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VOLUME 16

onal

O y v f jE O

NUMBER 208

Washington, Thursday, October 25, 195J
it appears, the words with sulfon amides or with probenecid, as the case Chapter I Food and Drug Adminis may be, in juxtaposition with such name.
tration, Federal Security Agency 3. Part 146 is amended by adding the following new section:
P art 141 T e s t s and M ethods of Assa y for A n tibio tic and A n tibio tic -C on
146.215 Aureomycin w ith vasocon taining D rugs strictor aureom ycin hydrochloride w ith vasoconstrictor ; aureom ycin w it h ____
P art 146C ertification of B atches of aureom ycin hydrochloride w it h _____
An tibio tic and An tibio tic -C ontaining th e blan k being filled in w ith th e com
D rugs m on or usual nam e o f th e vasoconstric pen icillin tablets and aureomycin w it h to r a Standards o f i d e n t i t y , vasoconstrictor strength, quality, and purity. Aureo mycin with vasoconstrictor is a dry mix By virtue of the authority vested in the ture of crystalline aureomycin and a Federal Security Administrator by the suitable vasoconstrictor, with or without provisions of section 507 of the Federal suitable and harmless diluents, preserva Food, Drug, and Cosmetic Act 52 Stat.
tives, colorings, and flavorings, or it is 1040, 1055, as amended by 59 Stat. 463, a packaged combination of one immedi 61 Stat. 11, 63 Stat. 409; 21 U. S. C. 357, ate container of crystalline aureomycin the regulations for tests and methods of with or without suitable and harmless assay for antibiotic and antibiotic-con diluents, preservatives, colorings, and taining drugs 21 CFR, 1950 Supp., 141
flavorings and one immediate container and certification of batches of antibiotic of a solution of a suitable vasoconstric and antibiotic-containing drugs 21 CFR, tor. The aureomycin is of such quantity 1950 Supp., 146; 16 F. R. 3647 are th at when dissolved as directed the amended as indicated below:
potency of such solution is not less than 1. Part 141 is amended by adding the 1 milligram per milliliter and maintains following new section:
its labeled potency after it has been kept 141.215 Aureomycin with vasocon for 4 days in a refrigerator. Such solu strictor a Potency. Proceed as di tion has a pH of 3.1, 0.2. The moisture rected in 141.201 a.
content of the dry mixture is not more b M oisture. Proceed as directed in than 5.0 percent. The aureomycin used 141.5 a.
conforms to the requirements of 146.201
a , except subparagraphs 2, 4, and 2a. In 146.27 Penicillin tablets, the first sentence of paragraph a Stand 5 of that paragraph. Each other sub ards o f identity etc., is changed to read:
stance used, if its name is recognized in the U. S. P. or N. F., conforms to the Penicillin tablets are tablets composed of sodium penicillin, calcium penicillin, standards prescribed therefor by such official compendium.
potassium penicillin, crystalline penicil lin O, or procaine penicillin, with or b Packaging. Each immediate con tainer shall be a tight container as de without two or more suitable sulfona mides or probenecid and with or without fined by the U. S. P., and shall be of the addition of one or more suitable and such composition as will not cause any change in the strength, quality, or purity harmless buffer substances, diluents, col orings, and flavorings.
of the contents beyond any limit there for in applicable standards, except that b. Section 146.27 c 1 iii is minor changes so caused which are nor amended to read as follows:
mal and unavoidable in good packaging, c Labeling. 1
storage, and distribution practice shall iii If the batch contains sulfon be disregarded.
amides or probenecid, the name and c Labeling. Each package shall quantity of each such substance used in bear on its label or labeling, as herein making the batch;
after indicated, the following:
c. Section 146.27 c 3 is amended 1
On the outside wrapper or con to read as follows:
tainer and on the immediate container 3
On the label and labeling, if sul of the aureomycin:
i The batch mark.
fonamides or probenecid is present, after the name penicillin tablets, wherever Continued on p. 10849

TITLE 21 FOOD AND DRUGS

CONTENTS
Agriculture Department S ee Production and Marketing Ad ministration.
Alien Property, Office of Notices:
Vesting orders, etc.:
Beckmann, Carolina Carrie.
Beckmann, Elizabeth M., et a l __________________
Boos, Gabriel_______________
Ducker, Morris____________
Kipp, Fred_________
Kuether, Klaus, et al___ .___
Pennsylvania and Rev. Joseph Enderle____________
Sakayeda, Toshiyo__________
Sassoon, Rahmo S _________
Schuette, Mrs. Lydia_______
Sieh, Emil J _______________
Stien, Peter_________________
Tietz, Bertha_______________
Von Platen, E g g e r t Karl Julius, et al______________
Coast Guard Rules and regulations:
Transportation or storage of explosives or other danger ous articles or substances, and combustible liquids on board vessels; inflammable liquids_____________________
Waivers of navigation and ves sel inspection laws and regu lations; able seamen em ployed on merchant vessels other than Great Lakes ves sels 2 documents_________
Commerce Department S ee International Trade, Office o f; National Production Au thority; National Shipping Au thority.
Defense M obilization, Office of Notices:
Determination and certification of a critical defense housing area:
Aberdeen, Md., area________
Alamogordo, N. Mex., area__
Bainbridge-Elkton, Md., area.
Dover, Del., area____________
Hartford, Conn___________
Mineral Wells-Weatherford, Tex., area________________
Rapid City-Sturgis, S. Dak., area_____________________
Sidney, Nebr., area__ _______
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