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TUAMINOHEPTANE

SULFATE NASAL PREPARATIONS. (See $310.201(a)(16) of this chapter.)

Caution-Do not exceed recommended dosage. Overdosage may cause nervousness, restlessness, or sleeplessness. Individuals with high blood pressure, heart disease, diabetes, or thyroid disease should use only as directed by physician. Do not use for more than 3 or 4 consecutive days unless directed by physician. VIBESATE PREPARATIONS. (See 8310.201(a)(18) of this chapter.)

Caution-Do not use but consult physician for deep or puncture wounds or serious burns. If redness, irritation, swelling, or pain persists or increases, discontinue use and consult physician.

Warning-Contents under pressure. Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 130° Fahrenheit may cause bursting. Never throw container into fire or incinerator.

physician, the Poison Control Center, or hospital emergency room immediately for advice.

The following warning: WarningKeep out of reach of children. Do not use in unconscious persons. Ordinarily, this drug should not be used if strychnine, corrosives such as alkalies (lye) and strong acids, or petroleum distillates such as kerosene, gasoline, coal oil, fuel oil, paint thinner, or cleaning fluid have been ingested. ISOAMYLHYRDOCUPREINE AND ZOLAMINE HYDROCHLORIDE RECTAL PREPARATIONS FOR EXTERNAL USE (See $310.201(a)(3) of this chapter.)

WarningDo not use this preparation in case of rectal bleeding, as this may indicate serious disease. NEOMYCIN SULFATE WITH A VASOCONSTRICTOR, IN NASAL PREPARATIONS (SPRAY OR DROPS).

Caution-Do not exceed recommended dosage. Do not administer to children under 3 years of age unless directed by physician. PRAMOXINE HYDROCHLORIDE FOR EXTERNAL USE. (See $310.201(a)(19) of this chapter.)

Caution-Do not use in the eyes or nose. Not for prolonged use. Do not apply to large areas of the body. If redness, irritation, swelling, or pain persists or increases, discontinue use unless directed by a physician. SODIUM GENTISATE. (See 88 201.314, 310.201(a)(2) of this chapter.)

Warning—Do not give to children under 6 years of age or use for prolonged period unless directed by physician.

Warning-Keep this and all medications out of the reach of children; or

Warning-Keep out of the reach of children.

If offered for use in arthritis or rheumatism, in juxtaposition therewith, the statement:

Caution-If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age, consult a physician immediately.

(39 FR 11745, Mar. 29, 1974, as amended at 40 FR 8917, Mar. 3, 1975; 40 FR 13496, Mar. 27, 1975; 41 FR 10885, Mar. 15, 1976; 42 FR 22033, Apr. 29, 1977; 42 FR 36994, July 19, 1977; 44 FR 22053, Apr. 13, 1979; 44 FR 55170, Sept. 25, 1979; 52 FR 15893, Apr. 30, 1987; 52 FR 30057, Aug. 12, 1987; 52 FR 47324, Dec. 11, 1987; 55 FR 11582, Mar. 29, 1990; 57 FR 58376, Dec. 9, 1992; 59 FR 4218, Jan. 28, 1994; 61 FR 20101, May 3, 1996)

§ 369.22 Drugs; warning and caution

statements specifically required by law.

PREPARATIONS

CONTAINING HABIT-FORMING DERIVATIVES OF SUBSTANCES NAMED IN SECTION 502(d) OF THE ACT. (See $$ 329.1, 329.10, and 329.20 of this chapter.)

The statement “WarningMay be habit forming" is required to appear on the labels of all drugs containing derivatives designated in $329.1 of this chapter as habit forming, including exempt narcotic preparations described in $329.20(a) of this chapter and preparations containing one or more derivatives of barbituric acid, unless such drug is not suitable for internal use and is distributed and sold exclusively for such external use as involves no possibility of habit formation.

PART 429-DRUGS COMPOSED WHOLLY OR PARTLY OF INSULIN

Subpart A-General Provisions

Sec. 429.3 Definitions and interpretations.

Subpart B-Packaging and Labeling

429.10 Packaging. 429.11 Labeling. 429.12 Distinguishing colors on packages.

Subpart C-Product Standards

429.25 Standards of quality and purity for

protamine. 429.26 Standards of quality and purity for

globin hydrochloride.

Subpart D-Tests and Methods

429.30 Tests and methods of assay.

Subpart E-Certification

429.40 Requests for certification; samples;

storage; approvals preliminary to certifi

cation. 429.41 Certifications. 429.45 Conditions on the effectiveness of cer

tificates. 429.47 Authority to refuse certification

service.

(d) The term U.S.P. means the official United States Pharmacopeia, including supplements thereto.

(e) The term N.F. means the official National Formulary, including supplements thereto.

(f) The definitions and interpretations of terms contained in section 201 of the act shall be applicable to such terms when used in the regulations in this part.

(g) The term insulin means the active principle of pancreas which affects the metabolism of carbohydrate in the animal body and which is of value in the treatment of diabetes mellitus.

(h) The term insulin injection means the insulin injection recognized in the U.S.P.

(i) The term protamine zinc insulin suspension means the protamine zinc insulin suspension recognized in the U.S.P.

(j) The term globin zinc insulin injection means the globin zinc insulin injection recognized in the U.S.P.

(k) The term isophane insulin suspension means the isophane insulin suspension recognized in the U.S.P.

(1) The term insulin zinc suspension means the insulin zinc suspension recognized in the U.S.P.

(m) The term prompt insulin zinc suspension means the prompt insulin zinc suspension recognized in the U.S.P.

(n) The term extended insulin zinc suspension means the extended insulin zinc suspension recognized in the U.S.P.

(0) The term master lot means a quantity (which is purified and which has been mixed in one container so as to be homogeneous) of:

(1) A concentrated solution of insulin; or

(2) The insulin-containing solids, in amorphous or crystalline form, derived from one or more such solutions.

(p) Except as provided in $429.41(c), the term batch means a quantity of a drug, in labeled packages, of uniform composition and intended for administration without further change, in which the sole insulin-containing ingredient is a single dilution (which has been mixed in one container so as to be homogeneous) of:

(1) A single master lot or part thereof; or

Subpart F-Administrative Procedures

429.50 Hearing procedure. 429.55 Fees.

Subpart G-Records

429.60 Records of distribution.

AUTHORITY: 21 U.S.C. 352, 356, 371.

CROSS REFERENCES: For other regulations in this chapter concerning insulin drugs, see also $ 200.15.

SOURCE: 39 FR 11750, Mar. 29, 1974, as amended at 40 FR 13497, Mar. 27, 1975, unless otherwise noted.

Subpart A-General Provisions

8 429.3 Definitions and interpretations.

For the purpose of the regulations in this part:

(a) The term act means the Federal Food, Drug, and Cosmetic Act, as amended.

(b) The term Secretary means the Secretary of Health and Human Services.

(c) The term Commissioner means the Commissioner of Food and Drugs.

(2) A mixture of two or more master (a) On the outside wrapper or conlots or parts thereof; except that such tainer and the immediate container of term means a portion of such quantity the retail package: when certification of such portion is (1) The batch mark of such batch; requested.

(2) The potency of the drug in terms (q) The term master lot mark means an

of the U.S.P. Units of insulin per milliidentifying mark or other identifying

liter; and device assigned to a master lot by the

(3) The statement "Expiration date manufacturer thereof.

" the blank being filled in with (r) The term batch mark means an

the date on which the certificate appli

cable to such batch expires with reidentifying mark or other identifying device assigned to a batch by the man

spect to such package, as provided in

$ 429.45(b)(1). ufacturer thereof.

(b) On the outside container or wrap[39 FR 11750, Mar. 29, 1974, as amended at 39 per of the retail package, the stateFR 40285, Nov. 15, 1974]

ment "Keep in a cold place, avoid

freezing." Subpart B-Packaging and

(c) If the batch contains 40 or 100 Labeling

U.S.P. Units of insulin per milliliter,

on the circular or other labeling of the 8 429.10 Packaging.

retail package:

(1) A statement that the treatment of Each batch shall be packaged in im

diabetes mellitus is an individual probmediate containers of colorless trans

lem and that the use of the drug, the parent glass. Such containers shall be

time of its administration, and the closed with a substance through which

number of daily doses and the quantity successive doses may be withdrawn by

of each, as well as diet and exercise, hypodermic needle without removing

are problems which require direct and the closure or destroying its effective

continuous medical supervision; ness. The containers and closures shall

(2) A statement explaining that the be sterile at the time the containers

volume of the dose depends on the are filled and closed. The composition

number of units of insulin per milliof the containers and closures shall be

liter stated on the label, and that the such as will not cause any change in patient should understand the meaning the strength, quality, or purity of the of the volume markings on the syringe; contents beyond any limit therefor pre- (3) A description of a practicable scribed in

in applicable standards of method for sterilizing the needle and strength, quality, and purity. The syringe before use; shape of the containers shall be cylin- (4) A description of the technique of drical, except that the cross-section of withdrawal from the vial and the use of the containers for isophane insulin sus- an antiseptic on the stopper, and a caupension containing less than 100 U.S.P. tion against the removal of the stopUnits of insulin per milliliter shall be a per; rounded square, and the shoulder of the (5) A description of the technique for containers for insulin zinc suspension, cleansing, and the use of an antiseptic prompt insulin zinc suspension, or ex- on the site of injection; tended insulin zinc suspension contain

(6) A statement that failure to coming less than 100 U.S.P. Units of insulin ply with the techniques described in per milliliter shall be hexagonal.

paragraphs (c) (3), (4), and (5) of this

section may lead to infection of the pa(39 FR 11750, Mar. 29, 1974, as amended at 39

tient; FR 40285, Nov. 15, 1974)

(7) A statement that injection should

be subcutaneous, at a different site 8429.11 Labeling.

from that of the preceding injection, Each package from a batch that has and a caution against intravenous or been certified in accordance with the intramuscular use; regulations in this part shall bear, on (8) An explanation of hypoglycemia its label or labeling as hereinafter indi- and its relation to overdosage, omiscated, the following:

sion of meals, illness, and infection;

or

(9) A statement of the significance of sugar in the urine and of the necessity of tests therefor; and

(10) A caution against use after the expiration date shown on the outside wrapper or container.

(d) On the circular or other labeling of the retail package, if the batch is insulin injection (in addition to the information required by paragraphs (a), (b), and (c) or (i) of this section), a caution against use if the drug has become viscous or if its color has become other than water clear.

(e) On the outside wrapper or container and immediate container of the retail package, if the batch is protamine zinc insulin suspension, isophane insulin suspension, insulin zinc suspension, prompt insulin zinc suspension, or extended insulin zinc suspension (in addition to the information required by paragraphs (a), (b), and (c) of this section), the statement "Shake carefully,” or “Shake well before using, or “Shake well,” “Shake carefully to suspend all particles."

(f) On the circular or other labeling of the retail package, if the batch is protamine zinc insulin suspension, isophane insulin suspension, insulin zinc suspension, prompt insulin zinc suspension, or extended insulin zinc suspension (in addition to the information required by paragraphs (a), (b), (c), and (e) of this section):

(1) An explanation of the difference, as compared with other insulin-containing drugs, in onset of action, duration, and the time and frequency of administration;

(2) A caution that it is not to be substituted for any other insulin-containing drug except on the advice and direction of a physician;

(3) A statement that a uniform suspension of the preparation is necessary and is brought about by careful shaking before use; and

(4) A caution against use when the precipitate has become lumped

or granular in appearance or has formed a deposit of solid particles on the wall of the container.

(g) On the circular or other labeling of the retail package, if the batch is globin zinc insulin injection (in addition to the information required by

paragraphs (a), (b), and (c) of this section):

(1) An explanation of the difference, as compared with other insulin-containing drugs, in onset of action, duration, and the time and frequency of administration;

(2) A caution that it is not to be substituted for any other insulin-containing drug, except on the advice and direction of a physician; and

(3) A caution against use if any turbidity or precipitate has developed in the solution.

(h) If the batch contains 500 U.S.P. Units of insulin per milliliter, on the outside container or wrapper and the immediate container of the retail package:

(1) The statement "Caution: Federal law prohibits dispensing without prescription";2 and

(2) The statement “Warning-High potency-Not for ordinary use".

(1) If the batch contains 500 U.S.P. Units of insulin per milliliter, on the circular or other labeling of the retail package:

(1) Information adequate for the safe and effective use of the drug, by practitioners licensed by law to administer it, in insulin shock therapy and for the treatment of diabetic patients with high insulin resistance (daily requirement more than 200 units);

(2) A prominently placed and conspicuous statement: “Warning-This insulin preparation contains 500 units of insulin in each milliliter. Extreme caution must be observed in measurement of dosage because inadvertent overdose may result in irreversible insulin shock. Serious consequences may result if it is used other than under constant medical supervision";

(3) A caution against intravenous use; and

(4) A caution against use after the expiration date shown on the outside wrapper or container.

(39 FR 11750, Mar. 29, 1974, as amended at 40 FR 13497, Mar. 27, 1975; 41 FR 6912, Feb. 13, 1976; 44 FR 55170, Sept. 25, 1979]

2 For the Spanish-language version of the required labeling statement, see $201.16(a), $ 801.16 and $290.6 of this chapter.

to distinguish each drug, and each potency of these drugs shall be distinguished by the following colors:

Red and lavender, if it contains 40 U.S.P. Units of insulin per milliliter.

Black and white, if it contains 100 U.S.P. Units of Insulin per milliliter.

8 429.12 Distinguishing colors on pack

ages. (a) The outside containers or wrappers of the packages, and the labels on the immediate containers of each potency of insulin injection shall be distinguished by the following colors:

Red, if it contains 40 U.S.P. Units of insulin per milliliter.

White, if it contains 100 U.S.P. Units of insulin per milliliter.

Narrow (at least 5 but not more than 20 to each inch) brown and white diagonal stripes, if it contains 500 U.S.P. Units of insulin per milliliter.

(39 FR 11750, Mar. 29, 1974, as amended at 39 FR 40286, Nov. 15, 1974; 44 FR 55170, Sept. 25, 1979)

Subpart C-Product Standards

But if the master lot used was in crystalline form, the distinguishing colors, instead of those prescribed above, may be the following:

8 429.25 Standards of quality and pu

rity for protamine. When protamine is dried to constant weight at 100° C., its total nitrogen content is not less than 22.5 percent and not more than 25.5 percent, and its sulfate content, calculated as SO4, is not less than 16 percent and not more than 19 percent.

Red and gray, if it contains 40 U.S.P. Units of insulin per milliliter.

(b) The outside containers or wrappers of the packages, and the labels on the immediate containers of each potency of protamine zinc insulin suspension shall be distinguished by the following colors:

8429.26 Standards of quality and pu

rity for globin hydrochloride. The ash content of globin hydrochloride is not more than 0.3 percent; its nitrogen content, calculated to moisture, ash, and hydrochloric acid free basis, is not less than 16.0 percent and not more than 17.5 percent.

Red and white, if it contains 40 U.S.P. Units of insulin per milliliter.

Black and white, if it contains 100 U.S.P. Units of insulin per milliliter.

(c) The outside containers or wrappers of the packages, and the labels of the immediate containers of each potency of globin zinc insulin injection shall be distinguished by the following colors:

Subpart D-Tests and Methods

Red and brown, if it contains 40 U.S.P. Units of insulin per milliliter.

Black and white, if it contains 100 U.S.P. Units of insulin per milliliter.

(d) The outside containers or wrappers of the packages, and the labels of the immediate containers of each potency of isophane insulin suspension shall be distinguished by the following colors:

$ 429.30 Tests and methods of assay.

The following tests and methods of assay are prescribed for the purposes of the regulations in this part 429. (All reagents specified in this section shall be of U.S.P. quality or better.)

(a) Tests and methods of assay for insulin injection, protamine zinc insulin suspension, globin zinc insulin injection, isophane insulin suspension, insulin zinc suspension, prompt insulin zinc suspension, and extended insulin zinc suspension. The tests and methods of assay for insulin injection, protamine zinc insulin suspension, globin zinc insulin injection, isophane insulin suspension, insulin zinc suspension, prompt insulin zinc suspension, and extended insulin zinc suspension shall be those set forth therefor in the U.S.P. or N.F., except that alternative test procedures may be employed when such have been authorized by the Commissioner.

(b) (Reserved)

Red and blue, if it contains 40 U.S.P. Units of insulin per milliliter.

Black and white, if it contains 100 U.S.P. Units of insulin per milliliter.

(e) The outside containers or wrappers of the packages, and the labels of the immediate containers, of insulin zinc suspension, prompt insulin zinc suspension, and extended insulin zinc suspension shall bear a mark or design

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