N.J. Admin. Code § 13:45H-8.15

Current through Register Vol. 56, No. 21, November 4, 2024

Section 13:45H-8.15 - Humane societies and animal care facilities

(a) Authorized agents of incorporated humane societies or licensed animal care facilities registered to purchase, possess, and to dispense sodium pentobarbital for animal euthanasia pursuant to 24:21-11.f shall be authorized to dispense:

1. Any commercially prepared sodium pentobarbital drug product for animal euthanasia approved for interstate sale by the United States Food and Drug Administration, provided the registrant complies with the approved recommended dosage regime in the labeling;

2. A standard compounded formula of sodium pentobarbital for animal euthanasia established by the Division as follows:

i. Sodium pentobarbital injection (for animal euthanasia), formula non-sterile solution:

U.S.P. Sodium Pentobarbital (Powder)	460 grams
Isopropyl Alcohol	250 mls.
Methyl Violet	1 drop
U.S.P. Water for injection quantity sufficient to make	1000 mls.

ii. Using the formula in (a)2i above, the strength of this mixture will provide 460 mgs of sodium pentobarbital per milliliter.

iii. Lethal dose: one milliliter per 10 pounds of body weight for small animals; horses and other large animals --one milliliter per 10 pounds of body weight subject to a maximum dose of 100 milliliters.

iv. Package and storage: Package in tight containers with rubber stoppers and store under refrigeration. Solutions decompose on standing. Heat accelerates the decomposition.

v. Expiration date: five days from date or manufacture.

(b) Labeling: sample labeling is as follows:

Data in image

1. Name and address, city and State of registrant;

2. Name of preparation: "Sodium Pentobarbital Injection";

3. Strength of the preparation: "460 milligrams per one milliliter";

4. "Lethal dose: one milliliter per 10 pounds of body weight for small animals; horses and large animals--one milliliter per 10 pounds of body weight subject to a maximum dose of 100 milliliters";

5. "Batch number . . . . . . . . . . . . . . . . . . . . . . . . . . . .";

6. "Net contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .";

7. "Expiration date . . . . . . . . . . . . . . . . . . . . . . . . . . .";

8. "Keep under refrigeration.";

9. "Warning: Do not use the injection if it contains a precipitate."

(c) A master formula and production record shall be made and retained on file at the formulating (compounding) site. This record shall contain:

1. Name, address, city and State of registrant;

2. Name and strength of the product and a description of the dosage form;

3. The name and weight or measure of each active ingredient including the control number of each such ingredient;

4. A statement of the theoretical yield of finished product;

5. A statement describing the equipment and utensils used in the formulating (compounding);

6. A description of the finished drug product containers and closures including a specimen or copy of each label and all other labeling signed and dated by the person or persons responsible for approval of such labeling; and

7. Complete manufacturing and control instructions, procedures, special notations and precautions to be followed.

(d) Batch production records shall be prepared for each batch of drug product produced and shall include complete information relating to the production of each batch. The records shall contain:

1. An accurate reproduction of the appropriate master formula production record, checked for accuracy, dated and signed;

2. Documentation that each significant step in the manufacture, processing, packaging or holding of the batch was accomplished, including:

i. Dates;

ii. Identity of the individual equipment used;

iii. Specific identification of each batch of component or materials used;

iv. Weights and/or measures of components used in processing;

v. Copy of all labeling used;

vi. Identification of the person performing each step in the process and identification of the person checking the weights, measures and operations;

vii. A statement of the theoretical yield; and

viii. A statement of the actual yield.

N.J. Admin. Code § 13:45H-8.15

Amended and Renumbered from 13:45H-8.13 by 47 N.J.R. 2300(a), effective 9/8/2015