§ 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.

(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.

(l) 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.

(o) 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.