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FEDERAL
VOLUME 18

O / v fn D

NUMBER 226

Washington, Thursday, November 19, 1953

TITLE 21 FOOD AND DRUGS
Chapter 1 Food and Drag Adminis tration, Department of Health, Education, and Welfare P art 141 T ests and M ethods o p A ss a y for A n t ib io t ic and A n t ib io t ic -C o n
t a in in g D rugs P ar t 146 C e r t if ic a t io n of B atch es of A n t ib io t ic and A n t ib io t ic -C o n t a in in g D rugs m isc e lla n e o u s am e nd m e nts
b.
Paragraph a is further amended CONTENTS
by changing the word chlortetracy Agriculture Department cline in the second sentence to read See Production and Marketing Ad chlortetracycline or tetracycline .
ministration.
3. In 141.207, the section headnote and paragraph a are amended to Air Force Department read:
Rules and regulations:
Officers Reserve; Air Force R e 141.207 Chlortetracycline tablets;
serve Officers Training Corps;
tetracycline tablets a Potency. Pro enlistment in the Regular Air ceed as directed in 141.204 a . The Force; miscellaneous amendaverage potency of the drug is satisfac ments ___________ _________
tory if it contains not less than 85 per cent of the number of milligrams it is Armed Services Patent Advi represented to contain.
sory Board 4. Part 141 is amended by adding the Notices:
Organization and functions----following new section:

By virtue of the authority vested in the Secretary by the provisions of the Fed eral Food, Drug, and Cosmetic Act sec.
141.218 Tetracycline hydrochlo 507, 59 Stat. 463, as amended by 61 Stat.
11, 63 Stat. 409, 67 Stat. 389; sec. 701, 52 ride a Potency. Using the tetra Stat. 1055; 21 U. S. C. 357, 371; 67 Stat. cycline hydrochloride working standard 18, the regulations for tests and meth as a standard of comparison, proceed as ods of assay for antibiotic and antibioticdirected in 141.201 a , except in the containing drugs 21 CFR, 1952 Supp., preparation of the standard curve for Part 141; 18 F. R. 3533, 5366 and certifi the turbidimetric assay proceed as cation of batches of antibiotic and anti follows:
biotic-containing drugs 21 CFR, 1952
1 Dilute the stock solution to con Supp., Part 146; 18 F. R. 2337, 3533, 5366, tain 0.4 microgram per milliliter in lieu 5440, 5591 are amended as indicated o f 0.1 microgram per milliliter.
2 Prepare 10 tubes each o f the mini below:
1.
In 141.204, the section headnotemum 0.04 microgram per milliliter and and paragraph a are amended to read: maximum 0.4 microgram per milliliter 141.204 Chlortetracycline capsules; concentrations diluted for the standard tetracycline capsules a P o t e n c y . curve and use these solutions to adjust Using 1 capsule of 250 milligrams or 5 the photoelectric colorimeter:
3 Use the 0.24 microgram per milli capsules of 50 milligrams for each assay liter concentration of the standard curve and 500 milliliters of water in the blender, proceed as directed in 141.203 as the reference point.
4 Dilute the sample to be tested to a if it is chlortetracycline, or 141.218 contain an estimated concentration of a if it is tetracycline. The average 0.24 microgram per milliliter in lieu of potency of the drug is satisfactory if it 0.06 microgram per milliliter.
contains not less than -85 percent of the b Sterility and toxicity. Proceed as number of milligrams it is represented to directed in 141.201 b and c.
contain.
c Pyrogens. Proceed as directed in 2a. In 141.205, the section headnote 141.3, using as a test dose 1.0 milliliter per kilogram of an aqueous solution con and the first sentence of paragraph a taining 500 micrograms per milliliter.
are amended to read:
d Histamine, moisture, pH, and 141.205 Chlortetracycline powder;
tetracycline powder a
Potency. crystallinity. Proceed as directed in Using a 3-gram sample for each deter 141.201 e , f , and g and 141.5
mination, proceed as directed in c .
e Extinction coefficient. Dissolve 141.203 a if it is chlortetracycline approximately 40 milliliters of the powder, or as directed in 141.218 a if it is teracycline powder.

Continued on p. 7311

Page
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7329

Business and Defense Services Administration Notices:
Scarce and critical materials authorized for general distri bution in the civilian market__________________ ,________

7329

Civil Aeronautics Board Notices:
Hearings, etc.:
Accident occurring at Standiford Field, Louisville, K y
Central Airlines, Inc., et al.;
service to Fayetteville, Ark_
Northeast Airlines, Inc--------Proposed rule making :
Scheduled interstate air carrier certification and operation rules_______________________

7331
7330
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Commerce Department See Business and Defense Services Administration.

Defense Department See also Air Force Department;
Navy Department.
Rules and regulations:
Armed Services Procurement Regulation; contract clauses;
miscellaneous amendments-

7311

Defense Mobilization Office Notices:
Scarce and critical materials authorized for general distri bution in the civilian mar ket; revocation-----------------7309

7335