Voglio sapere a riguardo di…

RULES AND REGULATIONS

5006
filed March 2, 1948; exceptions to said recommended decision filed by the re spondent, and brief of counsel in support of motion to amend order to cease and desist; and It appearing to the Commission that it is the public understanding that an effective antifreeze is a preparation which prevents freezing in the radiators and motors of automobiles and is such a substance which will not cause damage to radiators, engines, motors, or other parts of automobiles when used; and It further appearing that the repre sentation that respondents products, when used under the suggested directions of the respondent as to proper quantities thfereof for designated temperatures, are effective as antifreeze solutions con veys the meaning to the public that said products are safe and harmless solutions for general use in automobile radiators;
and It further appearing that the respond ent, by its answer in this proceeding, admitted that its preparations are not safe antifreeze preparations for gen eral use from the standpoint of cor rosion, as they will cause corrosion in the cooling system in which they are con tinually used which will in many in stances lessen the effectiveness of the cooling system and cause the engine to overheat and cause corrosion on spark plugs, ignition wires and other metal parts of the automobile with which such products come in contact, in many in stances causing shorts in the ignition system; and The Commission being of the opinion that the proviso contained in paragraph 1 of the order is contrary to fact and contrary to the admissions in the plead ings, and the Commission being fur ther of the opinion that the public inter est requires that the order to cease and desist be modified to conform with the facts and the record herein:
I t is ordered, That the order to cease and desist heretofore issued on January 31, 1938, be, and the same hereby is, modified by striking from paragraph 1
thereof the following proviso: Provided, however, Respondent is not prohibited from representing that said products, as now composed, when used under the suggested directions of respondent as to proper quantities thereof for designated temperatures, are effective as anti freeze solutions.
By the Commission.
seal
D . C. D a n i e l ,
Secretary.
F . R: D oc . 49-6612; Filed, Aug.
8:47 a. m .

12, 1949; .

TITLE 21 FOOD

DRUGS

AND

Chapter I Food and Drug Adminis tration, Federal Security Agency P art
141 T e sts for
and M ethods o f A ssay A n t ib io t ic D rugs
P art 146 C e r t if ic a t io n o f B a tch es of P e n i c i l l i n - or S t r e p t o m y c in - C o n
t a in in g D rugs MISCELLANEOUS AMENDMENTS

By virtue of the authority vested in the Federal Security Administrator by
ml. of agar which has been melted and cooled to 48 C.
6 Preparation of plates. Add 21 ml.
of the agar prepared as in subparagraph 2 of this paragraph to each Petri dish 20 x 100 mm.. Distribute the agar evenly in the plates and allow it to harden. Use the plates the same day they are prepared. Add 4 ml. of the in oculum prepared as in subparagraph 5
of this paragraph for each plate, tilting the plates back and forth to spread the inoculated agar evenly over the surface.
7 Assay. Place six cylinders on the inoculated agar surface so that they are at approximately 60 intervals on a 2.8cm. radius. Use three plates for each sample. Fill three cylinders on each plate with the 10 micrograms per milli 141.201 Aureomycin hydrochloride a Potency 1 Cylinders cups. Use liter standard and three cylinders with the 10 micrograms per milliliter esti cylinders described under 141.1 a .
mated sample, alternating standard 2 Culture media. Use the medium and sample. At the same time, prepare described under 141.1 b 1 for both a standard curve, using concentrations the seed layer and the base layer. Use of the standard of 4.0, 6.0, 8.0, 10.0, 13.0, the nutrient broth , described under 17.0, 22.0, and 29.0 micrograms per milli 141.1 b 3 for preparing a suspen liter in 1% potassium acid phthalatesion of the test organism.
tartaric acid buffer pH 3.0. A total of 3 Working standard. Weigh out 21 plates is used in the preparation of the carefully an appropriate amount of the standard curve, three plates for each aureomycin working standard and dilute solution except the 10 micrograms per to 1000 micrograms per milliliter in 1%
milliliter solution. The latter concen potassium acid phthalate-tartaric acid tration is used as the reference point and buffer pH 3.0. The standard solution is included on each plate. On each of when refrigerated may be used for 3 days.
three plates fill 3 cylinders with the 10
The standard solution may be preserved micrograms per milliliter standard and for at least 2 months by freezing in small the other 3 cylinders with the concentra aliquots. Each aliquot should be suffi tion of the standard under test. Thus, cient for one days use only.
there will be 63 ten-microgram determi 4 Preparation of sample. Dissolve nations and nine determinations for each the sample to be tested in sterile distilled of the other points on the curve. Incu water to make an appropriate stock solu bate the plates for 16 to 18 hours at 37
tion. Further dilute this solution volC. and measure ih e diameter of each umetrically with 1% .potassium acid circle of inhibition. Average the read phthalate-tartaric acid buffer pH 3.0 to ings of the 10 micrograms per milliliter contain 10.0 micrograms per milliliter concentration and the readings of the estimated.
point tested for each set of three plates, 5 Preparation of suspension. The and average also all 63 readings of the test organism is Sarcina lutea P. C. I.
10 micrograms per milliliter concentra 1001. Maintain the test organism on tion. The average of the 63 readings of slants of nutrient agar prepared as in the 10 micrograms per milliliter concen subparagraph 2 of this paragraph and tration is the correction point for the transfer to a fresh agar slant once a curve. Correct the average value ob week. Prepare a suspension of the test tained for each point to the figure it organisms as follows: Streak an agar would be if the 10 micrograms per milli slant heavily with, the test organism.
liter reading for that set of three plates Wash the growth off in about 3 ml. of nu were the same as the correction point.
trient broth. Use the suspension so ob Thus, if in correcting the 8.0 micrograms tained to inoculate the surface of a Roux per milliliter concentration the average bottle containing 300 ml. of the nutrient of the 63 readings of the 10 micrograms agar. Spread the suspension over the per milliliter is 18.0 miff., and the average entire surface with the aid of sterile glass of the 10 micrograms per milliliter con beads. Incubate for 24 hours at 26 C.
centration of this set of three plates is Wash the growth from the agar surface 17.8 mm., the correction is 0.2 mm. If with 50 ml. of nqtrient broth prepared as the average reading of the 8.0 micro in subparagraph 2 of this paragraph.
grams per milliliter concentration of I f an aliquot of this bulk suspension, those same three plates is 17.0 mm., the when diluted 1:50 in physiological saline corrected value is then 17.2 mm.
solution, gives 75% light transmission in Plot these corrected values, including a suitable photoelectric colorimeter the average of the 10 micrograms per equipped with a filter having a wave milliliter concentrations on two-cycle length of 6500 Angstrom units, the bulk semilog paper, using the concentration in suspension is satisfactory for use. It may micrograms per milliliter as the ordinate be necessary to adjust the bulk suspen the logarithmic scale and the diameter sion by dilution so that an aliquot of the of the zone of inhibition as the abscissa.
adjusted suspension diluted 1:50 gives Draw the standard curve through these 75% light transmission. The adjusted points.
bulk suspension only, and not the 1:50
To estimate the potency of the sample, dilution of it, is used in preparing the average the zone readings of the stand seed layer. The bulk suspension may ard and the zone readings of the sam be used for at least 1 week. Add 0.4 ml.
of the adjusted bulk suspension to 100
ple on the three plates used. I f the samthe provisions of section 507 of the Fed eral Food, Drug, and Cosmetic Act 52
Stat. 1040, 1055, as amended by 59 Stat.
463, 61 Stat. 11, and Public Law 164, 81st Cong.; 21 U. S. C. 357 the regulations for tests and methods of assay for anti biotic and antibiotic-containing drugs 12 F. R. 2215 and certification of batches of antibiotic and antibioticcontaining drugs 12 F. R. 2231; 13 F. R.
1087 are amended as indicated below.
1. The heading of Part 141, Tests and Methods of Assay for Antibiotic Drugs, is changed to read Tests and Methods of Assay for Antibiotic and AntibioticContaining Drugs.
2. The following new sections are added: