Food and Drug Regulations (C.R.C., c. 870)

C.04.676. Reference standards for anterior pituitary extract shall be

• (a) the International Standard,

• (b) where no International Standard exists, the Canadian Reference Standard shall be that established and kept by the Director from whom portions for comparative testing may be had upon application, and

• (c) where neither an International Standard nor a Canadian Reference Standard exists, a provisional reference standard that shall be a suitable quantity of the product submitted by the distributor referred to in paragraph C.01A.003(b) to the Director for checking the uniformity of the product.

C.04.677. Both the inner and outer labels of an anterior pituitary extract shall carry a statement of the potency in terms of the reference standard for anterior pituitary extract provided in section C.04.676 as determined by an acceptable method, except that where no reference standard for an anterior pituitary extract exists, the distributor referred to in paragraph C.01A.003(b) shall include, with every package of the anterior pituitary extract, an acceptable statement of the unit of potency and the method of assay used.

C.04.678. No person who holds an establishment licence shall sell corticotrophic hormones for subcutaneous or intramuscular use unless the preparation has been assayed by an acceptable method involving subcutaneous injection and, where the preparation is recommended for intravenous use, the label carries specific dosage instructions for that use.

C.04.679. No person shall sell as such adrenocorticotrophic hormone, thyrotrophic hormone, growth hormone pituitary, lactogenic hormone, or gonadotrophic hormone that is not acceptable free from any anterior pituitary extract other than the one for which it is named.

C.04.680. The outer label of a mixture of two or more of adrenocorticotrophic hormone, thyrotrophic hormone, growth hormone pituitary, lactogenic hormone and gonadotrophic hormone, or a mixture of any of those with pituitary extract anterior lobe, shall carry a declaration of the proper name and the amount of each component of the mixture.

C.04.681. The outer label of an anterior pituitary extract or mixture of anterior pituitary extracts shall carry a statement

• (a) showing the species of animal from which the glands used in the preparation of the anterior pituitary extract were obtained,

• (b) that it shall be stored at refrigerator temperature, and

• (c) that, except in the case of gonadotrophic hormones, it is to be used only on the advice or on the prescription of a physician.