Food and Drug Regulations

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.