Sale of New Drug for Emergency Treatment
C.08.010. (1) The Director may issue a letter of authorization authorizing the sale of a quantity of a new drug for human or veterinary use to a practitioner named in the letter of authorization for use in the emergency treatment of a patient under the care of that practitioner, if
(a) the practitioner has supplied to the Director information concerning
(i) the medical emergency for which the drug is required,
(ii) the data in the possession of the practitioner with respect to the use, safety and efficacy of that drug,
(iii) the names of all institutions in which the drug is to be used, and
(iv) such other data as the Director may require; and
(b) the practitioner has agreed to
(i) report to the manufacturer of the new drug and to the Director on the results of the use of the drug in the medical emergency, including information respecting any adverse reactions encountered, and
(ii) account to the Director on request for all quantities of the drug received by him.
(1.1) The Director shall not issue a letter of authorization under subsection (1) for a new drug that is or that contains a restricted drug as defined in section J.01.001.
(2) The Director shall, in any letter of authorization issued pursuant to subsection (1), state
(a) the name of the practitioner to whom the new drug may be sold;
(b) the medical emergency in respect of which the new drug may be sold; and
(c) the quantity of the new drug that may be sold to that practitioner for that emergency.
- SOR/2013-172, s. 11.
C.08.011. (1) Notwithstanding section C.08.002, a manufacturer may sell to a practitioner named in a letter of authorization issued pursuant to section C.08.010, a quantity of the new drug named in that letter that does not exceed the quantity specified in the letter.
(2) A sale of a new drug made in accordance with subsection (1) is exempt from the provisions of the Act and these Regulations.
Sale of Medicated Feeds
C.08.012. (1) Notwithstanding anything in this Division, a person may sell, pursuant to a written prescription of a veterinary practitioner, a medicated feed if
(a) as regards the drug or drugs used as the medicating ingredient of the medicated feed,
(i) the Director has assigned a drug identification number pursuant to section C.01.014.2, or
(ii) the sale is permitted by section C.08.005, C.08.011 or C.08.013;
(b) the medicated feed is for the treatment of animals under the direct care of the veterinary practitioner who signed the prescription;
(c) the medicated feed is for therapeutic purposes only; and
(d) the written prescription contains the following information:
(i) the name and address of the person named on the prescription as the person for whom the medicated feed is to be mixed,
(ii) the species, production type and age or weight of the animals to be treated with the medicated feed,
(iii) the type and amount of medicated feed to be mixed,
(iv) the proper name, or the common name if there is no proper name, of the drug or each of the drugs, as the case may be, to be used as medicating ingredients in the preparation of the medicated feed, and the dosage levels of those medicating ingredients,
(v) any special mixing instructions, and
(vi) labelling instructions including
(A) feeding instructions,
(B) a warning statement respecting the withdrawal period to be observed following the use of the medicated feed, and
(C) where applicable, cautions with respect to animal health or to the handling or storage of the medicated feed.
(2) For the purpose of this section, “medicated feed” has the same meaning as in the Feeds Regulations.
- SOR/80-741, s. 1;
- SOR/92-130, s. 1;
- SOR/93-202, s. 27.
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