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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.

PREPARATIONS

ISOAMYLHYRDOCUPREINE AND ZOLAMINE HYDROCHLORIDE RECTAL FOR EXTERNAL USE (See §310.201(a)(3) of this chapter.) Warning-Do 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 §§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.

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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.

[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]

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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 "Warning-May 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.

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(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

(2) A mixture of two or more master lots or parts thereof; except that such term means a portion of such quantity when certification of such portion is requested.

(q) The term master lot mark means an identifying mark or other identifying device assigned to a master lot by the manufacturer thereof.

(r) The term batch mark means an identifying mark or other identifying device assigned to a batch by the manufacturer thereof.

[39 FR 11750, Mar. 29, 1974, as amended at 39 FR 40285, Nov. 15, 1974]

Subpart B-Packaging and
Labeling

§ 429.10 Packaging.

Each batch shall be packaged in immediate containers of colorless transparent glass. Such containers shall be closed with a substance through which successive doses may be withdrawn by hypodermic needle without removing the closure or destroying its effectiveness. The containers and closures shall be sterile at the time the containers are filled and closed. The composition of the containers and closures shall be such as will not cause any change in the strength, quality, or purity of the contents beyond any limit therefor prescribed in applicable standards of strength, quality, and purity. The shape of the containers shall be cylindrical, except that the cross-section of the containers for isophane insulin suspension containing less than 100 U.S.P. Units of insulin per milliliter shall be a rounded square, and the shoulder of the containers for insulin zinc suspension, prompt insulin zinc suspension, or extended insulin zinc suspension containing less than 100 U.S.P. Units of insulin per milliliter shall be hexagonal.

[39 FR 11750, Mar. 29, 1974, as amended at 39 FR 40285, Nov. 15, 1974]

§ 429.11 Labeling.

Each package from a batch that has been certified in accordance with the regulations in this part shall bear, on its label or labeling as hereinafter indicated, the following:

(a) On the outside wrapper or container and the immediate container of the retail package:

(1) The batch mark of such batch;

(2) The potency of the drug in terms of the U.S.P. Units of insulin per milliliter; and

(3) The statement "Expiration date ," the blank being filled in with the date on which the certificate applicable to such batch expires with respect to such package, as provided in § 429.45(b)(1).

(b) On the outside container or wrapper of the retail package, the statement "Keep in a cold place, avoid freezing."

(c) If the batch contains 40 or 100 U.S.P. Units of insulin per milliliter, on the circular or other labeling of the retail package:

(1) A statement that the treatment of diabetes mellitus is an individual problem and that the use of the drug, the time of its administration, and the number of daily doses and the quantity of each, as well as diet and exercise, are problems which require direct and continuous medical supervision;

(2) A statement explaining that the volume of the dose depends on the number of units of insulin per milliliter stated on the label, and that the patient should understand the meaning of the volume markings on the syringe; (3) A description of a practicable method for sterilizing the needle and syringe before use;

(4) A description of the technique of withdrawal from the vial and the use of an antiseptic on the stopper, and a caution against the removal of the stopper;

(5) A description of the technique for cleansing, and the use of an antiseptic on the site of injection;

(6) A statement that failure to comply with the techniques described in paragraphs (c) (3), (4), and (5) of this section may lead to infection of the patient;

(7) A statement that injection should be subcutaneous, at a different site from that of the preceding injection, and a caution against intravenous or intramuscular use;

(8) An explanation of hypoglycemia and its relation to overdosage, omission of meals, illness, and infection;

(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," or "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

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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.

§ 429.12 Distinguishing colors on packages.

(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.

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

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:

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:

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:

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

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.

[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

§ 429.25 Standards of quality and purity 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.

§ 429.26 Standards of quality and purity 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.

Subpart D-Tests and Methods

§ 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]

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