expiration

25

3

1 and other conditions under which it shall cease to be effec

5

6

2 tive as to such batch and as to portions thereof. 3 “(b) Regulations providing for such certifications shall 4 contain such provisions as are necessary to carry out the

purposes of this section, including provisions prescribing

(1) standards of identity and of strength, quality, and 7 purity; (2) tests and methods of assay to determine com8 pliance with such standards; (3) effective periods for 9 certificates, and other conditions under which they shall

cease to be effective as to certified batches and as to por11 tions thereof; (4) administration and procedure; and (5) 12 such fees, specified in such regulations, as are necessary to 13 provide, equip, and maintain an adequate certification serv14 ice. Such regulations shall prescribe only such tests and 15 methods of assay as will provide for certification or rejection 16 within the shortest time consistent with the purposes of this

10

17 section.

21

18 “(c) Whenever in the judgment of the Administrator 19 the requirements of this section and of section 502 (1) 20 with respect to any drug or class of drugs are not necessary

to insure safety and efficacy of use, the Administrator shall 22 promulgate regulations exempting such drug or class of 23 drugs from such requirements.

“ (d) The Administrator shall promulgate regulations 25 exempting from any requirement of this section and of section

24

4

1 502 (1), (1) drugs which are to be stored, processed, 2 labeled, or repackaged at establishments other than those

3 where manufactured, on condition that such drugs comply 4 with all such requirements upon removal from such estab5 lishments; (2) drugs which conform to applicable stand6 ards of identity, strength, quality, and purity prescribed by 7 these regulations and are intended for use in manufacturing 8 other drugs; and (3) drugs which are intended solely for 9 investigational use by experts qualified by scientific training 10 and experience to investigate the safety and efficacy of drugs.

“(e) No drug which is subject to section 507 shall be 12 deemed to be subject to any provision of section 505. Com13 pliance of any drug subject to section 502 (1) or 507 with 14 sections 501 (b) and 502 (g) shall be determined by the 15 application of the standards of strength, quality, and purity,

11

16 the tests and methods of assay, and the requirements of

19

17 packaging and labeling, respectively, prescribed by regula18 tions promulgated under section 507.

“ (f) Any interested person may file with the Adminis20

trator a petition proposing the issuance, amendment, or repeal 21 of any regulation contemplated by this section. The peti22 tion shall set forth the proposal in general terms and shall 23 state reasonable grounds therefor. The Administrator shall 24 give public notice of the proposal and an opportunity for 25 all interested persons to present their views thereon, orally

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