Laws and Regulations Promulgated to Give Effect to the Provisions of the International Treaties on Narcotic Drugs and Psychotropic Substances

Home , Food and Drugs Act, Metethoheptazine, Metheptazine, Oxpheneridine, Thiambutenes

UNITED NATIONS E/NL.1980/45-48* 12 November I984 ENGLISH ONLY Original: ENGLISH AND LAWS AND REGULATIONS PROMULGATED TO GIVE EFFECT TO THE PROVISIONS OF THE INTERNATIONAL TREATIES ON NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES

In accordance with the relevant articles of the international treaties on narcotic drugs and psychotropic substances, the Secretary-General has the honour to communicate the following legislative texts.

CANADA Communicated "by the Government of Canada

NOTE BY THE SECRETARIAT

a) Internationa! non-proprietary names in the text have been underlined by the Secretariat. b) Some editing of texts may be done by the Secretariat in the interest of clarity. In this connection, words in square brackets [ ] have been added or changed by the Secretariat. c) Only passages directly relevant to the control of narcotic drugs or psycho• tropic substances have been reproduced in thjs document. Non-relevant parts of laws and regulations have been deleted by the Secretariat; such deletions are indicated by [...].

INDEX Page E/NL.1980/45 Narcotic Control Act, amended by 1978-79 1 E/NL.1980/46 Narcotic Control Regulations, amended by P.C. 1978-444 16 E/NL.1980/47 Food and Drugs Act, amended by 1976-77 37 E/NL.1980/48 Food and Drugs Regulations, amended by C.R.C. 870, Part G 54 and P.C. 1979-2831, Part J

Office Consolidation E/NL.1980/45 February 1980

NARCOTIC CONTROL ACT 1/ Amended 1978-79

CHAPTER N-l AN ACT TO PROVIDE FOR THE CONTROL OF NARCOTIC DRUGS

Short Title

1. This Act may be cited as the Narcotic Control Act. Short title 1960-61, c. 35, s. 1.

Interpretation

2. In this Act Definitions

"analyst" means a person designated as an analyst under "analyst" the Food and Drugs Act or under this Act; "analyste"

* Authentic texts in French were also transmitted by the Government of Canada and are available from the Secretariat on request.

V.8H 8060U E/NL.1980/45-48 Page 2 E/NL.1980/45-48 Page 3

(b) upon conviction on indictment, to imprisonment for seven years. 1960-61, c. 35, s. 3; 1968-69, c. 41, s. 12.

4. (1) No person shall traffic in a narcotic or any Trafficking substance represented or held out by him to be a narcotic,

(2) No person shall have in his possession any Possession for purpose narcotic for the purpose of trafficking. of trafficking

(3) Every person who violates subsection (1) or (2) Offence is guilty of an indictable offence and is liable to imprisonment for life. 1960-61, c. 35, s. 4.

5. (1) Except as authorized by this Act or the Importing and exporting regulations, no person shall import into Canada or export from Canada any narcotic.

(2) Every person who violates subsection (1) Offence is guilty of an indictable offence and is liable to imprisonment for life but not less than seven years. 1960-61, c. 35, s. 5.

6. (1) No person shall cultivate opium poppy or Cultivation of opium marihuana except under authority of and in accordance poppy or marihuana with a licence issued to him under the regulations.

(2) Every person who violates subsection (1) is Offence guilty of an indictable offence and is liable to imprisonment for seven years.

(3) The Minister may cause to be destroyed any Destruction of plant growing plant of opium poppy or marihuana cultivated otherwise than under authority of and in accordance with a licence issued under the regulations. 1960-61, c.35,s.6.

Prosecutions

7. (1) No exception, exemption, excuse or Burden of proving qualification prescribed by law is required exception, etc. to be set out or negatived, as the case may be, in an information or indictment for an offence under this Act or under section 421, 422 or 423 of the Criminal Code in respect of an offence under this Act.

(2) In any prosecution under this Act the burden of Idem proving that an exception, exemption, excuse or qualification prescribed by law operates in favour of the accused is on the accused, and the prosecutor is not required, except by way of rebuttal, to prove that the exception, exemption, excuse or qualification does hot operate in favour of the accused, whether or not it is set out in the information or indictment. 1960-61, c. 35, s. 7.

8. In any prosecution for a violation of subsection 4 (2), Procedure in prosecution if the accused does not plead guilty, the trial shall for trafficking proceed as if it were a prosecution for an offence under section 3, and after the close of the case for the prosecution and after the accused has had an opportunity E/NL.1980/45-48 Page 4

to make full answer and defence, the court shall make a finding as to whether or not the accused was in possession of the narcotic contrary to section 3; if the court finds that the accused was not in possession of the narcotic contrary to section 3, he shall be acquitted but if the court finds that the accused was in possession of the narcotic contrary to section 3, he shall be given an opportunity of establishing that he was not in possession of the narcotic for the purpose of trafficking, and thereafter the prosecutor shall be given an opportunity of adducing evidence to establish that the accused was in possession of the narcotic for the purpose of trafficking; if the accused establishes that he was not in possession of the narcotic for the purpose of trafficking, he shall be acquitted of the offence as charged but he shall be convicted of an offence under section 3 and sentenced accordingly; and if the accused fails to establish that he was not in possession of the narcotic for the purpose of trafficking, he shall be convicted of the offence as charged and sentenced accordingly. 1960-61, c. 35, s. 8.

Certificate of analyst 9. (1) Subject to this section, a certificate of an analyst stating that he has analyzed or examined a substance and stating the result of his analysis or examination is admissible in evidence in any prosecution for an offence mentioned in subsection 7 (1), and in the absence of evidence to the contrary is proof of the statements contained in the certificate without proof of the signature or the official character of the person appearing to have signed the certificate.

Attendance of analyst (2) The party against whom a certificate of an analyst is produced pursuant to subsection (1) may, with leave of the court, require the attendance of the analyst for the purposes of cross-examination.

Notice (3) No certificate shall be received in evidence pursuant to subsection (1) unless the party intending to produce it has, before the trial, given to the party against whom it is intended to be produced reasonable notice of such intention together with a copy of the certificate. 1968-69, c. 41, s. 12.

Search, Seizure and Forfeiture

Search and seizure 10. (1) A peace officer may, at any time,

(a) without a warrant enter and search any place other than a dwelling-house, and under the authority of a writ of assistance or a warrant issued under this section, enter and search any dwelling-house in which he reasonably believes there is a narcotic by means of or in respect of which an offence under this Act has been committed;

(b) search any person found in such place; and

(c) seize and take away any narcotic found in such place, any thing in such place in which he reasonably suspects a narcotic is contained or concealed, or any E/NL.1980/45-48 Page 5

other thing by means of or in respect of which he reasonably believes an offence under this Act has been committed or that may be evidence of the commission of such an offence.

(2) A justice who is satisfied by information Warrant to search upon oath that there are reasonable grounds for dwelling-house believing that there is a narcotic, by means of or in respect of which an offence under this Act has been committed, in any dwelling-house may issue a warrant under his hand authorizing a peace officer named therein at any time to enter the dwelling-house and search for narcotics.

(3) A judge of the Federal Court of Canada shall, Writ of assistance upon application by the Minister, issue a writ of assistance authorizing and empowering the person named therein, aided and assisted by such person as the person named therein may require, at any time, to enter any dwelling-house and search for narcotics.

(4) For the purpose of exercising his authority Powers of peace officer under this section, a peace officer may, with such assis• tance as he deems necessary, break open any door, window, lock, fastener, floor, wall, ceiling, compartment, plumbing fixture, box, container or any other thing.

(5) Where a narcotic or other thing has been seized Application for under subsection (1), any person may, within two months restoration from the date of such seizure, upon prior notification having been given to the Crown in the manner prescribed by the regulations, apply to a magistrate within whose terri• torial jurisdiction the seizure was made for an order of restoration under subsection (6).

(6) Subject to subsections (8) and (9), where Order of restoration upon the hearing of an application made under sub• section (5) the magistrate is satisfied

(a) that the applicant is entitled to possession of the narcotic or other thing seized, and

(b) that the thing so seized is not or will not be required as evidence in any proceedings in respect of an offence under this Act, he shall order that the thing so seized be restored forth• with to the applicant, and where the magistrate is satis• fied that the applicant is entitled to possession of the thing so seized but is not satisfied as to the matters mentioned in paragraph (b), he shall order that the thing so seized be restored to the applicant

(c) upon the expiration of four months from the date of the seizure, if no proceedings in respect of an offence under this Act have been commenced before that time, or

(d) upon the final conclusion of any such proceedings, in any other case. E/NL.1980/45-48 Page 6

Where no application (7) Where no application has been made for the return made of any narcotic or other thing seized under subsection (1) within two months from the date of such seizure, or an application therefor has been made but upon the hearing thereof no order of restoration is made, the thing so seized shall be delivered to the Minister who may make such disposition thereof as he thinks fit.

Forfeiture of narcotic (8) Where a person has been convicted of an offence upon conviction under section 3, 4 or 5, any narcotic seized under sub• section (1), by means of or in respect of which the offence was committed, any money so seized that was used for the purchase of that narcotic and any hypodermic needle, syringe, capping machine or other apparatus so seized that was used in any manner in connection with the offence is forfeited to Her Majesty and shall be disposed of as the Minister directs.

Forfeiture of conveyance (9) Where a person has been convicted of an offence upon application under section 4 or 5, the court may, upon application by counsel for the Crown, order that any conveyance seized under subsection (1) that has been proved to have been used in any manner in connection with the offence be forfeited, and upon such order being made the conveyance is forfeited to Her Majesty and, except as provided in section 11, shall upon the expiration of thirty days from the date of such forfeiture be disposed of as the Minister directs. 1960-61, c. 35, s. 10; 1968-69, c. 41, s. 14.

Application by person 11. (1) Where any conveyance is forfeited to Her Majesty claiming interest under subsection 10 (9), any person (other than a person convicted of the offence that resulted in the forfeiture or a person in whose possession the conveyance was when seized) who claims an interest therein as owner, mortgagee, lienholder or holder of any like interest may, within thirty days after such forfeiture, apply by notice in writing to a judge for an order under subsection (4).

Date of hearing (2) The judge to whom an application is made under subsection (1) shall fix a day not less than thirty days after the date of filing of the application for the hearing thereof.

Notice (3) The applicant shall serve a notice of the application and of the hearing upon the Minister at least fifteen days before the day fixed for the hearing.

Order by judge (4) Where, upon the hearing of an application, it is made to appear to the satisfaction of the judge,

(a) that the applicant is innocent of any complicity in the offence that resulted in the forfeiture and of any collusion in relation to that offence with the person who was convicted thereof, and

(b) that the applicant exercised all reasonable care in respect of the person permitted to obtain possession of the conveyance to satisfy himself that it was not likely to be used in connection with the commission of an unlawful act or, in the case of a E/NL.1980/45-48 Page 7

mortgagee or lienholder, that he exercised such care with respect to the mortgagor or lien-giver, the applicant is entitled to an order declaring that his interest is not affected by such forfeiture and declaring the nature and extent of his interest.

(5) The applicant or the Minister may appeal to Appeal the court of appeal from an order made under subsection (4) and the appeal shall be asserted, heard and decided according to the ordinary procedure governing appeals to the court of appeal from orders or judgments of a judge.

(6) The Minister shall, upon application made Application to Minister to him by any person who has obtained a final order under this section,c (a) direct that the conveyance to which the interest of the applicant relates be returned to the applicant; or

(b) direct that an amount equal to the value of the interest of the applicant, as declared in the order, be paid to him.

(7) In this section Definitions

"court of appeal" means, in the province in which an "court of appeal" order under this section is made, the court of appeal for that province as defined in the definition "court of appeal" in section 2 of the Criminal Code;

"judge" means "judge"

(a) in the Province of Quebec, judge of the Superior Court for the district in which the con• veyance in respect of which an application for an order under this section is made, was seized,

Cb) in the Provinces of Newfoundland and Prince Edward Island, a judge of the Supreme Court thereof,

(b.l) in the Provinces of New Brunswick, Alberta and Saskatchewan, a judge of the Court of Queen's Bench thereof,

(d) in any province not referred to in para- - graphs (a) to (c), a judge of the county or district court for the county or district in which any such conveyance was seized. R.S., c. N-l, s. 11; 1972, c. 17, s. 2; 1974-75-76, c. 48, s. 25; 1978-79, c. 11, s. 10.

General

12. The Governor in Council may make regulations Regulat ions E/NL. 1980/45-48 Page 8

(a) providing for the issue of licences

(i) for the importation, export, sale, manufacture, production or distribution of narcotics, and

(ii) for the cultivation of opium poppy or marihuana;

(b) prescribing the form, duration and terms and con• ditions of any licence described in paragraph (a) and the fees payable therefor, and providing for the can• cellation and suspension of such licences;

(c) authorizing the sale or possession of or other dealing in narcotics and prescribing the circumstances and conditions under which and the persons by whom narcotics may be sold, had in possession or otherwise dealt in;

(d) requiring physicians, dentists, veterinarians, pharmacists and other persons who deal in narcotics as authorized by this Act or the regulations to keep records and make returns;

(e) authorizing the communication of any information obtained under this Act or the regulations to provin• cial professional licensing authorities;

(f) prescribing the punishment by a fine not ex• ceeding five hundred dollars or imprisonment for a term not exceeding six months, or both, to be imposed upon summary conviction for breach of any regulation; and

(g) generally, for carrying out the purposes and pro• visions of this Act. 1960-61, c. 35, s. 12.

Designation of analyst 13. The Governor in Council may designate any person as an analyst for the purpose of this Act. 1960-61, c. 35, s. 13.

Amendment of schedule 14. The Governor in Council may, from time to time, amend the schedule by adding thereto or deleting therefrom any substance, the inclusion or exclusion of which, as the case may be, is deemed necessary by him in the public interest. 1960-61, c. 35, s. 14.

PART II a/

PREVENTIVE DETENTION AND CUSTODY FOR TREATMENT

Sentence of preventive 15. Where a person is convicted of an offence under detention section 4 or 5, the court shall, if that person

(a) has been previously convicted on at least one separate and independent occasion of an offence under section 4 or 5 of this Act or an offence under

a/ Note: Part II (sections 15 to 19) comes into force on proclamation. (SOR/61-359) E/NL.1980/45-48 Page 9

subsection 4 (3) of chapter 201 of the Revised Statutes of Canada, 1952, or

(b) has been previously sentenced to preventive detention under this section, impose a sentence of preventive detention in a penitentiary for an indeterminate period, in lieu of any other sentence that might be imposed for the offence of which he was convicted. 1960-61, c. 35, s. 15.

16. Where any person is charged with an offence under Remand for observation section 3, 4 or 5, the court or any judge having and examination jurisdiction to try the offence may, upon application by counsel for the Crown, or upon application by the person charged with the offence or by counsel for such person, either before or after such person is committed for trial and before any sentence that might be imposed for the offence is passed, remand such person, by order in writing, to such custody as the court directs for observation and examination for a period not exceeding seven days. 1960-61, c. 35, s. 16.

17. (1) Where a person who has been remanded to custody Sentence to custody for for observation and examination pursuant to section 16 is treatment convicted of the offence in respect of which he was remanded to such custody, the court shall, before passing sentence, consider the evidence arising out of the observation and examination, including the evidence of at least one duly qualified medical practitioner and such other evidence as may be adduced, and where the court is satisfied, upon consideration of such evidence, that the convicted person is a narcotic addict, the court shall, notwithstanding anything in section 15, sentence him to custody for treatment for an indeterminate period, in lieu of any other sentence that might be imposed for the offence of which he was convicted.

(2) A person who is sentenced to custody for Appeal treatment for an indeterminate period under this section may appeal to the court of appeal against the sentence on any ground of law or fact or mixed law and fact.

(3) The provisions of section 695 of the Criminal Application of Code with respect to appeals against a sentence of Criminal Code preventive detention apply mutatis mutandis to an appeal under this section. 1960-61, c. 35, s. 17.

18. (1) Where a person is sentenced to custody for Confinement for treatment treatment for an indeterminate period he shall be confined for treatment in an institution maintained and operated pursuant to the Penitentiary Act.

(2) A person who is sentenced to custody for Application of Parole Act treatment for an indeterminate period is subject to the Parole Act and, for all purposes of that Act, shall be deemed

(a) during his period of confinement to be an inmate within the meaning of that Act, and

(b) upon release under certificate of the Parole Board, to be a paroled inmate within the meaning of that Act. E/NL.1980/45-48 Page 10

Limitation (3) A sentence of custody for treatment for an indeterminate period, where the person so sentenced has not, at any time before the conviction resulting in the sentence, been convicted of an offence under this Act or an offence under chapter 201 of the Revised Statutes of Canada, 1952, expires at the end of such period, not exceeding ten years from the date of his release under certificate of the Parole Board, as may be fixed by the Parole Board, unless before that time his parole is forfeited or revoked. 1960-61, c. 35, s. 18.

Agreement 19. (1) Where the legislature of a province enacts with province legislation that is designed' to provide custody for treatment for persons who, although not charged with the offence of possession of a narcotic, are narcotic addicts, the Minister may enter into an agreement with the province, subject to the approval of the Governor in Council, for the confinement and treatment of such persons in institutions maintained and operated pursuant to the Penitentiary Act and for the release and supervision of such persons pursuant to the Parole Act.

Idem (2) A narcotic addict who is committed to custody for treatment pursuant to an Act of the legislature of a province shall be deemed, for the purposes of the Penitentiary Act and the Parole Act, to have been sentenced to custody for treatment under this Act. 1960-61, c. 35, s. 19.

SCHEDULE

1. Opium poppy (Papaver somriiferum), its preparations, derivatives, alkaloids and salts, including:

(1) Opium

(2) Codeine (Methylmorphine)

(3) Morphine

(4) Thebaine,

and their preparations, derivatives and salts, including:

(5) Acetorphihe

(6) Acetyldihydrocodeine

(7) Benzylmorphine

(8) Codoxime

(9) Desomorphine (dihydrodeoxymorphine)

(10) Diacetylmorphine (heroin)

(11) Dihydrocodeine

(12) Dihydromorphine

(13) Ethylmorphine E/NL.1980/45-48 Page 11

(14) Etorphine

(15) Hydrocodone (dihydrocodeinone)

(16) Hydromorphone (dihydromorphinone)

(17) Hydromorphinol (dihydro-14-hydroxyrnorphine)

(18) Methyldesorphine eoxy-6-methylmorphine)

(19) Methyldihydromorphine (dihydro-6-methylmorphine)

(20) Metopon (dihydromethylraorphinone)

(21) Morphine-N-oxide (morphine-N-oxide)

(22) Myrophine (benzylmorphine myristate)

(23) Nalorphine (N-allylnormorphine)

(24) Nicocodine (6-nicotinylcodeine)

(25) Nicomorphine (dinicotinylmorphine)

(26) Norcodeine

(27) Normorphine

(28) Oxycodone (dihydrohydroxycodeinone)

(29) Oxymorphone (dihydrohydroxymorphinone)

(30) Pholcodine ^-4-morpholinoethylmorphine), and

(31) Thebacon (acetyldihydrocodeinone), but not including:

(32) Apomorphine

(33) Cyprenorphine

(33.1) Naloxone

(34) Narcotine

(35) Papaverine, and

(36) Poppy seed.

2. Coca (Erythroxylon), its preparations, derivatives, alkaloids and salts, including:

(1) Coca leaves

(2) Cocaine, and

(3) Ecgonine (3-hydroxy-2-tropane carboxylic acid).

3. Cannabis sativa, its preparations, derivatives and similar synthetic preparations, including: (1) Cannabis resin

(2) Cannabis (marihuana)

(3) Cannabidiol

(4) Cannabinol (3-n-amyl-6,6,9-trimethy1-6- dibenzopyran-l-ol)

(5) Pyrahexyl (3-n-hexyl-6,6,9-trimethyl-7,8,9,10- tetrahydro-6-dibenzopyran-l-o1), and

(6) Tetrahydrocannabinol.

4. Phenylpiperidines, their preparations, intermediates, derivatives and salts, including:

(1) Allylprodine (3-allyl-l-methy1-4-pheny1-4- piperidyl propionate)

(2) Alphameprodine fc<-3-ethy1-1-methy1-4-pheny1-4- piperidyl propionate)

(3) Alphaprodine (

(4) Anileridine (ethyl l-[2-(p-aminophenyl) ethyl]-4-phenylpiperidine-4-carboxylate)

(5) Betameprodine p^-3-ethy1-1-methy1-4-pheny1-4- piperidyl propionate)

(6) Betaprodine £^-1,3-dimethy1-4-pheny1-4-piperidyl p rop ionate)

(7) Benzethidine (ethyl l-(2-benzyloxyethyl)-4- phenylpiperidine-4-carboxylate)

(8) Diphenoxylate (ethyl l-(3-cyano-3,3-diphenyl- propyl)-4-phenylpiperidine-4-carboxylate)

(9) Etoxeridine (ethyl 1-[2-(2-hydroxyethoxy) ethyl]-4-phenylpiperidine-4-carboxylate)

(10) Fentanyl (1-phenylethyl-4-(phenylproprionyl- amino)-piperidine)

(11) Furethidine (ethyl l-(2-tetrahydrofurfuryl- oxyethyl)-4-phenylpiperidine-4-carboxylate)

(12) Hydroxypethidine (ethyl 4-(m-hydroxyphenyl)-l- raethy1-4-phenylpiperidine-4-carboxylate)

(13) Ketobemidone (1-[4-(m-hydroxyphenyl)-l- methy1-4-piperidyl]-l-propanone)

(14) Methylphenylisonipecotonitrile (4-cyano-l- methy1-4-phenylpiperid ine)

(15) Morpheridine (ethyl l-(2-morpholinoethyl)-4- phenylpiperidine-4-carboxylate) (16) Norpethidine (ethyl 4-phenylpiperidine-4- carboxylate)

(17) Pethidine (ethyl 1-methy1-4-phenylpiperidine-4-carboxylate)

(18) Phenoper id ine (ethy1 l-(3-hydroxy-3-phenyl- propy 1)-4-phenylp iperidine-4-carboxylat e)

(19) Pi mi no d i ne (e thy1 1-[3-(phenylamino)propyl]-4- phenylpiperidine-4-carboxy1ate)

(20) Properidine (isopropyl 1-methy1-4-pheny1- piperidine-4-carboxylate), and

(21) Trimeperidine (1,2-5-trimethy1-4-pheny1-4- piperidyl propionate), but not including

(22) Carbamethidine (ethyl l-(2-carbamylethyl)-4- phenylpiperidine-4-carboxylate)

(2 3) Oxpheneridine (ethyl l-(2-hydroxy-2- phe ny 1 e t hy 1) -4-phe ny lp ip e r id ine -4-c a r b oxy 1 a t e) .

5. Phenazepines, their preparations, derivatives and salts, including:

(1) Proheptazine (hexahydro-1,3-dimethy1-4- pheny 1-4-azepinyl propionate), but not including:

(2) Ethoheptazine (ethyl hexahydro-1-methy1-4- pheny lazepine-4-carboxy late)

(3) Metethoheptazine (ethyl hexahydro-1,3- dimethy1-4-phenylazepine-4-carboxylate), and

(4) Metheptazine (ethyl hexahydro-1,2-dimethy1-4- pheny lazepine-4-'carboxylate) .

6. Amidones, their preparations, intermediates, derivatives and salts, including:

(1) Dimethylaminodiphenylbutanonitrile (4-cyano-2-dimethylamino-4j4-diphenyl butane)

(2) Dipipanone (4,4-diphenyl-6-piperidino-3- heptanone)

(3) Isomethadone (6-dimethylamino-5-methy1-4,4- dipheny1-3-hexanone)

(4) Methadone (6-dimethylaraino-4,4- dipheny1-3-heptanone)

(5) Normethadone (6-dimethylamino-4,4-dipheny1-3- hexanone) , and (6) Phenadoxone (6-morpholino-4,4^diphenyl-3- heptanone)•

7. Methadols, their preparations, derivatives and salt including:

(1) Acetylmethadol (6-dimethylamino-4,4- diphenyl-3~heptanyl acetate)

(2) Alphacetylmethadol (iX-6-dimethylamino-4,4- diphenyl-3-heptanyl acetate) .

(3) Alphamethadol (

(4) Betacetylmethadol (^-6-dimethylamino-4,4- diphenyl-3-heptanyl acetate)

(5) Betamethadol (/$-6-dimethylamino-4,4- dipheny1-3-heptano1)

(6) Dimepheptanol (6-dimethylamino~4,4- diphenyl-3-heptanol), and

(7) Noracymethadol (ot-6-methylamino-4,4- diphenyl-3-heptanyl acetate).

8. Phenalkoxams, their preparations, derivatives and salts, including;

(1) Dimenoxadol (dimethylaminoethyl 1-ethoxy-l,1- diphenylacetate)

(2) Dioxaphetylbutyrate (ethyl 2,2-diphenyl-A- morpholino butyrate), but not including;

(3) Propoxyphene (4-dimethylamino-3-methyl-l,2- diphenyl-2-butyl propionate).

9. Thiambutenes, their preparations, derivatives and salts, including:

(1) Diethylthiambutene (N,N-diethyl-l-methyl-3,3- d i—2-thienylallylamineT (2) Dimethylthiambutene (N,N,l-trimethy1-3,3-dj-2- thienylallylamine), and

(3) Ethylmethylthiambutene (N-ethyl-N,1-dimethyl- 3,3-di-2-thienylallylamine).

10. Moramides, their preparations, intermediates, derivatives and salts, including:

(1) Dextromoramide (d-l-(3-methyl^4-morpholino-2,2- diphenylbutyryl) pyrrolidine) (2) Diphenylmorpholinoisovaleric acid (2-methy1-3-morpholino-l,1-diphenylpropionic ac id)

(3) Levomoramide (l-l-(3-methyl-4-morpholino-2,2- diphenylbutyryl) pyrrolidine), and

(4) Racemoramide (d,l-l-(3-methyl-4-niorpholino-2,2- diphenylbutyryl) pyrrolidine).

11. Morphinans, their preparations, derivatives and salts, including:

(1) Levomethorphan (1-1,2,3,9,10,lOa-hexahydro-6- me thoxy-11-me thy1-4H-10,4a-iminoethanophenanthren e)

(2) Levorphanol (1-1,2,3,9,10,lOa-hexahydro-li• me thy1-4H-10,4a-iminoethanophenanthrene-6-ol)

(3) Levophenacylmorphan (1-1,2,3,9,10,lOa-hexahydro-1l-phenacyl-4H-10,4a-iminoethanophenanthrene-6-ol)

(4) Norlevorphanol (1-1,2,3,9,10,lOa-hexahydro-4H-10,4a-iminoethanophenanthrene-6-o1)

(5) Phenomorphan (d,1-1,2,3,9,10,10a-hexahydro-ll- phenethy1-4H-10,4a-iminoethanophenanthrene-6-o1)

(6) Racemethorphan (d,1-1,2,3,9,10,10a-hexahydro-6- raethoxy-11-methy1-4H-10,4a-iminoethanophenanthrene), and

(7) Racemorphan (d,1-1,2,3,9,10,lOa-hexahydro-li• me thy1-4H-10,4a-iminoethanophenanthrene-6-o1), but not including:

(8) Dextromethorphan (d,1,2,3,9,10,10a-hexahydro-6- me thoxy-11-rae thy1-4H-10,4a-iminoethanophenanthrene)

(9) Dextrorphan (d,1,2,3,9,10,lOa-hexahydro-li• me thy 1-4H-10 ,4a-iminoethanophenanthrene-6-ol)

(10) Levallorphan (l-ll-allyl-1,2,3,9,10,lOa-hexahydro-4H-10,4a-iminoethanophenanthrene-6-ol), and

(11) Levargorphan (l-ll-propargyle-1,2,3,9,10,10a- hexahy dro-4H-10,4a-iminoethanophenanthrene-6-o1)

(12) Butorphanol and its salts.

12. Benzazocines, their preparations, derivatives and salts, including:

(1) Phenazocine (l,2,3,4,5,6-hexahydro-6,ll- dimethyl-3-phenethyl-2,6-methano-3-benzazocin-8-ol), and

(2) Metazocine (l,2,3,4,5,6-hexahydro-3,6,11- trimethy1-2,6-methano-3-benzazocin-8-ol), E/NL.1980/45-48 Page 16

but not including:

(3) Pentazocine (1,2,3,4,5,6-hexahydro-6,11- dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3- benzazocin-8-ol), and

(4) Cyclazocine (1,2,3,4,5,6-hexahydro-6-ll- dime thy1-3-(eye1opropylme thy1)-2,6-rae thano-3- benzazocin-8-o1).

13. Ampromides, their preparations, derivatives and salts, including:

(1) D iampromide (N-[2-(methylphenethylamino)- p ropy1J-prop ionani1id e)

(2) Phenampromide (N-[2-(l-raethyl-2-piperidyl)- ethylT —p rop ionan i1id e)

(3) Propiram (N-(1-methyl-2-piperidinoethyl)-N-2- pyridylpropionamide).

14. Benzimidazoles, their preparations, derivatives and salts, including:

(1) Clonitazene (2-(p-chlorobenzyl)-l-diethyl- aminoethyl-5-nitrobenzimidazole)

(2) Etonitazene (2-(p-ethoxybenzyl)-l-diethylamino- ethyl-5-nitrobenziraadazole).

15. Phencyclidine, its salts and derivatives.

R.S., c. N-l, Sch., SOR/71-226, (359); SI/73-48; SI/77-113.

Office Consolidation E/NL.1980/46 February 1980 NARCOTIC CONTROL REGULATIONS, AMENDED P.C. 1978-444

REGULATIONS RESPECTING THE CONTROL OF NARCOTICS 2/

Short Title

1. These Regulations may be cited as the Narcotic Control Regulations.

Interpretation

2. In these Regulations,

"Act" means the Narcotic Control Act; ("Loi")

"advertisement" means any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of a narcotic; ("arinonce") "hospital" means E/NL.1980/45-48 Page 17

(a) a hospital that is listed or referred to in an agreement with a province made pursuant to the Hospital Insurance and Diagnostic Services Act,

(b) a tuberculosis hospital licensed or approved by a province as a tuberculosis hospital,

(d) a private hospital, a nursing home or a home for convalescent or chronically ill persons that is licensed or approved by a province as such,

(e) a veterinary hospital that is operated by, or is under the direct supervision of, a practitioner, or

(f) any other institution that

(i) is operated primarily for the care or treatment of persons suffering from any form of disease or illness, and

(ii) is approved by the Minister as a hospital for the purpose of these Regulations; ("hSpital")

"inspector" means a person designated by the Minister as an inspector for the purposes of these Regulations; ("inspecteur")

"licence" means a licence issued under section 9; ("licence")

"licensed dealer" means the holder of a licence; ("distributeur autorisfi")

"methadone" includes the salts of methadone; ("metadone")

"Minister" means the Minister of National Health and Welfare; ("Ministre")

"oral prescription narcotic" means medication that

(a) contains in addition to a narcotic two or more medicinal ingredients other than a narcotic in a recognized therapeutic dose, and

(b) is not intended for parenteral administration; ("stupefiant d'ordonnance verbale")

"permit" means a permit issued under section 10; ("permis")

"pharmacist"

(a) means a person who is registered and entitled under the laws of a province

(i) to practise pharmacy, and

(ii) to operate a pharmacy or dispensary

and who is operating a pharmacy or dispensary and is practising pharmacy thereunder in that province, and

(b) includes, for the purposes of section 3, paragraph 27 (8) (a) and sections 31 to 39 and 46, a person who is registered and entitled under the laws of a province to practise pharmacy and who is so practising in that province; ("pharmacien") E/NL.1980/45-48 Page 18

"practitioner" means a person who is registered and entitled under the laws of the province to practise the profession of medicine, dentistry or veterinary medicine,* ("praticien")

"prescription" means a direction given by a practitioner that a stated amount of a specified narcotic be dispensed for the person named therein; ("ordonnance")

"proper name", with reference to a narcotic, means the name internationally recognized for the narcotic or the name assigned to the narcotic in the latest edition of any generally recognized pharmacopoeia or compendium of drugs; ("nora propre")

"test kit" means an apparatus

(a) that contains reagent systems or buffering agents or both,

(b) that is used in the course of a chemical or analytical procedure for medical, laboratory, industrial, educational or research purposes, and

"verbal order" means an order verbally given for a stated amount of a specified narcotic by a person to whom a pharmacist is authorized by these Regulations to sell a narcotic pursuant to a verbal or written order; ("commande verbale")

"written order" means an order, in writing, dated and signed by a person to whom a licensed dealer or a pharmacist is authorized by these Regulations to sell a narcotic pursuant to a written order. ("commande Scrite") S0R/78-154, s. 1.

Possession

3. (1) A person is authorized to have a narcotic in his possession where that person has obtained the narcotic pursuant to these Regulations and

(a) requires the narcotic for his business or profession and is

(i) a licensed dealer,

(ii) a pharmacist, or

(iii) a practitioner who is registered and entitled to practise in the province in which he has such possession;

(b) is a practitioner who is registered and entitled to practise in a province other than the province in which he has such possession and such possession is for emergency medical purposes only;

(d) for his own use

(i) from a practitioner,

(ii) pursuant to a prescription that is not issued or obtained in contravention of these Regulations, or

(iii) from a pharmacist pursuant to section 36;

(e) is a practitioner of medicine who received the narcotic pursuant to subsection 68 (3) or (5) and his possession is for a purpose referred to in subsection 68 (4) or (6); E/NL.1980/45-48 Page 19

(f) is an agent of a practitioner of medicine who received the narcotic pursuant to section 68 (3) and his possession is for the purpose of complying with subsection 68 (5);

(g) is employed as an inspector, a member of the Royal Canadian Mounted Police, a police constable, peace officer or member of the technical or scientific staff of any department of the Government of Canada or of a province or university and such possession is for the purposes of and in connection with such employment;

(h) is a person other than a person referred to in paragraphs (e) or (f), is authorized by section 68 to possess a narcotic and his possession is only for a purpose set out or referred to in the authorization; or

(i) is a person referred to in paragraph 68 (4) (b).

(2) A person acting, for the purpose of possession of a narcotic, as the agent for any person mentioned in subsection (1) is authorized to be in possession of that narcotic.

(3) A person in whose favour a prescription or a narcotic has been issued shall not seek or receive another prescription or a narcotic from a different practitioner without disclosing to that practitioner particulars of every prescription or narcotic that he has obtained within the previous 30 days.

Test Kits Containing Narcotics

4. Any person may sell, possess or otherwise deal in a test kit that contains a narcotic if

(a) a registration number has been issued for the test kit pursuant to section 6;

(b) the test kit bears, on its external surface,

(i) the manufacturer's name,

(ii) the trade name or trade mark, and

(iii) the registration number issued therefor pursuant to section 6;

(c) the test kit is sold, possessed or otherwise dealt in for the purpose of medical, laboratory, industrial, educational or research use; and

(d) the registration number has not been cancelled pursuant to section 7.

5. The manufacturer of a test kit that contains a narcotic may apply for a registration number therefor by submitting to the Director an application containing

(a) particulars of the design and construction of the test kit;

(b) a detailed description of the narcotic and other substances, if any, contained in the test kit, including the qualitative and quantitative composition of each component;

(d) any further information and material that the Minister may require in order to satisfy himself that the test kit is one for which a registration number may be issued. E/NL.1980/45-48 Page 20

6. Where, on application under section 5, the Minister is satisfied that the test kit to which the application applies will only be used for medical, laboratory, industrial, educational or research use and that it

(a) contains a narcotic and one or more adulterating or denaturing agents in such a manner, combination^ quantity, proportion or concentration that the preparation or mixture has no significant drug abuse potential, or

(b) contains such small quantities or concentrations of any narcotic substance as to have no significant drug abuse potential and is a test kit described in the table to this section,

the Minister may issue a registration number for the test kit, which shall be a number preceded by the letters "TK".

TABLE

Column I Column II Column III

Name of Manufacturer Name of Test Kit Form of Product

7. The Minister may cancel the registration number for a test kit if the test kit is removed from the market by the manufacturer or if, in the Minister's opinion,

(a) it is necessary to cancel the registration number in the interest of public health; or

(b) the test kit for which the registration number is issued is used or is likely to be used for any purpose other than medical, laboratory, industrial, educational or research use.

Licences and Licensed Dealers

8. (1) Subject to these Regulations, no person except a licensed dealer shall manufacture, import or export, sell, give, transport, send, deliver or distribute a narcotic.

(2) No licensed dealer may import or export a narcotic without a permit.

9. (1) The Minister may, upon application therefor, issue a licence to any person who, in the opinion of the Minister, is qualified to be a licensed dealer for the sale, manufacture, production and distribution of a narcotic.

(2) An applicant for a licence shall specify in the application the narcotics in respect of which the licence is to apply.

(3) A licensed dealer may only sell, manufacture, produce or distribute the narcotics designated in his licence.

(4) A licensed dealer may at any time make application to the Minister to amend the licence in order to include narcotics other than those specified in the licence.

10. The Minister may, upon application therefor, issue a permit to any licensed dealer for the importation or exportation of a narcotic. E/NL.1980/45-48 Page 21

11. (1) An application for a licence shall be made in a form approved by the Minister and shall, except in the case of an application for or on behalf of

(a) any branch or agency of the Government of Canada or the government of a province or any employee thereof, or

(b) any person or organization engaged in scientific investigations,

be accompanied by a fee of twenty-five dollars.

(2) An application for a permit shall be in a form approved by the Minister. SOR/78-154, s. 2.

12. Every licence or permit issued under these Regulations is subject to the condition that the licensed dealer will comply with the provisions of these Regulations.

13. The Minister may revoke or suspend a licence or permit issued under these Regulations if, in his opinion, the person to whom it was issued has violated or failed to comply with any term or condition thereof or any provision of these Regulations.

14. (1) A licence issued under section 9 expires on December 31st next following the day on which it was issued.

(2) A permit issued under section 10 is valid only for the particular importation or exportation in respect of which it was issued.

15. Every licensed dealer shall keep a record of the following;

(a) the name and quantity of any narcotic received by him, the name and address of the person who supplied it, and the date it was received;

(b) the name, quantity and form of narcotic supplied by him, the name and address of the person to whom it was supplied and the date it was supplied;

(c) the name and quantity of any narcotic used in manufacturing, the name and quantity of any narcotic manufactured and the date any manufactured narcotic was placed in stock; and

(d) the name and quantity of any narcotic in stock at the end of each month.

16. The Minister may, in respect of a licensed dealer, require an inspection of the following to be made at any reasonable time:

(a) the premises used or intended to be used in manufacturing or storing a narcotic;

(b) the process and conditions of the manufacturing or storing;

(d) the records relating to the manufacturing or storing.

17. Every licensed dealer shall

(a) furnish such information respecting the dealings of such person in any narcotic in such form and at such times as the Minister may require;

(b) produce to an inspector any books, records or documents required to be kept by these Regulations; E/NL.1980/45-48 Page 22

(d) permit an inspector to check all stocks of narcotics located on the premises described in the licence of the licensed dealer.

18. Every licensed dealer shall keep in the premises described in the licence full and complete records respecting any narcotic or transaction therein

(a) for a period of at least two years; and

(b) in a manner that will enable an audit to be made at any time of such records.

19. Every licensed dealer shall notify the Minister promptly of changes in the following:

(a) his technical staff;

(b) the premises in which a narcotic is manufactured or stored; and

20. Every licensed dealer shall

(a) provide such protection against loss or theft of any narcotic in his possession as may be required by the Minister; and

(b) report to the Minister any loss or theft of a narcotic within 10 days of his discovery thereof.

21. A licensed dealer may only import into or export out of Canada a narcotic at the place specified in his permit.

22. A licensed dealer shall securely pack in a package sealed in such a manner that it cannot be opened without breaking the seal any narcotic intended for export out of Canada.

23. (1) Except as provided in subsection (2), a licensed dealer shall, in taking delivery of a narcotic imported by him or in making delivery of a narcotic,

(a) take such steps as are necessary to ensure safekeeping of the said narcotic during transit; and

(b) use such method of transportation as will ensure an accurate record being kept of the narcotic and of the signatures of any persons having charge of the narcotic until it is delivered to the consignee.

(2) A licensed dealer may deliver an oral prescription narcotic by common carrier.

24. (1) Subject to subsections (2) and (3) and sections 27 and 28, no licensed dealer shall supply narcotics to any person or institution.

(2) A licensed dealer may supply any narcotic other than methadone to

(a) another licensed dealer;

(b) a pharmacist;

(d) a hospital; E/NL.1980/45-48 Page 23

(e) a person authorized by these Regulations or by the Minister pursuant to subsection 68 (1) to be in possession of that narcotic; or

(f) a Regional Director of the Health Protection Branch.

(3) A licensed dealer may supply methadone to

(a) another licensed dealer;

(b) a pharmacist;

(d) a person authorized by the Minister pursuant to subsection 68 (1) to be in possession thereof. S0R/78-154, s. 3.

25. Subject to section 26 and notwithstanding subsections 24 (2) and (3) and section 36, no licensed dealer shall

(a) supply a narcotic, other than an oral prescription narcotic, to a pharmacist identified in a notice given by the Minister pursuant to section 47;

(b) supply an oral prescription narcotic, other than a preparation mentioned in section 36, to a pharmacist identified in a notice given by the Minister pursuant to section 48;

(c) supply a preparation mentioned in section 36 to a pharmacist identified in a notice given by the Minister pursuant to section 49;

(d) supply a narcotic, other than an oral prescription narcotic, to a practitioner identified in a notice given by the Minister pursuant to section 58; or

(e) supply an oral prescription narcotic to a practitioner identified in a notice given by the Minister pursuant to section 59.

26. Section 25 does not apply to a licensed dealer to whom the Minister has given notice of revocation

(a) pursuant to section 51 in respect of a pharmacist identified in a notice given by the Minister pursuant to section 47, 48 or 49; or

(b) pursuant to section 61 in respect of a practitioner identified in a notice given by the Minister pursuant to section 58 or 59.

27. (1) Subject to this section, a licensed dealer may, in accordance with the terms and conditions of his licence,

(a) supply a narcotic other than methadone to a person or institution referred to in subsection 24 (2), and

(b) supply methadone to a person or institution referred to in subsection 24 (3) if the licensed dealer has, on the premises described in the licence, received

(d) an order sent through a computer from a remote input device, or

(e) a verbal order for oral prescription narcotics that specifies the name and the quantity of the narcotic to be supplied. E/NL.1980/45-48 Page 24

(2) A licensed dealer may supply methadone to a hospital on a written order or an order sent through a computer from a remote input device from any practitioner if the practitioner is named in an authorization issued by the Minister pursuant to subsection 68 (1).

(3) Where a licensed dealer has received a written order referred to in paragraph (1) (c), he may supply

(a) a narcotic other than methadone to a person or institution referred to in subsection 24 (2), and

(b) methadone to a person or institution referred to in subsection 24 (3) if

(i) by the person to whom the narcotic is to be supplied, or

(ii) in the case of an order made on behalf of a hospital, by the •.pharmacist in charge of the dispensary of the hospital or by a practitioner authorized by the hospital to sign the order on its behalf; and

(d) the signature referred to in paragraph (c), if unknown to the licensed dealer, is verified.

(4) A licensed dealer may supply a narcotic pursuant to an order received from a remote input device through a computer if the computer program and the remote input device meet the requirements thereof set out in subsections (6) and (7).

(5) Where a licensed dealer has received a verbal order referred to in paragraph (1) (e), he may supply an oral prescription narcotic to a person or institution referred to in paragraphs 24 (2) (b) to (d) if he forthwith records

(a) the name of the person to whom the oral prescription narcotic is to be supplied;

(b) in the case of an order made for or on behalf of a hospital, the name of the pharmacist in charge of the dispensary or the name of a practitioner authorized by the hospital to sign such an order on its behalf; and

.(c) the date that the order is received.

(6) For the purposes of this section, a remote input device shall be a device for transmitting electronically orders for drugs, other than by voice communication, that

(a) contains a unique identifying code that can be related to the device and the pharmacist or practitioner in whose possession and care the remote input device has been placed;

(b) is in the possession and care of that pharmacist or practitioner; and

(c) is designed in such a way that the unique identifying code for the remote input device is an integral part of the circuitry and can only be modified by the dismantling of the device.

(7) For the purposes of this section, a computer program shall be able to

(a) identify the remote input device, the name and address of the pharmacist or practitioner in whose possession and care the remote input device has been placed; E/NL.1980/45-48 Page 25

(b) identify the pharmacist or practitioner placing the order by means of a code unique to that pharmacist or practitioner;

(d) detect unusual orders and thereby necessitate intervention by the licensed dealer; and

(e) necessitate manual intervention by the licensed dealer if one or more of the check procedures fails.

(8) Where a licensed dealer has received a verbal order or an order sent from a remote input device through a computer from a pharmacist or practitioner, he shall, within five working days of filling the order for a narcotic, obtain and keep a receipt that includes

(a) the signature of the pharmacist or practitioner who received the narcotic;

(b) the date the pharmacist or practitioner received the narcotic; and

(9) Where a licensed dealer does not receive, within the time stipulated in subsection (8), a receipt as required from the pharmacist or practitioner who placed the order, he shall not, until such time as he receives the receipt, supply any narcotic pursuant to any further verbal order or order sent from a remote input device from such pharmacist or practitioner. SOR/78-154, s. 4.

28. (1) No licensed dealer shall supply a narcotic unless the main label of the container in which it is supplied bears, legibly and conspicuously,

(a) the proper name of the narcotic, if any, and where there is a proprietary or brand name, the proper name shall immediately proceed or follow the said proprietary name in type of not less than one-half the size of the proprietary or brand name;

(b) if there is no proper name, the common name;

(c) the name of the manufacturer and, if the narcotic is manufactured or produced outside Canada, the name of the distributor in Canada;

(d) the Symbol "N" on the upper left-hand quarter thereof in a colour contrasting with the rest of the label or in type not less than half the size of any other letters used thereon;

(e) a correct statement of the net contents of the container in terms of weight, measure or number;

(f) in the case of a narcotic not in combination with other medicinal ingredients,

(i) if the narcotic is in tablet, capsule, ampoule or other such form, the narcotic content per tablet, capsule, ampoule or other such form, or

(ii) if the narcotic is in any other form, the narcotic content per unit of weight, measure or number specified on the label; and

(g) in the case of a narcotic in combination with any other medicinal ingredients, a quantitative list of all medicinal ingredients therein per specified unit. E/NL.1980/45-48 Page 26

(2) No licensed dealer shall supply a narcotic, other than a preparation described in section 36, unless it is securely packed in its immediate container and sealed in such a manner that it cannot be opened, without breaking the seal.

29. Section 28 does not apply to a test kit that contains a narcotic where a registration number has been issued for the test kit pursuant to section 6 and has not been cancelled pursuant to section 7.

Pharmacists

30. A pharmacist, upon receipt of a narcotic from a licensed dealer or from another pharmacist as provided in section 45, shall forthwith enter in a book, register or other record maintained for such purposes, the following:

(a) the name and quantity of the narcotic received;

(b) the date the narcotic was received; and

31. (1) Subject to subsections (2) and (3) and sections 34 to 36, no pharmacist shall supply a narcotic to any person or institution.

(2) A pharmacist may supply a narcotic other than methadone to a person if the pharmacist has first received a written order or prescription therefor signed and dated by a practitioner and the signature of the practitioner, where not known to the pharmacist, has been verified by him.

(3) A pharmacist may supply methadone to

(a) a licensed dealer;

(b) another pharmacist;

(d) a person authorized by the Minister pursuant to subsection 68 (1); or

(e) a person from whom the pharmacist has received a written order or prescription therefor signed and dated by a practitioner of medicine who is authorized by the Minister pursuant to subsection 68 (1).

32. Subject to section 33 and notwithstanding subsections 31 (2) and (3) and sections 34 to 36, no pharmacist shall

(a) supply a narcotic, other than an oral prescription narcotic, to a pharmacist identified in a notice given by the Minister pursuant to section 47;

(b) supply an oral prescription narcotic, other than a preparation mentioned in section 36, to a pharmacist identified in a notice given by the Minister pursuant to section 48;

(c) supply a preparation mentioned in section 36 to a pharmacist identified in a notice given by the Minister pursuant to section 49;

(d) dispense or supply a narcotic, other than an oral prescription narcotic, to a practitioner or pursuant to a prescription or order given by a practitioner identified in a notice given by the Minister pursuant to section 58; or E/NL.1980/45-48 Page 27

(e) dispense or supply an oral prescription narcotic to a practitioner or pursuant to a prescription or order given by a practitioner identified in a notice given by the Minister pursuant to section 59.

33. Section 32 does not apply to a pharmacist to whom the Minister has given notice of revocation

(a) pursuant to section 51 in respect of a pharmacist identified in a notice given by the Minister pursuant to section 47, 48 or 49; or

(b) pursuant to section 61 in respect of a practitioner identified in a notice given by the Minister pursuant to section 58 or 59.

34. Subject to section 39, a pharmacist may dispense an oral prescription narcotic other than methadone upon prescription or order given verbally by a person whom the pharmacist has taken reasonable precautions to determine is a practitioner.

35. (1) A pharmacist may supply any narcotic other than methadone to a hospital and may, subject to subsection (2), supply methadone to a hospital upon a written order from

(a) the pharmacist in charge of the dispensary of the hospital, or

(b) a practitioner authorized by the hospital to sign the order on its behalf, if the signature of that pharmacist or practitioner, if unknown, has been verified.

(2) No pharmacist shall supply methadone to a hospital upon a written order from any practitioner who is not named in an authorization issued by the Minister pursuant to subsection 68 (1).

36. (1) A pharmacist may, without a prescription, supply a preparation containing not more than 8 milligrams or its equivalent of codeine phosphate per tablet or per unit in other solid form or not more than 20 milligrams or its equivalent of codeine phosphate per 30 millilitres in a liquid preparation, if

(a) the preparation contains

(i) two additional medicinal ingredients other than a narcotic in a quantity of not less than the regular minimum single dose for one such ingredient or one-half the regular minimum single dose for each such ingredient, or

(ii) three additional medicinal ingredients other than a narcotic in a quantity of not less than the regular minimum single dose for one such ingredient or one-third the regular minimum single dose for each such ingredient; and

(b) there is legibly and conspicuously printed on the main panel of the label and on any outer container the full formula or true list of all active ingredients and a caution to the following effect:

"This preparation contains codeine and should not be administered to children except on the advice of a physician".

(2) No pharmacist shall sell a preparation mentioned in subsection (1) where there are reasonable grounds for believing that the preparation will be used by a person for other than recognized medical or dental purposes. S0R/78-154, s. 5.

37. A pharmacist shall not use an order or prescription, written or verbal, to dispense a narcotic on more than one occasion. E/NL.1980/45-48 Page 28

38. A pharmacist shall forthwith after dispensing a narcotic, other than an oral prescription' narcotic, pursuant to a written order or prescription, enter in a book, register or other record maintained for such purposes

(a) the name and address of the person named in the order or prescription;

(b) the name, quantity and form of the narcotic;

(d) the name or initials of the pharmacist who supplied the narcotic;

(e) the date the narcotic was supplied; and

(f) the number assigned to the order or prescription.

39. A pharmacist shal'l'i before dispensing an oral prescription narcotic pursuant to an order or prescription verbally given therefor, make a written record thereof, setting forth

(a) the name and address of the person named therein;

(b) in accordance with the manner in which it is specified in the prescription, the name and quantity of such oral prescription narcotic or the narcotic and the other medicinal ingredients therein;

(d) the name, initials and address of the practitioner who issued the order or prescription;

(e) the name or initials of the pharmacist who dispensed such oral prescription narcotic;

(f) the date such oral prescription narcotic was supplied; and

(g) the number assigned to the order or prescription.

40. (1) A pharmacist shall; maintain a special narcotic prescription file in which shall be filed in sequence as to date and number all written orders or prescriptions for narcotics dispensed and the written record of all oral prescription narcotics dispensed pursuant to an order or prescription verbally given as provided in section 39.

(2) A pharmacist shall retain in his possession for a period of at least two years any records which he is required to keep by these regulations.

41. A pharmacist shall

(a) furnish such information respecting the dealings of the pharmacist in any narcotic in such form and at such times as the Minister may require;

(b) make available and produce to an inspector upon request his special narcotic prescription file together with any books, records or documents which he is required to keep;

(d) permit an inspector to check all stocks of narcotics on his premises. E/NL.1980/45-48 Page 29

42. A pharmacist shall report to the Minister any loss or theft of a narcotic within 10 days of his discovery thereof.

43. A pharmacist shall keep all narcotics except oral prescription narcotics securely in a locked receptacle, drawer or safe.

44. (1) No pharmacist shall prepare a narcotic unless the Minister has approved the formula thereof, and if such narcotic is a preparation described in section 36, has approved the label and the size of the container in which it will be sold.

(2) A pharmacist who prepares a narcotic shall, in addition to all other records required to be kept, keep a record of the following:

(a) the kind and quantity of any narcotic used in the preparation;

(b) the name and quantity of the narcotic prepared; and

(3) For the purposes of this section, "prepare" does not include the compounding of a narcotic pursuant to a prescription of a practitioner.

45. (1) A pharmacist may

(a) upon receiving a written order from a licensed dealer who supplied a narcotic to him, return the narcotic to the dealer; or

(b) upon receiving a written order from a pharmacist, supply to the pharmacist such quantities of a narcotic as are specified in the order for emergency needs or purposes.

(2) A pharmacist shall forthwith after supplying a narcotic registered under subsection (1) enter the details of the transaction in a book, record or other register maintained for the purpose of recording such transactions.

(3) A pharmacist shall forthwith after removing, transporting or transferring a narcotic from his place of business to any other place of business operated by him notify the Minister setting out the details thereof.

46. The Minister may, in any of the circumstances described in paragraphs 50 (a) to (f), communicate to the appropriate provincial authority of the province in which a pharmacist is registered and entitled to practise pharmacy information with respect to the pharmacist obtained under these Regulations together with any other information he considers relevant.

47. The Minister

(a) shall, in the circumstance described in subparagraph 50 (a) (i), and

(b) may, in the circumstance described in subparagraph 50 (b) (i) or paragraph 50 (c) or (d), after consultation with the licensing authority of the province in which the pharmacist is registered and entitled to practise pharmacy, give notice to licensed dealers and pharmacists of the name and address of the pharmacist to whom the circumstance is applicable.

48. The Minister

(a) shall, in the circumstance described in subparagraph 50 (a) (ii), and E/NL.1980/45-48 Page 30

(b) may, in the circumstance described in subparagraph 50 (b) (ii) or paragraph 50 (c) or (e), after consultation with the licensing authority of the province in which the pharmacist is registered and entitled to practise pharmacy,

give notice to licensed dealers and pharmacists of the name and address of the pharmacist to whom the circumstance is applicable.

49. The Minister

(a) shall, in the circumstance described in subparagraph 50 (a) (iii), and

(b) may, in the circumstance described in subparagraph 50 (b) (iii) or paragraph 50 (f), after consultation with the licensing authority of the province in which the pharmacist is registered and entitled to practise pharmacy,

give notice to licensed dealers and pharmacists of the name and address of the pharmacist to whom the circumstance is applicable.

50. For the purposes of sections 46 to 49, the circumstances described in this section are as follows:

(a) a pharmacist has made a written request to the Minister that a notice be given by the Minister to licensed dealers and pharmacists setting out the pharmacist's name and address and stating that

(i) no narcotic, other than an oral prescription narcotic, should be supplied to him,

(ii) no oral prescription narcotic, other than a preparation mentioned in section 36, should be supplied to him, or

(iii) no preparation mentioned in section 36 should be supplied to him;

(b) a pharmacist has violated a rule of conduct of the appropriate licensing authority of the province in which he is registered and entitled to practise pharmacy and that authority has made a written request to the Minister that a notice be given by the Minister identifying him pursuant to

(i) section 47,

(ii) section 48, or

(iii) section 49;

(d) a pharmacist is unable to demonstrate that all narcotics other than oral prescription narcotics purchased or obtained by him have been furnished by him in accordance with these Regulations;

(e) a pharmacist is unable to demonstrate that all oral prescription narcotics, other than a preparation mentioned in section 36, purchased or obtained by him have been furnished by him in accordance with these Regulations; and

(f) a pharmacist has violated any of the provisions of section 30, subsection 36 (2) or paragraph 70 (c).

51. Where the Minister has given notice pursuant to section 47, 48 or 49 of the name and address of a pharmacist and the circumstances described in section 52 have occurred, E/NL.1980/45-48 Page 31 the Minister shall give notice of revocation of that notice in respect of that pharmacist to licensed dealers and pharmacists.

52. For the purposes of section 51, the circumstances described in this section are as follows:

(a) a pharmacist and the appropriate licensing authority of the province in which that pharmacist is registered and entitled to practise pharmacy have made a written request to the Minister that the Minister revoke the notice given by the Minister identifying the pharmacist pursuant to

(i) section 47,

(ii) section 48, or

(iii) section 49; and

(b) one year has elapsed since the notice referred to in paragraph (a) was given by the Minister.

Practitioners

53. (1) No practitioner shall administer, prescribe, give, sell or furnish a narcotic to any person or animal except as provided in this section.

(2) Subject to subsection (3), a practitioner may administer, prescribe, give, sell or furnish a narcotic to a person or animal if

(a) the person or animal is a patient under his professional treatment; and

(b) the narcotic is required for the condition for which the person or animal is receiving treatment.

(3) No practitioner shall administer, prescribe, give, sell or furnish methadone to any person or animal unless the practitioner has been named in an authorization issued by the Minister pursuant to subsection 68 (1).

54. (1) A practitioner who furnishes a narcotic to a person for self-administration or for administration to an animal shall, whether or not he makes a charge therefor, if he furnishes the narcotic in an amount

(a) that exceeds three times the maximum daily dosage recommended by the manufacturer of that narcotic for that narcotic, or

(b) if the manufacturer has not recommended a maximum daily dosage, that exceeds three times the generally recognized maximum daily therapeutic dosage for that narcotic keep a record showing

(d) the name and address of the person to whom it was furnished, and

(e) the date on which it was furnished.

(2) A practitioner who is required by this section to keep a record shall keep the record in a place, form and manner that will permit an inspector readily to examine and obtain information from it. E/NL.1980/45-48 Page 32

55. A practitioner shall

(a) furnish to the Minister on request such information respecting

(i) the receipt and use by the practitioner of narcotics (including the administering and furnishing thereof to a person), and

(ii) the prescriptions for narcotics issued by the practitioner, as the Minister may require;

(b) produce to an inspector on request any records that these Regulations require the practitioner to keep;

(d) permit an inspector to check all stocks of narcotics on the practitioner's premises;

(e) retain in his possession for at least two years any record that these Regulations require him to keep;

(f) take adequate steps to protect narcotics in his possession from loss or theft; and

(g) report to the Minister any loss or theft of a narcotic within 10 days of the practitioner's discovery of the loss or theft.

56. Where a practitioner alleges or* in any prosecution for an offence under the Act or these Regulations, pleads that his possession of a narcotic was for use in his practice or that he prescribed, administered, gave, sold or furnished a narcotic to any person or animal as a patient under his professional treatment and that such narcotic was required for the condition for which the patient received treatment, the burden of proof thereof shall be On such practitioner.

57. The Minister may, in any of the circumstances described in paragraphs 60 (a) to (i), communicate to the appropriate licensing authority of the province in which a practitioner is registered and entitled to practise information with respect to the practitioner obtained under these Regulations together with any other information he considers relevant.

58. The Minister

(a) shall, in the circumstance described in subparagraph 60 (a) (i), and

(b) may, in the circumstance described in subparagraph 60 (b) (i) or paragraph 60 (c), (d), (e) or (f), after consultation with the licensing authority of the province in which the practitioner is registered and entitled to practise give notice to licensed dealers and pharmacists of the name and address of the practitioner to whom the circumstance is applicable.

59. The Minister

(a) shall, in the circumstance described in subparagraph 60 (a) (ii), and

(b) may, in the circumstance described in subparagraph 60 (b) (ii) or paragraph 60 (c), (g), (h) or (i), after consultation with the licensing authority of the province in which the practitioner is registered and entitled to practise E/NL.1980/45-48 Page 33 give notice to licensed dealers and pharmacists of the name and address of the practitioner to whom the circumstance is applicable.

60. For the purposes of sections 57 to 59, the circumstances, described in this section are as follows:

(a) a practitioner has made a written request to the Minister that a notice be given by the Minister to licensed dealers and pharmacists setting out the practitioner's name and address and stating that

(i) no narcotic, other than an oral prescription narcotic, should be supplied to him, or

(ii) no oral prescription narcotic should be supplied to him;

(b) a practitioner has violated a rule of conduct of the appropriate licensing authority of the province in which he is registered and entitled to practise and that authority has made a written request to the Minister that a notice be given by the Minister identifying the practitioner pursuant to

(i) section 58, or

(ii) section 59;

(d) a practitioner has repeatedly administered a narcotic, other than an oral prescripton narcotic, to himself on his own prescription or order other than in accordance with normal or accepted medical or dental practice;

(e) a practitioner has repeatedly prescribed, furnished or administered a narcotic, other than an oral prescription narcotic, to his spouse, parent or child for other than normal or accepted medical or dental use;

(f) a practitioner is unable to demonstrate that all narcotics, other than oral prescription narcotics, purchased or obtained by him have been used or otherwise dealt with by him in accordance with these Regulations after the Minister has made a request pursuant to paragraph 55 (a);

(g) a practitioner has repeatedly administered an oral prescription narcotic to himself on his own prescription or order other than in accordance with normal or accepted medical or dental practice;

(h) a practitioner has repeatedly prescribed, furnished or administered an oral prescription narcotic to his spouse, parent or child for other than normal or accepted medical or dental use; and

(i) a practitioner is unable to demonstrate that all oral prescription narcotics purchased or obtained by him have been used or otherwise dealt with by him in accordance with these Regulations after the Minister has made a request pursuant to paragraph 55 (a).

61. Where the Minister has given notice pursuant to section 58 or 59 of the name and address of a practitioner and the circumstances described in section 62 have occurred, the Minister shall give notice of revocation of that notice in respect of that practitioner to licensed dealers and pharmacists.

62. For the purposes of section 61, the circumstances described in this section are as follows: E/NL.1980/45-48 Page 34

(a) a practitioner and the appropriate licensing authority of the province in which the practitioner is registered and entitled to practise have made a written request to the Minister that the Minister revoke the notice given by the Minister identifying the practitioner pursuant to section 58 or 59; and

(b) one year has elapsed since the notice referred to in paragraph (a) was given by the Minister.

Hospitals

63. A person who is in charge of a hospital shall

(a) keep or cause to be kept in a book, register or other record maintained for such purposes,

(i) the name and quantity of any narcotic received,

(ii) the name and address of the person from whom any narcotic was received and the date received,

(iii) the name and quantity of any narcotic used in manufacturing,

(iv) the name and quantity of any narcotic manufactured and the date of manufacture,

(v) the name of the patient for whom a narcotic other than an oral prescripton narcotic was dispensed,

(vi) the name of the practitioner ordering or prescribing a narcotic other than an oral prescription narcotic, and

(vii) the date a narcotic other than an oral prescription narcotic was ordered or prescribed and the form and quantity thereof;

(b) maintain the recorded information in such form as to enable an audit to be made from time to time for a period of not less than two years from the making thereof;

(c) take all necessary steps to protect narcotics in the hospital against loss or theft, and report to the Minister any loss or theft of narcotics within 10 days of his discovery thereof.

64. A person who is in charge of a hospital shall

(a) furnish such information respecting the use of narcotics therein, in such form and at such times as the Minister may require;

(b) produce to an inspector any books, records or documents required by these Regulations to be kept;

(d) permit an inspector to check all stocks of narcotics in the hospital.

65. (1) No person in charge of a hospital shall permit a narcotic to be dispensed or administered except as provided in this section.

(2) A person in charge of a hospital may permit a narcotic other than methadone to be dispensed or administered E/NL.1980/45-48 Page 35

(a) to a person or animal under treatment as an in-patient or out-patient; and

(b) upon the written order or prescription of a practitioner.

(3) A person in charge of a hospital may permit methadone to be dispensed or administered

(a) to a person or animal under treatment as an in-patient or out-patient; and

(b) upon the written order or prescription of a practitioner named in an authorization issued by the Minister pursuant to subsection 68 (1).

General

66. The Minister may designate any person as an inspector for the purposes of these Regulations.

67. The Minister may, upon application therefor, issue a licence to any person who, in the opinion of the Minister, is qualified therefor, to cultivate, gather or produce opium poppy or marihuana for scientific purposes on such terms and conditions as the Minister deems necessary.

68. (1) Where he deems it to be in the public interest, or in the interests of science, the Minister may in writing authorize

(a) any person to possess a narcotic,

(b) any person to administer a narcotic to an animal,

(c) notwithstanding section 53, any practitioner of medicine to administer, give, furnish, distribute or deliver a narcotic to any person authorized pursuant to paragraph (a) to possess a narcotic, and

(d) any practitioner to administer, prescribe, give, sell or furnish methadone to a person or animal who is a patient under his professional treatment,

for the purposes and subject to the conditions in writing set out or referred to in the authorization.

(2) The Minister may, at any time, revoke the authorization referred to in subsection (1) and require any person in possession of a narcotic pursuant to that authorization to deliver the narcotic to the Minister or his agent.

(3) Notwithstanding anything in these Regulations, a person may, for the purpose of identification or analysis thereof, give or deliver a narcotic that he has in his possession to

(a) a practitioner of medicine, or

(b) an agent of that practitioner which agent has been authorized by the Minister pursuant to subsection (1) to be in possession of that narcotic.

(4) A practitioner of medicine who has received a narcotic pursuant to subsection (3) shall forthwith

(a) for the purpose of identification or analysis thereof, give or deliver that narcotic to a person authorized by the Minister pursuant to subsection (1) to be in possession of that narcotic for that purpose; or

(b) deliver that narcotic to the Minister or his agent. E/NL.1980/45-48 Page 36

(5) An agent of a practitioner of medicine who has received a narcotic pursuant to subsection (3) shall forthwith give or deliver that narcotic

(a) to the practitioner of whom he is the agent, or

(b) to the Minister or his agent.

(6) A practitioner of medicine who has received, pursuant to subsection (5), a narcotic from his authorized agent shall forthwith

(b) deliver that narcotic to the Minister or his agent.

69. Every person who is authorized by the Minister pursuant to subsection 68 (1) to be in possession of a narcotic, other than a person to whom a narcotic has been administered, given, furnished, distributed or delivered by a practitioner of medicine under paragaph 68 (1) (c), every practitioner of medicine who has received a narcotic pursuant to subsection 68 (3) or (5) and every agent of a practitioner of medicine who has received a narcotic pursuant to subsection 68 (3) shall

(a) keep a record of

(i) the kind, date and quantity of any narcotic purchased or received by him,

(ii) the name and address of the person from whom the narcotic was received, and

(iii) particulars of the use to which the narcotic was put; and

(b) furnish such information respecting such narcotics as the Minister may require, and shall permit access to the records required to be kept by these Regulations.

70. No person shall

(a) publish or cause to be published or furnish any advertisement respecting a narcotic unless the symbol "N" is clearly and conspicuously displayed in the upper left-hand quarter thereof or, if the advertisement consists of more than one page, on the first page thereof;

(b) publish or cause to be published or furnish any advertisement to the general public respecting a narcotic; or

71. Any person who violates any provision of these Regulations is guilty of an offence and is liable on summary conviction to a fine not exceeding $500 or to a term of imprisonment not exceeding six months, or to both.

72. (1) For the purposes of subsection 10 (5) of the Act, notification shall be given to the Crown in writing by registered mail addressed to the Minister of National Health and Welfare at Ottawa.

(2) The notice referred to in subsection (1) shall be mailed at least 15 clear days prior to the date the application will be made to the magistrate and shall specify E/NL.1980/45-48 Page 37

(a) the magistrate to whom the application will be made;

(b) the time and place where the application will be heard;

(d) the evidence upon which the applicant intends to rely to establish that he is entitled to possession of the narcotic or other thing referred to in paragraph (c).

Office Consolidation E/NL.1980/47 February 1980

FOOD AND DRUGS ACT 3/ Amended by 1976-77, c. 28 CHAPTER F-27 AN ACT RESPECTING FOOD, DRUGS, COSMETICS AND THERAPEUTIC DEVICES

Short Title

1. This Act may be cited as the Food and Drugs Act. Short title 1952-53, c. 38, s. 1.

Interpretation

2. In this Act Definitions

"advertisement" includes any representation by any means "a dvert i seme nt" whatever for the purpose of promoting directly or "annonce" indirectly the sale or disposal of any food, drug, cosmetic or device;

"analyst" means any person designated as a Food and Drug "analyst" Analyst under subsection 25 (3); "analyste"

"contraceptive device" means "contraceptive device" "produit ..."

(a) any instrument, apparatus or contrivance, and

(b) any substance not being a drug,

that is manufactured, sold or represented for use in the prevention of conception;

[...] "Department" means the Department of National Health and "Department" Welfare; "ministere"

"device" means any article, instrument, apparatus or "device" contrivance, including any component, part or "instrument" accessory thereof, manufactured, sold or represented for use in

(a) the diagnosis, treatment, mitigation or preven• tion of a disease, disorder or abnormal physical state, or the symptoms thereof, in man or animal, E/NL.1980/45-48 Page 38

(b) restoring, correcting or modifying a body function or the body structure of man or animal,

(d) the care of humans or animals during pregnancy and at and after birth of the offspring, including care of the offspring,

and includes a contraceptive device but does not include a drug;

"drug" "drug" includes any substance or mixture of substances "drogue" manufactured, sold or represented for use in

(a) the diagnosis, treatment, mitigation or preven• tion of a disease, disorder, abnormal physical state, or the symptoms thereof, in man or animal,

(b) restoring, correcting or modifying organic functions in man or animal, or

(c) disinfection in premises in which food is manu• factured, prepared or kept, or for the control of vermin in such premises;

"food" "food" includes any article manufactured, sold or "substance .. ." represented for use as food or drink for man, chewing gum, and any ingredient that may be mixed with food for any purpose whatever;

"inspector" "inspector" means any person designated as a Food and Drug "inspecteur" Inspector under subsection 25 (4);

"label" "label" includes any legend, word or mark attached to, "Etiquette" included in, belonging to or accompanying any food, drug, cosmetic, device or package;

"Minister" "Minister" means the Minister of National Health and "Ministre" Welfare;

"package" "package" includes any thing in which any food, drug, "colis" cosmetic or device is wholly or partly contained, placed or packed;

"prescribed" "prescribed" means prescribed by the regulations; "prescri t"

"sell" "sell" includes sell, offer for sale, expose for sale, "vend re" have in possession for sale, and distribute;

"unsanitary conditions" "unsanitary conditions" means such conditions or "conditions ..." circumstances as might contaminate a food, drug or cosmetic with dirt or filth or render the same injurious to health. 1952-53, c. 38, s. 2; 1968-69, c. 41, s. 1. E/NL.1980/45-48 Page 39

PART I FOODS, DRUGS, COSMETICS AND DEVICES

General

3. (1) No person shall advertise any food, drug, cos• Prohibited advertising metic or device to the general public as a treatment, pre• ventative or cure for any of the diseases, disorders or abnormal physical states mentioned in Schedule A.

(2) No person shall sell any food, drug, cosmetic Idem or device

(a) that is represented by label, or

(b) that he advertises to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states mentioned in Schedule A.

[-.-] Drugs

8. No person shall sell any drug that Prohibited sales of drugs (a) was manufactured, prepared, preserved, packed or stored under unsanitary conditions; or

(b) is adulterated. 1952-53, c. 38, s. 8.

9. (1) No person shall lable, package, treat, process, Deception sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.

(2) A drug that is not labelled or packaged as Idem required by the regulations, or is labelled or packaged contrary to the regulations, shall be deemed to be labelled or packaged contrary to subsection (1). 1952-53, c. 38, s. 9.

10. (1) Where a standard has been prescribed for a drug, Where standard no person shall label, package, sell or advertise any prescribed substance in such a manner that it is likely to be mistaken for such drug, unless the substance complies with the prescribed standard.

(2) Where a standard has not been prescribed for a Trade standards drug, but a standard for the drug is contained in any publication mentioned in Schedule B, no person shall lable, package, sell or advertise any substance in such a manner that it is likely to be mistaken for such drug, unless the substance complies with such standard.

(3) Where a standard for a drug has not been prescribed Professed standards and no standard for the drug is contained in any publication mentioned in Schedule B, no person shall sell such drug, unless E/NL.1980/45-48 Page 40

(a) it is in accordance with the professed standard under which it is sold, and

(b) it does not resemble, in a manner likely to deceive, any drug for which a standard has been prescribed or is contained in any publication mentioned in Schedule B. 1952-53, c. 38, s. 10.

Unsanitary conditions 11. No person shall manufacture, prepare, preserve, package or store for sale any drug under unsanitary conditions. 1952-53, c. 38, s. 11.

Indicating safe 12. No person shall sell any drug described in Schedule C conditions or D unless the Minister has, in prescribed form and manner, indicated that the premises in which the drug was manufactured and the process and conditions of manufacture therein are suitable to ensure that the drug will not be unsafe for use. 1952-53, c. 38, s. 12.

Idem 13. No person shall sell any drug described in Schedule E unless the Minister has, in prescribed form and manner, indicated that the batch from which the drug was taken is not unsafe for use. 1952-53, c. 38, s. 13.

Samples 14. (1) No person shall distribute or cause to be distributed any drug as a sample.

Exception (2) Subsection (1) does not apply to the distribution, under prescribed conditions, of samples of drugs to physicians, dentists, veterinary surgeons or pharmacists. 1952-53, c. 38, s. 14; 1962-63, c. 15, s. 1.

Sale prohibited 15. No person shall sell any drug described in Schedule F. 1962-63, c. 15, s. 2.

[...] PART II ADMINISTRATION AND ENFORCEMENT

Powers of Inspectors

Powers of inspectors 22. (1) An inspector may at any reasonable time

(a) enter any place where on reasonable grounds he believes any article to which this Act or the regulations apply is manufactured, prepared, preserved, packaged or stored, examine any such article and take samples thereof, and examine anything that he reasonably believes is used or capable of being used for such manufacture, preparation, preservation, packaging or storing;

(b) open and examine any receptacle or package that on reasonable grounds he believes contains any article to which this Act or the regulations apply; E/NL.1980/45-48 Page 41

(c) examine any books, documents or other records found in any place mentioned in paragraph (a) that on reasonable grounds he believes contain any information relevant to the enforcement of this Act with respect to any article to which this Act or the regulations apply and make copies thereof or extracts therefrom; and

(d) seize and detain for such time as may be necessary any article by means of or in relation to which he reasonably believes any provision of this Act or the regulations has been violated.

(2) For the purposes of subsection (1), the expression Definition "article to which this Act or the regulations apply" includes

(a) any food, drug, cosmetic or device,

(b) anything used for the manufacture, preparation, preservation, packaging or storing thereof, and

(3) An inspector shall be furnished with a Certificate of prescribed certificate of designation and on entering any appointment place pursuant to subsection (1) shall if so required produce the certificate to the person in charge thereof.

(4) The owner or person in charge of a place entered Assistance to inspector by an inspector pursuant to subsection (1) and every person found therein shall give the inspector all reasonable assistance in his power and furnish him with such information as he may reasonably require.

(5) No person shall obstruct an inspector in the Obstructing inspector carrying out of his duties under this Act or the regulations.

(6) No person shall knowingly make any false or False statements misleading statement either verbally or in writing to any inspector engaged in carrying out his duties under this Act or the regulations.

(7) No person shall remove, alter or interfere in Interference any way with any article seized under this Act without the authority of an inspector.

(8) Any article seized under this Act may at the Storing of seized option of an inspector be kept or stored in the building articles or place where it was seized' or may at the direction of an inspector be removed to any other proper place. 1952-53, c. 38, s. 21.

Forfeiture

23. (1) An inspector shall release any article seized by Release of seized him under this Act when he is satisfied that all the articles provisions of this Act and the .regulations with respect thereto have been complied with. (2) Where an inspector has seized an article under this Act and the owner thereof or the person in whose possession the article was at the time of seizure consents to the destruction thereof, the article is thereupon forfeited to Her Majesty and may be destroyed or otherwise disposed of as the Minister or the Minister of Consumer and Corporate Affairs may direct.

(3) Where a person has been convicted of a violation of this Act or the regulations, the court or judge may order that any article by means of or in relation to which the offence was committed or anything of a similar nature belonging to or in the possession of the accused or found with such article, be forfeited, and upon such order being made, such articles and things are forfeited to Her Majesty and may be disposed of as the Minister or the Minister of Consumer and Corporate Affairs may direct.

(4) Without prejudice to the operation of subsection (3), a judge of a superior, county or district court of the province in which any article was seized under this Act may, on the application of an inspector and on such notice to such persons as the judge directs, order that the article and anything of a similar nature found therewith be forfeited to Her Majesty to be disposed of as the Minister or the Minister of Consumer and Corporate Affairs may direct, if the judge finds, after making such inquiry as he considers necessary, that the article is one by means of or in relation to which any of the provisions of this Act or the regulations were violated. 1952-53, c. 38, s. 22; 1968-69, c. 28, s. 105.

Analysis

24. (1) An inspector may submit any article seized by him or any sample therefrom or any sample taken by him to an analyst for analysis or examination.

(2) Where an analyst has made an analysis or examination he may issue a certificate or report setting forth the results of his examination or analysis. 1952-53, c. 38, s. 23.

Regulations

25. (1) The Governor in Council may make regulations for carrying the purposes and provisions of this Act into effect, and, in particular, but not so as to restrict the generality of the foregoing, may make regulations

(a) declaring that any food or drug or class of food or drugs is adulterated if any prescribed substance or class of substances is present therein or has been added thereto or extracted or omitted therefrom;

(b) respecting

(i) the labelling and packaging and the offering, exposing and advertising for sale of food, drugs, cosmetics and devices, (ii) the size, dimensions, fill and other specifications of packages of food, drugs, cosmetics and devices,

(iii) the sale or the condition of sale of any food, drug, cosmetic or device, and

(iv) the use of any substance as an ingredient in any food, drug, cosmetic or device,

to prevent the consumer or purchaser thereof from being deceived or misled as to its design, construction, performance, intended use, quantity, character, value, composition, merit or safety, or to prevent injury to the health of the consumer or purchaser;

(c) prescribing standards of composition, strength, potency, purity, quality or other property of any article of food, drug, cosmetic or device;

(d) respecting the importation of foods, drugs, cosmetics and devices in order to ensure compliance with this Act and the regulations;

(e) respecting the method of preparation, manufacture, preserving, packing, storing and testing of any food, drug, cosmetic or device in the interest of, or for the prevention of injury to, the health of the consumer or purchaser;

(f) requiring persons who sell food, drugs, cosmetics or devices to maintain such books and records as the Governor in Council considers necessary for the proper enforcement and administration of this Act and the regulations;

(g) respecting the form and manner of the Minister's indication under section 12, including the fees payable therefor, and prescribing what premises or what processes or conditions of manufacture, including qualifications of technical staff, shall or shall not be deemed to be suitable for the purposes of that section;

(h) requiring manufacturers of any drugs described in Schedule E to submit test portions of any batch of such drugs and respecting the form and manner of the Minister's indication under section 13, including the fees payable therefor;

(i) not inconsistent with this Act, respecting the powers and duties of inspectors and analysts and the taking of samples and the seizure, detention, forfeiture and disposition of articles;

(j) exempting any food, drug, cosmetic or device from all or any of the provision; s of this Act and prescribing the conditions of such exemption; E/NL.1980/45-48 Page 44

(k) prescribing forms for the purposes of this Act and trie regulations;

(1) providing for the analysis of food, drugs or cosmetics other than for the purposes of this Act and prescribing a tariff of fees to be paid for such analysis;

(m) adding anything to any of the schedules, in the interest of, or for the prevention of injury to, the health of the consumer or purchaser, or deleting anything therefrom;

(n) respecting the distribution or the conditions of distribution of samples of any drug;

(o) respecting

(i) the method of preparation, manufacture, preserving, packing, labelling, storing and testing of any new drug, and

(ii) the sale or the conditions of sale of any new drug,

and defining for the purposes of this Act the expression "new drug"; and

(p) authorizing the advertising to the general public of contraceptive devices and drugs manufactured, sold or represented for use in the prevention of conception and prescribing the circumstances and conditions under which and the persons by whom such contraceptive devices and drugs may be so advertised.

Regulations respecting (2) Without limiting or restricting the authority imported drugs conferred by any other provisions of this Act or any Part thereof for carrying into effect the purposes and provisions of this Act or any Part thereof, the Governor in Council may make such regulations governing, regulating or prohibiting

(a) the importation into Canada of any drug or class of drugs manufactured outside Canada, or

(b) the distribution or sale in Canada, or the offering, exposing or having in possession for sale in Canada, of any drug or class of drugs manufactured outside Canada,

as the Governor in Council deems necessary for the protection of the public in relation to the Safety and quality of any such drug or Class of drugs.

Analysts (3) The Governor in Council may designate as an analyst any person on the staff of the Department for such time as that person is employed in the Department or for such time during the period of such employment as he may direct. E/NL.1980/45-48 Page 45

(4) The Governor in Council may designate as an Inspectors inspector any person on the staff of the Department or the Department of Consumer and Corporate Affairs for such time as that person is employed in either the Department or the Department of Consumer and Corporate Affairs or for such time during the period of such employment as he may direct. R.S., c. F-27, s. 25; 1976-77, c. 28, s. 16.

Penalties

26. Every person who violates any of the provisions of Penalties this Act or the regulations is guilty of an offence and is liable

(a) on summary conviction for a first offence to a fine hot exceeding five hundred dollars or to imprisonment for a term not exceeding three months, or to both, and for a subsequent offence to a fine not exceeding one thousand dollars or to imprisonment for a term not exceeding six months, or to both; and

(b) on conviction upon indictment to a fine not exceeding five thousand dollars or to imprisonment for a term not exceeding three years, or to both. 1952-53, c. 38, s. 25.

27. A prosecution under paragraph 26 (a) may be Time limit instituted at any time within twelve months from the time the subject-matter of the prosecution arose. 1952-53, c. 38, s. 26

28. A prosecution for a violation of this Act or the Venue regulations may be instituted, heard, tried or determined in the place in which the offence was committed or the subject-matter of the prosecution arose or in any place in which the accused is apprehended or happens to be. 195 2-53, c. 38, s. 27.

29. (1) Subject to subsection (2), in a prosecution for Want of knowledge the sale of any article in contravention of this Act or the regulations, if the accused proves to the satisfaction of the court or judge that

(a) he purchased the article from another person in packaged form and sold it in the same package and in the same condition the article was in at the time he purchased it, and

(b) that he could not with reasonable diligence have ascertained that the sale of the article would be in contravention of this Act or the regulations, the accused shall be acquitted.

(2) Subsection (1) does not apply in any Notice prosecution unless the accused, at least ten days before the day fixed for the trial, has given to the prosecutor notice in writing that he intends to avail himself of the E/NL.1980/45-48 Page 46

provisions of subsection (1) and has disclosed to the prosecutor the name and address of the person from whom he purchased the article and the date of purchase. 1952-53, c. 38, s. 28.

Evidence

Certificate of analyst 30. (1) Subject to this section, in any prosecution for an offence under section 26 or an offence mentioned in subsection 36 (1) or 44 (1), a certificate of an analyst stating that he has analyzed or examined an article, sample or substance submitted to him and stating the results of his analysis or examination is admissible in evidence and in the absence of evidence to the contrary is proof of the statements contained in the certificate without proof of the signature or official character of the person appearing to have signed the certificate.

Name of manufacturer 31. (1) Proof that a package containing any article to which this Act or the regulations apply bore a name or address purporting to be the name or address of the person by whom it was manufactured or packaged is prima facie proof, in a prosecution for a violation of this Act or the regulations, that the article was manufactured or packaged, as the case may be, by the person whose name or address appeared on the package.

Offence by employees (2) In a prosecution for a violation of this Act or the regulations it is sufficient proof of the offence to establish that it was committed by an employee or agent of the accused whether or not he is identified or has been prosecuted for the offence.

Copies of records (3) In a prosecution for a violation of this Act or the regulations a copy of a record or an extract therefrom certified to be a true copy by the inspector who made it pursuant to paragraph 22 (1) (c) is receivable in evidence and is prima facie proof of the contents thereof.

Possession of (4) Where a person is prosecuted under this Act for adulterating substances having manufactured an adulterated food or drug for sale, and it is established that

(a) the food or drug has by regulation been declared to be adulterated if any prescribed substance has been added thereto, and E/NL.1980/45-48 Page .47

(b) such person had in his possession or on his premises any such prescribed substance, the onus of proving that the food or drug was not adulterated by the addition of such substance lies on the accused. 1952-53, c. 38, s. 29; 1968-69, c. 41, s. 5.

Exports

32. This Act does not apply to any packaged food, drug Exports (other than a drug or other substance defined as a controlled drug by Part III or as a restricted drug by Part IV), cosmetic or device, not manufactured for consumption in Canada and, not sold for consumption in Canada, if the package is marked in distinct overprinting with the word "Export", and a certificate that the package and its contents do not contravene any known requirement of the law of the country to which it is or is about to be consigned, has been issued in respect thereof in prescribed form and manner. 1960-61, c. 37, s. 1; 1968-69, c. 41, s. 6.

PART III CONTROLLED DRUGS

33. In this Part Definitions

"controlled drug" means any drug or other substance "controlled drug" included in Schedule G;

"possession" means possession as defined in the "possession" Criminal Code;

"traffic" means to manufacture, sell, export from or "traffic" import into Canada, transport or deliver, otherwise than under the authority of this Part or the regulations. 1960-61, c. 37, s. 1; 1968-69, c. 41, s. 7.

34. (1) No person shall traffic in a controlled drug Trafficking in or any substance represented or held out by him to be a controlled drug controlled drug.

(2) No person shall have in his possession any Possession for controlled drug for the purpose of trafficking. trafficking

(3) Every person who violates subsection (1) or (2) Offence is guilty of an offence and is liable

(a) upon summary conviction to imprisonment for eighteen months; or

(b) upon conviction on indictment, to imprisonment for ten years. 1960-61, c. 37, s. 1.

35. (1) In any prosecution for a violation of Procedure in prosecution subsection 34 (2), if the accused does not plead for possession for guilty, the trial shall proceed as if the issue to be trafficking tried is whether the accused was in possession of a controlled drug. E/NL.1980/45-48 Page 48

Idem (2) If, pursuant to subsection (1), the court finds that the accused was not in possession of a controlled drug, he shall be acquitted, but, if the court finds that the accused was in possession of a controlled drug, he shall be given an opportunity of establishing that he was not in possession of the controlled drug for the purpose of trafficking, and thereafter the prosecutor shall be given an opportunity of adducing evidence to the contrary.

Idem (3) If the accused establishes that he was not in possession of the controlled drug for the purpose of trafficking, he shall be acquitted of the offence as charged; and if the accused fails to so establish he shall be convicted of the offence as charged and sentenced accor• dingly. 1960-61, c. 37, s. 1; 1968-69, c. 41, s. 8.

Burden of proof 36. (1) No exception, exemption, excuse or qualification prescribed by law is required to be set out or negatived, as the case may be, in an information or indictment for an offence under section 34 or under section 421, 422 or 423 of the Criminal Code in respect of an offence under sec• tion 34.

Idem (2) In any prosecution under this Part the burden of proving that an exception, exemption, excuse or quali• fication prescribed by law operates in favour of the accused is on the accused, and the prosecutor is not re• quired, except by way of rebuttal, to prove that the excep• tion, exemption, excuse or qualification does not operate in favour of the accused, whether or not it is set out in the information or indictment. 1960-61, c. 37, s. 1.

Search and seizure 37. (1) A peace officer may at any time

(a) without a warrant enter and search any place other than a dwelling-house, and under the authority of a writ of assistance or a warrant issued under this section, enter and search any dwelling-house in which he reasonably believes there is a controlled drug by means of or in respect of which an offence under this Part has been committed;

(b) search any person found in such place; and

(c) seize and take away any controlled drug found in such place and any other thing that may be evidence that an offence under this Part has been committed.

Warrant to search (2) A justice who is satisfied by information upon oath that there are reasonable grounds for believing that there is a controlled drug, by means of or in respect of which an offence under this Part has been committed, in any dwelling-house may issue a warrant under his hand autho• rizing a peace officer named therein at any time to enter the dwelling-house and search for controlled drugs.

Writ of assistance (3) A judge of the Federal Court of Canada shall, upon application by the Minister, issue a writ of assis• tance authorizing and empowering the person named therein, aided and assisted by such person as the person named therein may require, at any time, to enter any dwelling- house and search for controlled drugs. E/NL.1980/45-48 Page 49

(4) For the purpose of exercising his authority under Powers of peace officer this section, a peace officer may, with such assistance as he deems necessary, break open any door, window, lock, fastener, floor, wall, ceiling, compartment, plumbing fixture, box, container or any other thing.

(5) Where a controlled drug or other thing has been Application for seized under this Part, any person may, within two months restoration from the date of such seizure, upon prior notification having been given to the Crown in the manner prescribed by the regulations, apply to a magistrate within whose territorial jurisdiction the seizure was made, for an order of restoration under subsection (6).

(6) Subject to subsection (8), where, upon the Order of restoration hearing of an application made under subsection (5), the magistrate is satisfied

(a) that the applicant is entitled to possession of the controlled drug or other thing seized, and

(b) that the thing so seized is not or will not be required as evidence in any proceedings in respect of an offence under this Part, he shall order that the thing so seized be restored forthwith to the applicant, and where the magistrate is satisfied that the applicant is entitled to possession of the thing so seized but is not satisfied as to the matters mentioned in paragraph (b), he shall order that the thing so seized be restored to the applicant,

(c) upon the expiration of four months from the date of such seizure, if no proceedings in respect of an offence under this Part have been commenced before that time, or

(d) upon the final conclusion of any such proceedings, in any other case.

(7) Where no application has been made for the return Where no application of any controlled drug or other thing seized pursuant to made this Part within two months from the date of such seizure, or an application therefor has been made but upon the hearing thereof no order of restoration is made, the thing so seized shall be delivered to the Minister who may make such disposition thereof as he sees fit.

(8) Where a person has been convicted of an offence Forfeiture of under this Part, any controlled drug seized pursuant to controlled drug this Part, by means of or in respect of which the offence was committed, and any money so seized that was used for the purchase of that controlled drug, is forfeited to Her Majesty and shall be disposed of as the Minister directs.

(9) Subsections 22 (7) and (8) and section 23 are not Sections not applicable applicable in the case of any thing seized under this Part. 1960-61, c. 37, s. 1; 1968-69, c. 41, s. 14. E/NL.1980/45-48 Page 50

Regulations 38. (1) the Governor in Cbuncil may make regulations for 2 •carrying out the purposes and provisions of this Part, and in particular but without restricting the generality of the foregoing, may make regulations,

(a) authorizing the manufacture, sale, importation, transportation, delivery or other dealing in controlled drugs and prescribing the circumstances and conditions under which and the persons by whom controlled drugs may be manuactured, sold, imported, transported, delivered or otherwise dealt in;

(b) providing for the issue of licences for the importation, manufacture or sale of controlled drugs;

(c) prescribing the form, duration and terms and conditions of any licence described in paragraph (b) and the fees payable therefor, and providing for the cancellation and suspension of such licences.

(d) requiring persons who import, manufacture, sell, administer or deal in controlled drugs to maintain Such books and records as the Governor in Council considers necessary for the proper administration and enforcement of this Part and the regulations made under this Part and to make such returns and furnish such information relating to the said controlled drugs as the Governor in Council may require;

(e) authorizing the communication of any information obtained under this Part or the regulations to provincial professional licensing authorities; and

(f) prescribing a fine not exceeding five hundred dollars or a term of imprisonment not exceeding six months, or both, to be imposed upon summary conviction as a penalty for the violation of any regulation.

Amendment of Schedule (2) The Governor in Council may, from time to time, amend Schedule G by adding thereto or deleting therefrom any substance, the inclusion or exclusion of which, as the case may be, is deemed necessary by him in the public interest. 1960-61, c. 37, s. 1.

Sections 26, 29 and 31 39. Sections 26, 29 and 31 are not applicable in any not applicable proceedings in respect of an offence under this Part or the regulations made under this Part. 1960-61, c. 37, s. 1.

PART IV RESTRICTED DRUGS

Definitions 40. In this Part

"possession" "possession" means possession as defined in the Criminal Code;

"regulations" "regulations" means regulations made as provided for by or under section 45; E/NL.1980/45-48 Page 51

"restricted drug" means any drug or other substance "restricted drug" included; in Schedule H;

"traffic" means to manufacture, sell, export from or "traffic" -import into Canada, transport or deliver, otherwise than under the authority of this Part or the regulationsi 1968-69, c. 41, s. 10.

41. (1) Except as authorized by this Part or * the Possession of regulations, no person shall have a restricted drug restricted drug in his possession.

(2) Every person who violates subsection (1) . Offence is guilty of an offence and is, liable ; ,

(a) upon summary conviction for a first offence, to a fine of one thousand dollars or to imprisonment for six months, or to both, and for a subsequent offence, to a fine of two thousand dollars or to imprisonment; c for one year, or to both; or •. \ >•..

(b) upon conviction on indictment, to a fine of five thousand dollars or to imprisonment for three years, or to both. 1968-69, c. 41^ s. 10.

42. (1) No person shall traffic in a restricted Trafficking in drug or any substance represented or held out by him restricted drug to be a restricted drug*

(2) No person shall have in his possession any Possession for the restricted drug for the purpose of trafficking. purpose of trafficking

(3) Every.person who violates subsection (1) or (2) Offence is guilty of an offence and is liable,, ( (a) upon summary conviction, to imprisonment for eighteen months; or , t (b) upon conviction oh indictment, to imprisonment for ten years. 1968^69, c. 41, s. 10.

43. (1) In any prosecution for a violation of sub• Procedure in prosecution section 42 (2), if the accused does not plead guilty, for possession for the trial shall proceed as if the issue to be tried is trafficking whether the accused was in possession of a restricted drug contrary to subsection-41 (1);. : *

(2) If, pursuant to subsection (1), the court: finds , Idem that the accused was not in possession of a restricted v drug contrary to subsection 41 (1), he shall be acquitted, but, if the court finds that the accused was in possession of a restricted drug contrary to subsection 41 (1), he shall be given an opportunity of establishing that he was not in "possession of the restricted drug for the purpose -. of trafficking and thereafter the prosecutor shall, be k given an opportunity of adducing evidence to the contrary.

(3) If, pursuant to subsection (2), the accused Idem E/NL.1980/45-48 Page 52

(a) establishes that he was not in possession of the restricted drug for the purpose of trafficking, he shall be acquitted of the offence as charged but he shall be convicted of an offence under subsection 41 (1) and sentenced accordingly; or

(b) fails to establish that he was not in possession of the restricted drug for the purpose of trafficking, he shall be convicted of the offence as charged and sentenced accordingly. 1968-69, c. 41, s. 10.

Burden of proving 44. (1) No exception, exemption, excuse or qualification exception, etc. prescribed by law is required to be set out or negatived, as the case may be, in an information or indictment for an offence under this Part or under section 421, 422 or 423 of the Criminal Code in respect of an offence under this Part.

Idem (2) In any prosecution under this Part the burden of proving that an exception, exemption, excuse or qualification prescribed by law operates in favour of the accused is on the accused, and the prosecutor is not required, except by way of rebuttal, to prove that the exception, exemption, excuse or qualification does not operate in favour of the accused, whether or not it is set out in the information or indictment. 1968-69, c. 41, s. 10.

Application of 45. (1) The provisions of sections 37 and 38 apply in sections 37 and 38 respect of this Part.

Idem (2) For the purposes of subsection (1),

(a) there shall be substituted for the expression "controlled drug", wherever it appears in section 37 or 38, the expression "restricted drug"; and

(b) a reference in section 37 or 38

(i) to "Schedule G" shall be deemed to be a reference to Schedule H, and

(ii) to "this Part" shall be deemed to be a reference to Part IV.

Additional regulations (3) In addition to the regulations provided for by subsection (1), the Governor in Council may make regulations authorizing the possession or export of restricted drugs and prescribing the circumstances and conditions under which and the persons by whom restricted drugs may be had in possession or exported. 1968-69, c. 41, s. 10.

Sections not applicable 46. Sections 26, 29 and 31 are not applicable in any proceedings in respect of an offence under this Part or the regulations. 1968-69, c. 41, s. 10.

SCHEDULE G (Sections 33 and 38)

Amphetamine and its salts E/NL.1980/45-48 Page 53

Barbituric acid and its salts and derivat ive s

Benzphetamine and its salts

Butorphanol and its salts

Chlorphentermine and its salts

DiethyIpropion and its salts

Methamphetamine and its salts

Pentazocine and its salts

Phendimetrazine and its salts

Phenmetrazine and its salts

Phentermine and its salts

Methaqualone and its salts

Me thylphenidat e and its salts

Thiobarbituric acid and its salts and derivatives

R.S., c. F-27, Sch. G; SOR/70-393; 510; S0R/71-113, (357), 460; SI/73-47; SI 7-112; S0R/77-824; S0R/78-426; II S0R/79-756.

SCHEDULE H (Section 40)

Lysergic acid diethylamide (LSD) or any salt thereof

N,N-DiethyItryptamine (DET) or any salt thereof

N,N-Dimethyltryptamine (DMT) or any salt thereof

4-Methy1-2,5-dimethoxyamphetamine (STP(DOM)) or any salt thereof

3,4-methylenedioxyamphetamine (MDA) or any salt thereof

3-methoxy-4,5-methylenedioxyamphetamine (MMDA) or any salt thereof

N-raethyl-3-piperidyl benzilate (LBJ) or any salt thereof

2,3-dimethoxyamphetamine or any salt thereof E/NL.1980/45-48 Page 54

2.4- dime thoxyamphetamine or any salt thereof

2.5- dimethoxyamphetamine or any salt thereof

2.6- dimethoxyamphetamine or any salt thereof -

3.4- dimethoxyamphetamine or any salt thereof

3.5- dimethoxyamphetamine or any salt thereof

4,9-dihydro-7-methoxy-1-methyl-3H-pyrido (3,4-b) indole (Harmaline) and any salt thereof

4,9-dihydro-l-methyl-3H-pyrido (3,4-b) indol-7-ol (Harmalol) and any salt thereof

4-methoxyamphetamine or any salt thereof

3-[2-(Dimethylamino)ethyl]-4-hydroxyindole (Psilocin) or any salt thereof

3- [2-(D imethylamino)e thy1]-4-phosph ory1oxy indole (Psilocybin) [Psilocybine] or any salt thereof

2,4,5-Trimethoxyamphetamine or any salt, isomer, or salt of isomer, thereof

3,4-methylenedioxy-N-methylamphetamine or any salt thereof

N-(l-phenylcyclohexy1) ethylamine or any salt thereof

4- bromo-2,5-dimethoxyamphetamine or any salt thereof

1-[l-(2-thieny1) cyclohexyl] piperidine and its salts

1-phenyl-N-propylcyclohexanamine or any salt thereof

Office Consolidation E/NL.1980/48 February 1980 < FOOD AND DRUGS REGULATIONS, AMENDED* 4/ C.R.C. 87Q PART G CONTROLLED DRUGS

DIVISION 1

General

G.01.001. In this Part,

* Amended by P.C. 1978-635; P.C. 1978-1520; P.C. 1979-2831; Part J. " E/NL;t#80/45^48 n;i/i Page 55' "

: "common name" with reference to a controlled drug' means the name in English or French by which the controlled drug is commonly known; ("nom usuel")

r "controlled drug" includes a preparation; ("drogue 'contrSlSe") '"' ''

"hospital" means

; (a) a hospital which is listed or referred to "in art' agreement with a province made pursuant to the Hospital Insurance and Diagnostic Services Act,

[...] •'• • ••• -•>"• ' -• •

(f) any other "institution that ' ' -

(i) Is operated primarily for the bare or treatment of persons suffering :! from any form of disease or illness, and '

'(ii) is approved by the Minister as a hospital' for the purpose of this Part; ("hSpital") , >

"licence" means a licence issued under section 6.02.003; ("licence'^

"licensed dealer" means the holder of a licence; ("distributeur autoris£") '

"parenteral use" with reference to a controlled drug means administration by' means of a hypodermic syringe, needle or other instrument through or into the skin or' mucous membrane; ("usage parenteral") ~ ;

; "permit" means a permit issued under section G.02.008; ("permis")

J "pharmacist"

(a) means a person who is registered and entitled under the laws of a province

(i) to practise pharmacy, and

(ii) to operate a pharmacy or dispensary

and who is operating a pharmacy or dispensary and is practising pharmacy thereunder in that province, and

(b) includes, for the purposes of section G.01.003, subsection G.02.025 (5) and sections G.03.002 to G.03.008 and section G.03.017 a person who is registered and entitled under the laws of a province, to practise pharmacy and who is practising pharmacy in that province; ("pharmacien")

"practitioner" means a person who is registered and entitled under the laws of a province to practise the profession of medicine, dentistry or veterinary medicine; ("practicien")

"preparation" means a drug that contains a controlled drug and one or more active medicinal ingredients, in a recognized therapeutic dose, other than a controlled drug; ("preparation")

"prescription" means a direction given by a practitioner that a stated amount of a specified controlled drug be dispensed for the person named therein; ("ordonnance")

"proper name" with reference to a controlled drug means the name in English or French E/NL. 1980745-48 Page 56

(a) assigned to the drug in section C.01.002,

(b) that appears in bold face type for the drug in the Regulations and where the drug is dispensed in a form other than that described in Part C, the name of the dispensing form, or

(c) assigned in any of the publications mentioned in Schedule B to the Act in the case of a drug not included in paragraph (a) or (b) of this definition; ("nom propre")

"test kit" means an apparatus

(a) that contains reagent systems or buffering agents or both,

(b) that is used in the course of a chemical or analytical procedure for medical, laboratory, industrial, educational or research purposes; and

•(c) the contents of which are not intended for administration to humans; ("necessaire d'essai")

"verbal order" means an order verbally given for a stated amount of a specified controlled drug by a person to whom a pharmacist is authorized by this Part to sell a controlled drug pursuant to a verbal or written order; ("commande verbale")

"written order" means an order, in writing, dated and signed by a person to whom a licensed dealer or a pharmacist is authorized by this Part to sell a controlled drug pursuant to a written order, ("commande e'crite"). S0R/78-220, s. 1.

G.01.002. Except as otherwise provided in this Part, a controlled drug shall carry

(a) on the main panel of both the inner and outer labels thereof

(i) on the upper left quarter thereof, the symbolin a clear and conspicuous colour and size,

(ii) if the drug has a proper name, the proper name of the drug which shall, where the drug has a proprietary or brand name, immediately precede or follow the proprietary or brand name in letters not less than one half the size of the letters in the proprietary or brand name,

(iii) if the drug has a proper name, the standard under which the drug was manufactured which shall

(A) where the standard is contained in any publication mentioned in Schedule B to the Act, be stated in full or by the abbreviation provided therein, or

(B) where the standard is provided by Division 5 or Division 6 of Part C of these Regulations be designated Canadian Standard Drug or C.S.D., and

(iv) if the drug does not have a proper name, the common name of the drug;

(b) on both the inner and the outer labels thereof

(i) the name of the manufacturer and, if the controlled drug is manufactured or produced outside Canada, the name of the distributor in Canada, E/NL.1980/45-48 Page 57

(ii) the address of the manufacturer or distributor except that where the immediate container contains 5 millilitres or less the statement need not be made on the inner label,

(iii) the lot number thereof,

(iv) adequate directions for use,

(v) a quantitative list of the medicinal ingredients contained therein by their proper names, or if they do not have proper names, their common names,

(vi) a correct statement of net contents in terms of weight, measure or number; and

(c) in the case of a drug intended for parenteral use, on the outer label thereof, the name and proportion of any preservative present.

G.01.002.1. Section G.01.002 does not apply to a test kit that contains a controlled drug where a registration number has been issued for the test kit pursuant to section G.06.002.3 and has not been cancelled pursuant to section G.06.002.4.

G.01.003. In the case of a controlled drug that is dispensed by a pharmacist pursuant to a prescription, section G.01.002 does not apply but the label of the package in which the controlled drug is contained shall carry the following:

(a) the name and address of the pharmacy or pharmacist;

(b) the date and number of the prescription;

(d) the name of the practitioner;

(e) directions for use; and

(f) any other information that the prescription requires be shown on the label.

G.01.004. All information required by this Part to be carried on a label shall be

(a) clearly and prominently displayed thereon; and

(b) readily discernible to the purchaser or consumer under the customary conditions of purchase and use.

G.01.005. Where a package of a controlled drug has only one label, that label shall contain all the information required by this Part to be shown on both the inner and the outer label.

G.01.006. Except as otherwise provided in this Part, no person shall sell a controlled drug or preparation that does not comply with all provisions of Parts C and D applicable to it.

G.01.007. No person shall

(a) advertise a controlled drug to the general public; or

(b) issue or publish any other written advertisement respecting a controlled drug unless that advertisement carries the symbol <^ in a clear and conspicuous colour and size in the upper left quarter of the first page of the advertisement. E/NL.1980/45-48 Page 58

G.01.008. Where it is necessary to provide adequate directions for use for the safe use of a Schedule G drug that is used in the treatment or prevention of any disease, disorder or abnormal physical state mentioned in Schedule A to the Act, that disease, disorder or abnormal physical state may be mentioned on the labels and inserts accompanying that drug and, to such extent, that drug is hereby exempted from the provisions of section 3 of the Act.

Prescribed Manner of Notice of Application for an Order of Restoration

G.01.010. (1) For the purpose of subsection 37 (5) of the Act, notice of application for an order of restoration shall be given to the Crown in writing by registered mail addressed to the Minister of National Health and Welfare at Ottawa.

(2) The notice referred to in subsection (1) shall be mailed not less than 15 clear days prior to the date the application for an order of restoration is to be made to the magistrate and shall specify

(a) the magistrate to whom the application is to be made;

(b) the time and place where the application is to be heard;

(d) the evidence upon which the applicant intends to rely to establish that he is entitled to possession of the controlled drug or other thing referred to in paragraph (c).

DIVISION 2

Licences and Licensed Dealers

G.02.001. Subject to this Part, no person except a licensed dealer shall manufacture, import, export or sell a controlled drug.

G.02.002. No licensed dealer may import or export a controlled drug without a permit.

G.02.003. The Minister may, upon application therefor, issue a licence to any person who, in the opinion of the Minister, is qualified to be a licensed dealer, for the manufacture or sale of a controlled drug.

G.02.004. An applicant for a licence shall specify in the application the controlled drugs in respect of which the licence is to apply.

G.02.005. A licensed dealer may manufacture or sell only the controlled drugs specified in his licence.

G.02.006. A licensed dealer may at any time make application to the Minister to amend the licence in order to include controlled drugs other than those specified in his licence.

G.02.007. An application for a licence shall be made in a form approved by the Minister and shall, except in the case of an application for or on behalf of

(a) any branch or agency of the Government of Canada, of the government of a province or any employee thereof, or

(b) any person or organization engaged in scientific investigations, be accompanied by a fee of $25. SOR/78-220, s. 2. E/NL.1980/45-48 Page 59

G.02.008. The Minister may, upon application therefor, issue a permit to any licensed dealer for the importation or exportation of a controlled drug.

G.02.009. An application for a permit shall be in a form approved by the Minister.

G.02.010. Every licence or permit issued under this Part is subject to the condition that the licensed dealer will comply with the provisions of this Part.

G.02.011. The Minister may revoke or suspend a licence or permit issued under this Part if, in his opinion, the person to whom it was issued has violated or failed to comply with any term or condition thereof or any provision of this Part.

G.02.012. A licence issued under section G.02.003 expires on the December 31 next following the day on which it is issued.

G.02.013. A permit issued under section G.02.008 is valid only for the particular importation or exportation in respect of which it was issued. ... ; G.02.014. (1) Every licensed dealer shall keep a record of the following;

(a) the name and quantity of any controlled drug received by him, the name and address of the person wbo supplied, it, and the date it was received;

(b) the name, quantity and form of any controlled drug supplied by him, the name and address of the person to whom it was supplied and the date it was supplied;

(c) the name and quantity of any controlled drug used in manufacturing, the name and quantity of any controlled drug manufactured, and the date any manufactured controlled drug was placed in stock; and

(d) the name and quantity of any controlled drug he had in stock at the end of each month.

(2) The record of information referred to in subsection (1) shall be kept

(a) in a manner that permits an audit to be made;

(b) subject to subsection (3), in a book, register or similar record maintained exclusively for controlled drugs; and

(3) The record of information referred to in paragraphs (1) (a), (b) and (d) may, with respect to a controlled drug listed in the schedule to this Part, be kept in a form other than that specified in paragraph (2) (b). SOR/78-427, s. 1.

G.02.015. The Minister may, in respect of a licensed dealer, require an inspection to be made at any reasonable time of the following:

(a) the premises used or intended to be used by the licensed dealer in manufacturing or storing a controlled drug;

(b) the process and conditions of the manufacturing or storing;

(d) the record of information referred to in section G.02.014. SOR/78-427, s. 2. E/NL.1980/45-48 Page 60

G.02.016. Every licensed dealer shall

(a) furnish such information respecting the dealings of such person in any controlled drug in such form and at such times as the Minister may require;

(b) produce to an inspector any books, records or documents required to be kept by this Part;

(d) permit an inspector to check all stock of controlled drugs located on the premises described in the licence of the licensed dealer.

G.02.017. [Revoked, S0R/78-427, s. 3],

G.02.018. Every licensed dealer shall notify the Minister promptly of changes in the following;

(a) his technical staff;

(b) the premises in which a controlled drug is manufactured or stored; and

G.02.019. Every licensed dealer shall

(a) provide such protection against loss or theft of any controlled drug in his possession as may be required by the Minister;

(b) report to the Minister any loss or theft of a controlled drug within 10 days of his discovery thereof; and

(c) securely pack a controlled drug in its immediate container and seal it in such a manner that it cannot be opened without breaking the seal.

G.02.020. A licensed dealer may only import into or export out of Canada a controlled drug at the place specified in his permit.

G.02.021. A licensed dealer shall securely pack in a package sealed in such a manner that it cannot be opened without breaking the seal any controlled drug intended for export out of Canada.

G.02.022. A licensed dealer shall in taking delivery of a controlled drug imported by him or in making delivery of a controlled drug

(a) take such steps as are necessary to ensure the safekeeping of the drug during transit; and

(b) use such method of transportation as will ensure an accurate record being kept of the drug and of the signatures of any persons having charge of the drug until it is delivered to the consignee.

G.02.023. Notwithstanding section G.02.022, a preparation may be delivered by common carrier.

G.02.024. A licensed dealer shall not supply a controlled drug to any person or institution other than a E/NL.1980/45-48 Page 61

(a) licensed dealer;

(b) pharmacist;

(d) hospital;

(e) Regional Director of the Health Protection Branch; or

(f) person authorized by the Minister to acquire a controlled drug. SOR/78-220, s. 3.

G.02.024.1. Subject to section G.02.024.2 and notwithstanding sections G.02.024 and G.02.025, no licensed dealer shall

(a) supply a controlled drug, other than a preparation, to a pharmacist identified in a notice given by the Minister pursuant to section G.03.017.1;

(b) supply a preparation to a pharmacist identified in a notice given by the Minister pursuant to section G.03.017.2;

(c) supply a controlled drug other than a preparation to a practitioner identified in a notice given by the Minister pursuant to section G.04.004.1; or

(d) supply a preparation to a practitioner identified in a notice given by the Minister pursuant to section G.04.004.2.

G.02.024.2. Section G.02.024.1 does not apply to a licensed dealer to whom the Minister has given notice of revocation

(a) pursuant to section G.03.017.4 in respect of a pharmacist identified in a notice given by the Minister pursuant to section G.03.017.1 or G.03.017.2; or

(b) pursuant to section G.04.004.4 in respect of a practitioner identified in a notice given by the Minister pursuant to section G.04.004.1 or G.04.004.2.

G.02.025. (1) Subject to this section, a licensed dealer may, in accordance with the terms and conditions of his licence, supply a controlled drug to a person or an institution referred to in section G.02.024 if

(a) the drug is in a package authorized and described in the licence of the manufacturer; and

(b) the licensed dealer has received, on the premises described in the licence,

(i) a written order,

(ii) an order sent through a computer from a remote input device, or

(iii) an oral order for a controlled drug listed in the schedule to this Part or for a preparation that specifies the name and the quantity of the drug to be supplied.

(2) Where a licensed dealer has received a written order referred to in subparagraph (1) (b) (i), he may supply a controlled drug to a person or an institution referred to in section G.02.024 if

(a) the order is signed E/NL.1980/45-48 Page 62

(i) by the person to whom the drug is to be supplied, or

(ii) in the case of an order made on behalf of a hospital, by the pharmacist in charge of the dispensary of the hospital or by a practitioner authorized by the hospital to sign the order on its behalf; and

(b) the signature referred to in paragraph (a), if unknown to the licensed dealer, is verified.

(3) A licensed dealer may supply a controlled drug pursuant to an order received from a remote input device through a computer if the computer program and the remote input device meet the requirements thereof set out in subsections (5) and (6).

(4) Where a licensed dealer has received an oral order referred to in subparagraph (1) (b) (iii), he may supply a preparation to a person or institution referred to in paragraphs G.02.024 (b) to (d) if he forthwith records

(a) the name of the person to whom the preparation is to be supplied;

(5) For the purposes of this section, a remote input device shall be a device for transmitting electronically orders for drugs, other than by voice communication, that

(a) contains a unique identifying code that can be related to the device and the pharmacist or practitioner in whose possession and care the remote input device has been placed;

(b) is in the possession and care of that pharmacist or practitioner; and

(c) is designed in such a way that the unique identifying code for the remote input device is an integral part of the circuitry and can only be modified by the dismantling of the device.

(6) For the purposes of this section, a computer program shall be able to

(a) identify the remote input device, the name and address of the pharmacist or practitioner in whose possession and care the remote input device has been placed;

(b) identify the pharmacist or practitioner placing the order by means of an identifying code unique to that pharmacist or practitioner;

(d) detect unusual orders and thereby necessitate manual intervention by the licensed dealer; and

(e) necessitate manual intervention by the licensed dealer if one or more of the check procedures fails.

(7) Where a licensed dealer has received an oral order or an order sent from a remote input device through a computer from a pharmacist or practitioner, he shall within 5 working days of filling the order for a controlled drug, obtain and keep a receipt that includes E/NL.1980/45-48 Page 63

(a) the signature of the pharmacist or the practitioner who received the controlled drug;

(b) the date the pharmacist or practitioner received the controlled drug; and

(8) Where a licensed dealer does hot receive, within the' time stipulated in subsection (7), a receipt as required from the pharmacist or practitioner who placed the order, he shall not, until such time as he receives the receipt, supply any controlled drug pursuant to any further oral order or order sent from av remote •'input.'device from such pharmacist or practitioner. SOR/78-220, s. 4; SOR/78-427, s. 4.

G.02.026. A licensed dealer shall not supply a controlled drug more than once in respect of one order unless

(a) the order for the drug states that the quantity of the drug is to be supplied

1 (i) in specified portions,

(ii) in separate deliveries not exceeding four deliveries, and

(iii) at specified intervals; or

(b) the licensed dealer is temporarily out of stock at the time of receipt of the order of the type and quantity of the drug ordered in which case he may supply against the order the quantity of the drug that he has available and deliver the balance thereafter in accordance with the order.

G.02.027. No licensed dealer shall supply a controlled drug that is not labelled as required by section G.01.002.

DIVISION 3

Pharmacists

G.03.001. (1) A pharmacist, on receipt of a controlled drug from a licensed dealer or from another pharmacist, shall keep or cause to be kept a record of the name and quantity of the controlled drug received by him, the name and address of the person who supplied it and the date on which it was received.

(2) The record of information referred to in subsection (1) shall be kept

(a) in a manner that permits an audit to be made; and

(b) subject to subsection (3), in a book, register or similar record maintained exclusively for controlled drugs.

(3) The record of information referred to in subsection (1) may, with respect to a controlled drug listed in the schedule to this Part, be kept in a form other than that specified in paragraph (2) (b). SOR/78-427, s. 5.

G.03.002. No pharmacist shall, except as otherwise provided in this Part, dispense a controlled drug to any person unless he has first been furnished with a prescription therefor, and

(a) if the prescription is in writing, it has been signed and dated by the practitioner issuing the same and the signature of the practitioner where not known to the pharmacist, has been verified by him; or E/NL.1980/45-48 Page 64

(b) if the prescription is given verbally, the pharmacist has taken reasonable precaution to satisfy himself that the person giving the prescription is a practitioner.

G.03.002.1. Subject to section 6.03.002.2 and notwithstanding sections G.03.002, G.03.003 and G.03.005, no pharmacist shall

(a) supply a controlled drug, other than a preparation, to a pharmacist identified in a notice given by the Minister pursuant to section G.03.017.1;

(b) supply a preparation to a pharmacist identified in a notice given by the Minister pursuant to section G.03.017.2;

(c) dispense or supply a controlled drug, other than a preparation, to, or pursuant to a prescription or order given by, a practitioner identified in a notice given by the Minister pursuant to section G.04.004.1; or

(d) dispense or supply a preparation to a practitioner or pursuant to a prescription or order given by a practitioner identified in a notice given by the Minister pursuant to section G.04.004.2.

G.03.002.2. Section G.03.002.1 does not apply to a pharmacist to whom the Minister has given notice of revocation

(a) pursuant to section G.03.017.4 in respect of a pharmacist identified in a notice given by the Minister pursuant to section G.03.017.1 or G.03.017.2; or

(b) pursuant to section G.04.004.4 in respect of a practitioner identified in a notice given by the Minister pursuant to section G.04.004.1 or G.04.004.2.

G.03.003. A pharmacist may supply a controlled drug to a practitioner for use in his practice

(a) upon a written order which has been verified if the signature of the practitioner is unknown to the pharmacist; or

(b) upon a verbal order after the pharmacist has taken reasonable precautions to satisfy himself that the person making the order is a practitioner.

G.03.004. A pharmacist shall, in respect of controlled drugs supplied to a practitioner under section G.03.003, keep in the special prescription file a record showing the date, the name and address of the practitioner, and the quantity and kind of controlled drug so furnished.

G.03.005. A pharmacist may supply a controlled drug to a hospital upon a written order from .;•

(a) the pharmacist in charge of the dispensary of the hospital, or

(b) a practitioner authorized by the hospital to sign the order on its behalf,

if the signature of the pharmacist or practitioner is known or has been verified.

G.03.006. A pharmacist shall not refill a prescription for a controlled drug unless

(a) the practitioner, at the time that he issued the prescription, directed

(i) in writing or orally, in the case of a controlled drug listed in the schedule to this Part, or E/NL.1980/45-48 Page 65

(ii) in writing, in the case of a controlled drug not listed in the schedule to this Part,

that the prescription be refilled, the number of times that it may be refilled and the dates for or intervals between refills; and

(b) the pharmacist keeps a record of each refilling of a prescription. S0R/78-42 7, s. 6.

G.03.007. A pharmacist who dispenses, pursuant to an order or prescription, a controlled drug other than a preparation or a controlled drug listed in the schedule to this Part shall forthwith enter in a book, register or similar record maintained for such purposes

(a) the name and address of the person named in the order or prescription;

(b) the name, initials and address of the practitioner who issued the order or prescription;

(d) the name, quantity and form of the controlled drug dispensed;

(e) the date on which the controlled drug was supplied; and

(f) the number assigned to the order or prescription. S0R/78-427, s. 7.

G.03.008. A pharmacist shall, before dispensing a controlled drug pursuant to a prescription or order verbally given, make a written record thereof, setting forth,

(a) the name and address of the,person named in the prescription;

(b) the name, quantity and form of such controlled drug;

(d) the name, initials and address of the practitioner who issued the prescription;

(e) the name or initials of the pharmacist who dispensed such controlled drug;

(f) the date such controlled drug was supplied; and

(g) the number assigned to the prescription.

G.03.009. A pharmacist shall maintain a special prescription file in which shall be filed in sequence as to date and number all written orders or prescriptions in writing for controlled drugs dispensed and the written record of all controlled drugs dispensed pursuant to a prescription or order verbally given.

G.03.010. A pharmacist shall retain in his possession for a period of at least two years, any records which he is required to keep by this Part.

G.03.011. A pharmacist shall

(a) furnish such information respecting the dealings of the pharmacist in any controlled drug in such form and at such times as the Minister may require; E/NL.1980/45-48 Page 66

(b) make available and produce to an inspector upon request his special prescription file together with any books, records or documents which he is required to keep;

(d) permit an inspector to check all stocks of controlled drugs on his premises.

G.03.012. A pharmacist shall take all necessary steps to protect controlled drugs on his premises or under his control against loss or theft.

G.03.013 A pharmacist shall report to the Minister any loss or theft of a controlled drug within 10 days of his discovery thereof.

G.03.014. A pharmacist may

(a) upon receiving a written order from a licensed dealer who supplied a controlled drug to him return the drug to the dealer;

(b) upon receiving a written order from a pharmacist, supply to the pharmacist such quantities of a controlled drug as are specified in the order for emergency needs or purposes; or

(c) upon receiving a written order from a Regional Director of the Food and Drug Directorate a/ supply to or to the order of that Regional Director such quantities of a controlled drug as are required by him in connection with his duties and specified in such order.

G.03.015. A pharmacist shall forthwith after supplying a controlled drug under section G.03.014 enter the details of the transaction in a book, record or other register maintained for the purpose of recording such transactions.

G.03.016. A pharmacist shall forthwith after removing, transporting or transferring a controlled drug from his place of business to any other place of business operated by him notify the Minister, setting out the details.

G.03.017. The Minister may, in any of the circumstances described in paragraphs G.03.017.3 (a) to (e), communicate to the appropriate provincial authority of the province in which a pharmacist is registered and entitled to practise pharmacy information with respect to the pharmacist obtained under these Regulations together with any other information he considers relevant.

G.03.017.1. The Minister

(a) shall, in the circumstance described in subparagraph G.03.017.3 (a) (i), and

(b) may, in the circumstance described in subparagraph G.03.017.3 (b) (i) or paragraph G.03.017.3 (c) or (d), after consultation with the licensing authority of the province in which the pharmacist is registered and entitled to practise pharmacy,

a/ Note: Now Health Protection Branch. E/NL.1980/45-48 Page 67. give notice to licensed dealers and pharmacists of the name and address of the pharmacist to whom the circumstance is applicable.

G.03.017.2. The Minister

(a) shall, in the circumstance described in subparagraph G.03.017.3 (a) (ii), and

(b) may, in the circumstance described in subparagraph G.03.017.3 (b) (ii) or paragraph G.03.017.3 (c) or (e) after consultation with the licensing authority of the province in which the pharmacist is registered and entitled to practise pharmacy, give notice to licensed dealers and pharmacists of the name and address of the pharmacist to whom the circumstance is applicable.

G.03.017.3. For the purposes of sections G.03.017 to G.03.017.2, the circumstances described in this section are as follows:

(a) a pharmacist has made a written request to the Minister that a notice be given by the Minister to licensed dealers and pharmacists setting out the pharmacist's name and address and stating that

(i) no controlled drug, other than a preparation, should be supplied to him, or

(ii) no preparation should be supplied to him;

(b) a pharmacist has violated a rule of conduct of the appropriate licensing authority of the province in which he is registered and entitled to practise pharmacy and that the authority has made a written request to the Minister that a notice be given by the Minister identifying him pursuant to

(i) section G.03.017.1, or

(ii) section G.03.017.2;

(d) a pharmacist is unable to demonstrate that all controlled drugs, other than preparations purchased or obtained by him, have been furnished by him in accordance with these Regulations; and

(e) a pharmacist is unable to demonstrate that all preparations purchased or obtained by him have been furnished by him in accordance with these Regulations.

G.03.017.4. Where the Minister has given notice pursuant to section G.03.017.1 or G.03.017.2 of the name and address of a pharmacist and the circumstances described in section G.03.017.5 have occurred, the Minister shall give notice of revocation of that notice in respect of that pharmacist to licensed dealers and pharmacists.

G.03.017.5. For the purposes of section G.03.017.4, the circumstances described in this section are as follows:

(a) a pharmacist and the appropriate licensing authority of the province in which the pharmacist is registered and entitled to practise pharmacy have made a written request to the Minister that the Minister revoke the notice given by the Minister identifying the pharmacist pursuant to E/NL.1980/45-48 Page 68

(i) section G.03.017.1, or

(ii) section G.03.017.2; and

(b) one year has elapsed since the notice referred to in paragraph (a) was given by the Minister.

DIVISION 4

Practitioners

G.04.001. (1) In this section,

"administer" includes prescribe, give, sell, furnish, distribute or deliver;

"designated drug" means any of the following controlled drugs:

(a) amphetamine and its salts,

(b) benzphetamine and its salts,

(d) phenmetrazine and its salts, or

(e) phendimetrazine and its salts.

(2) Subject to subsections (3) and (4) and section G.06.001, no practitioner shall administer a controlled drug to any person or animal.

(3) A practitioner may administer a controlled drug, other than a designated drug, to a person or to an animal, if

(a) that person or animal is a patient under his professional treatment; and

(b) the controlled drug is required for the condition for which the patient is receiving treatment.

(4) A practitioner may administer a designated drug to an animal or a person who is a patient under his professional treatment where the designated drug is for the treatment of any of the following conditions:

(a) in humans

(i) narcolepsy,

(ii) hyperkinetic disorders in children,

(iii) mental retardation (minimal brain dysfunction),

(iv) epilepsy,

(v) parkinsonism, or

(vi) hypotensive states associated with anesthesia; or

(b) in animals, depression of cardiac and respiratory centres. E/NL.1980/45-48 Page 69

G.04.002. (1) A practitioner who furnishes a controlled drug to a person for self-administration or for administration to an animal shall, whether or not he makes a charge therefor, if he furnishes the controlled drug in an amount

(a) that exceeds three times the maximum daily dosage recommended by the manufacturer of that controlled drug for that controlled drug; or

(b) if the manufacturer has not recommended a maximum daily dosage, that exceeds three times the generally recognized maximum daily therapeutic dosage for that controlled drug; keep a record showing

(d) the name and address: of the person to whom it was furnished; and

(e) the date on which it was furnished.

(2) A practitioner who is required by this section to keep a record shall keep the record in a place, form and manner that will permit an inspector readily to examine and obtain information from it.

G.04.002A. A practitioner shall

(a) furnish to the Minister on request such information respecting

(i) the receipt and use by the practitioner of controlled drugs (including the administering and furnishing thereof to a person), and

(ii) the prescriptions for controlled drugs issued by the practitioner,

as the Minister may require;

(b) produce to an inspector on request any records that these Regulations require the practitioner to keep;

(d) permit an inspector to check all stocks of controlled drugs on the practitioner's premises;

(e) retain in his possession for at least two years any record that these Regulations require him to keep;

(f) take adequate steps to protect controlled drugs in his possession from loss or theft; and

(g) report to the Minister any loss or theft of a controlled drug within 10 days of the practitioner's discovery of the loss or theft.

G.04.003. Where a practitioner alleges or, in any prosecution for an offence under the Act or this Part, pleads that his possession of a controlled drug was for use in his practice or that he prescribed, administered, gave, sold or furnished a controlled drug to any person or animal as a patient under his professional treatment and that such controlled drug was required for the condition for which the patient received treatment, the burden of proof thereof shall be on such practitioner. E/NL.1980/45-48 Page 70

G.04.004. The Minister may, in any of the circumstances described iir paragraphs G.04.004.3 (a) to (i), communicate to the appropriate licensing authority of the province in which a practitioner is registered and entitled to practise information with respect to the practitioner obtained under these Regulations together with any other information he considers' relevant.

G.04.004.1. The Minister

(a) shall-, in the circumstances described in subparagraph G.04.004.3 (a).(i), and

(b) may, in the circumstances described in subparagraph G.04.004.3 (b) (i) or paragraph G.04.004.3 (c), (d), (e) or (f), after consultation with the licensing authority of the province in which the practitioner is registered and entitled to practise, give notice to licensed dealers and pharmacists of the name and address of the practitioner to whom the circumstance is applicable.

G.04.004.2. The Minister

(a) shall, in the circumstances described in subparagraph G.04.004.3 (a) (ii), and

(b) may, in the circumstances described in subparagraph G.04.004.3 (b) (ii), or paragraph G.04.004.3 (c), (g), (h) or (i), after consultation with.the licensing authority of the province in which the practitioner is registered and entitled to practise, give notice to licensed dealers and pharmacists of the name and address of the practitioner to whom the circumstance is applicable.

G.04.004.3. For the purposes of sections G.04.004 to G*04.004.2, the circumstances described in this section are as follows:

(i) no controlled drug, other than a preparation, should,be supplied to him, or

(ii) no preparation should be supplied to him;

(i) section G.04.004.1, or

(ii) section G.04.004.2;

(d) a practitioner has repeatedly administered a controlled drug other than a preparation to himself on his own prescription or order other than in accordance with normal or accepted medical or dental practice; E/NL.1980/45-48 Page 71

(e) a practitioner has repeatedly prescribed, furnished or administered a controlled drug, other than a preparation, to his spouse, parent or child for other than normal or accepted medical or dental use;

(f) a practitioner is unable to demonstrate that all controlled drugs, other than preparations purchased or obtained by him have been used or otherwise dealt with by him in accordance with these Regulations after the Minister has made a request pursuant to section G.04.002A;

(g) a practitioner has repeatedly administered a preparation to himself on his own prescription or order other than in accordance with normal or accepted medical or dental practice;

(h) a practitioner has repeatedly prescribed, furnished or administered a preparation to his spouse, parent or child for other than normal or accepted medical or dental use; and

(i) a practitioner is unable to demonstrate that all preparations purchased or obtained by him have been used or otherwise dealt with by him in accordance with these Regulations after the Minister has made a request pursuant to section G.04.002A.

G.04.004.4. Where the Minister has given notice pursuant to section G.04.004.1 or G.04.004.2 of the name and address of a practitioner and the circumstances described in section G.04.004.5 have occurred, the Minister shall give notice of revocation of that notice in respect of that practitioner to licensed dealers and pharmacists.

G.04.004.5. For the purposes of section G.04.004.4, the circumstances described in this section are as follows:

(b) one year has elapsed since the notice referred to in paragraph (a) was given by the Minister.

DIVISION 5

Hospitals

G.05.001. A person who is in charge of a hospital shall keep or cause to be kept a record of the following information:

(a) the name and quantity of any controlled drug received by the hospital;

(b) the name and address of the person from whom any controlled drug was received and the date on which it was received;

(c) the name and quantity of any controlled drug used in manufacturing, the name and quantity of any controlled drug manufactured and the date of manufacture thereof;

(d) the name of the patient for whom a controlled drug was dispensed;

(e) the name of the practitioner ordering or prescribing a controlled drug; and E/NL.1980/45-48 Page 72

(f) the date on which a controlled drug was ordered or prescribed and the form and quantity thereof.

(2) Subject to subsections (3) and (4), the record of information referred to in subsection (1) shall be kept

(a) in a manner that permits an audit to be made;

(b) in a book, register or similar record maintained exclusively for controlled drugs; and

(3) The information referred to in paragraphs (1) (d) to (f) may, with respect to a preparation, be kept in a manner or form other than specified in subsection (2).

(4) The information referred to in subsection (1) may, with respect to a controlled drug listed in the schedule to this Part, be kept in a form other than that specified in paragraph (2) (b). SOR/78-427, s. 8.

G.05.002. A person who is in charge of a hospital shall

(a) furnish such information respecting the use of controlled drugs therein, in such form and at such times as the Minister may require;

(b) produce to an inspector any books, records or documents required by these Regulations to be kept;

(d) permit an inspector to check all stocks of controlled drugs in the hospital.

G.05.003. A person in charge of a hospital shall permit a controlled drug to be dispensed or administered only

(a) to a person or animal under treatment as an in-patient or out-patient; and

(b) upon a prescription or the authorization of a practitioner.

G.05.004. A person who is in charge of a hospital shall take all steps necessary to protect controlled drugs in the hospital against loss or theft and shall report to the Minister any loss or theft of a controlled drug within 10 days of his discovery thereof. SOR/78-427, s. 9.

DIVISION 6

Authority and Penalty

G.06.001. (1) Where the Minister deems it to be in the public interest or the interest of science, he may, for the purposes, and subject to the conditions, set out in the authorization, authorize in writing

(a) any person to administer a controlled drug to an animal;

(b) any practitioner of medicine to prescribe, administer, give, sell, furnish, distribute, or deliver a controlled drug to any person; E/NL.1980/45-48 Page 73

(d) any person to receive a controlled drug from a practitioner of medicine.

(2) The Minister may, at any time, revoke the authorization referred to in subsection (1) and the person whose authorization is so revoked shall retain possession of the controlled drug or deliver it to the Minister or his agent.

(3) Notwithstanding anything in these Regulations, a person may, for the purpose of identification or analysis thereof, give or deliver a controlled drug that he has in his possession to

(a) a practitioner of medicine; or

(b) an agent of a practitioner of medicine, which agent has been authorized by the Minister pursuant to subsection (1) to receive that controlled drug.

(4) Where an agent of a practitioner of medicine has received a controlled drug pursuant to subsection (3) he shall forthwith give or deliver it

(a) to the practitioner of whom he is the agent; or

(b) to the Minister or his agent.

(5) A practitioner of medicine who has received a controlled drug pursuant to subsection (3) or (4) shall forthwith give or deliver it

(a) for the purpose of identification or analysis thereof, to a person authorized by the Minister pursuant to subsection (1) to receive it for that purpose; or

(b) to the Minister or his agent.

6.06.002. Every person who is, pursuant to subsection G.06.001 (1), authorized to administer or receive a controlled drug shall

(a) keep a record of

(i) the kind, date and quantity of any controlled drug purchased or received by him,

(ii) the name and address of the person from whom the controlled drug was received, and

(iii) particulars of the use to which the controlled drug was put; and

(b) furnish such information respecting such controlled drugs as the Minister may require, and shall permit access to the records required to be kept by the Part.

Test Kits Containing Controlled Drugs

G.06.002.1. Any person may sell, possess or otherwise deal in a test kit that contains a controlled drug if

(a) a registration number has been issued for the test kit pursuant to section G.06.002.3; E/NL.1980/45-48 Page 74

(b) the test kit bears, on its external surface,

(i) the manufacturer's name,

(ii) the trade name or trade mark, and

(iii) the registration number issued therefor pursuant to section G.06.002.3;

(c) the test kit is sold, possessed or otherwise dealt in for the purpose of medical, laboratory, industrial, educational or research use; and

(d) the registration number has not been cancelled pursuant to section G.06.002.4.

G.06.002.2. The manufacturer of a test kit that contains a controlled drug may apply for a registration number therefor by submitting to the Director an application containing

(a) particulars of the design and construction of the test kit;

(b) a detailed description of the controlled drug and other substances, if any, contained in the test kit, including the qualitative and quantitative composition of each component;

(d) any further information and material that the Minister may require in order to satisfy himself that the test kit is one for which a registration number may be issued.

G.06.002.3. Where, on application under section G.06.002.2, the Minister is satisfied that the test kit to which the application applies will only be used for medical, laboratory, industrial, educational or research use and that it

(a) contains a controlled drug and one or more adulterating or denaturing agents in such a manner, combination, quantity, proportion or concentration that the preparation or mixture has no significant drug abuse potential, or

(b) contains such small quantities or concentrations of any controlled drug as to have no significant drug abuse potential and is a test kit identified in the table to this section, the Minister may issue a registration number for the test kit, which shall be a number preceded by the letters "TK".

TABLE

Column I Column II Column III

Names of Manufacturer Names of Test Kit Form of Product E/NL.1980/45-48 Page 75

G.06.002.4. The Minister may cancel the registration number for a test kit if the test kit is removed from the market by the manufacturer or if, in the Minister's opinion,

(a) it is necessary to cancel the registration number in the interest of public health; or

(b) the test kit is used or is likely to be used for any purpose other than medical, laboratory, industrial, educational or research use.

G.06.003, Any person who violates any provision of this Part is guilty of an offence and is liable on summary conviction to a fine not exceeding $500 or to a term of imprisonment not exceeding six months, or to both such fine and imprisonment.

SCHEDULE

Item No.

1. Barbituric acid and its salts and derivatives except Secobarbital and Pentobarbital and their salts

2. Butorphanol and its salts

3. Chlorphentermine and its salts

4. Diethylpropion and its salts [Amfepramone]

5. Methylphenidate and its salts

6. Phentermine and its salts

7. Thiobarbituric acid and its salts and derivatives SOR/78-427, s. 10; SOR/79-753, s. 1.

PART J RESTRICTED DRUGS

DIVISION 1

General

J.01.001. In this Part,

"institution" means any institution engaged in research on drugs and includes a hospital that is licensed by a province, a university, a department or agency of the Government of Canada or of a province or any part thereof; ("Stablissement")

"licence" means a licence issued under section J.01.007; ("licence")

"licensed dealer" means a holder of a licence; ("distributeur autorisS")

"permit" means a permit issued under section J.01.005; ("permis")

"qualified investigator" means, in respect to a restricted drug, a person who

(a) is employed by or is connected with an institution, or

(b) is engaged in research in an institution in respect of that drug, E/NL.1980/45-48 Page 76

and whose use and possession of that drug is authorized by the Minister pursuant to section J.01*018;• ("chercheur competent")

"practitioner" means a person who is registered and entitled under the laws of a province to practise the profession of medicine; ("praticien")

"test kit" means an apparatus

(a) that contains reagent systems or buffering agents or both,

(b) that is used in thecourse of a chemical or analytical procedure for medical, laboratory, industrial, educational or research purposes,, and

Possession

J.01.002. The following persons may have a restricted drug in their possession;

(a) a licensed dealer; '

(b) a qualified investigator if he has possession for the purpose of and in connection with research in an institution;

(c) an analyst, inspector, member of the Royal Canadian Mounted Police, constable, peace officer, member of the staff of the Department of National Health and Welfare or officer of a court, if such person has possession for the purpose and in connection with his employment; and

(d) a person authorized by the Minister pursuant to section J.01.033.

Licences, Permits and Licensed Dealers

J.01.003. Subject to this Part, no person other than a licensed dealer shall manufacture, import, export or sell a restricted drug.

J.01.004. No licensed dealer shall import or export a restricted drug without a permit.

J.01.005. The Minister may, upon application therefor, after such investigation as he deems proper and subject to such terms and conditions as he deems proper,, issue to any licensed dealer a permit for the importation or exportation of a restricted drug.

J.01.006. An application for a permit shall be in a form approved by the Minister.

J.01.007. The Minister may, upon application therefor and after such investigation as he deems proper, issue a licence to a person to deal in a restricted drug where that person, in the opinion of the Minister, is qualified to be a dealer in that drug.

J.01.008. An application for a licence shall be in a form approved by the Minister.

J.01.009. The Minister may impose such restrictions and conditions on a licensed dealer as he deems necessary for the control of a restricted drug.

J.01.010. A licensed dealer may at any time make an application to the Minister to amend his licence in order to become a licensed dealer in respect of a restricted drug other than a restricted drug specified in his licence or to change the terras or conditions of his licence. E/NL.1980/45-48 Page 77 :•,

J.01.Oil. A licensed dealer may, subject to the terms and conditions of his licence, manufacture or sell only the restricted drugs specified in his licence.

J.01.012. The Minister may revoke or suspend a licence or permit issued under this Part if the person to whom it was. issued has failed to comply with any term or condition thereof or any provision of this Part, or in the opinion of the Minister is no longer • able to so comply.

J.01.013. Every licence expires on the December 31 following;the day on which it was issued.

J.01.014. A permit is valid only for the particular importation or exportation in respect of which it was issued.

Sale of a Restricted Drug

J.01.015. An institution may, in a form approved by the Minister, make an application to a licensed dealer or to the Minister with respect to the purchase of a restricted drug

(a) for clinical use in the institution by qualified investigators for the purpose of determining the hazards and efficacy of the drug; or

(b) for laboratory research in the institution by qualified investigators.

J.01.016. Where a licensed dealer receives an application made pursuant to section J.01.015, he shall, before selling a restricted drug to the institution that made the application

(a) supply the Minister with a copy of the application; and

(b) obtain the written authority of the Minister to make the proposed sale of the restricted drug.

J.01.017. An application made pursuant to section J.01.015 shall contain

(a) the name and the address of the institution seeking to purchase the drug;

(b) the names and qualifications of the qualified investigators who will use and be in possession of the drug;

(d) the quantity of the drug required;

(e) the dosage form of the drug required by the institution; and

(f) the name of the licensed dealer from whom the purchase of the drug will be made.

J.01.018. Where the Minister receives from an institution an application or a copy of an application made pursuant to section J.01.015, he may, subject to such qualifications and limitations as he deems proper, authorize

(a) the sale to the institution by a licensed dealer of the restricted drug applied for in such quantity and such dosage form as he deems proper; and

(b) qualified investigators to make clinical use of the restricted drug in the institution or to carry out laboratory research with the restricted drug in the E/NL.1980/45-48 Page 78

institution and to possess the restricted drug for the purposes of such use or research.

J.01.019. An institution shall use a restricted drug only for the purpose and in accordance with the protocol therefor set out in the application respecting that restricted drug made pursuant to section J.01.015.

J.01.020. Where a licensed dealer is authorized under section J.01.018, to sell a restricted drug, he may, notwithstanding section C.08.002, sell that drug subject to any qualifications or limitations imposed by the Minister.

Records and Inspection

J.01.021. Every institution shall maintain, in a form satisfactory to the Minister, records respecting

(a) the amount of every restricted drug received by the institution;

(b) details of the use of restricted drugs in the institution;

(d) full clinical data with respect to the use of every restricted drug received by the institution.

J.01.022. Every institution shall make its records referred to in section J.01.021 available to the Minister upon his request and shall permit such inspection of the institution, respecting its use of restricted drugs, as the Minister may require.

J.01.023. Every licensed dealer shall maintain a record of

(a) the name, quantity and form of any restricted drug received by him, the name and address of the person who supplied it and the date upon which it was received;

(b) the name, quantity and form of any restricted drug supplied by him, the name and address of the person to whom it was supplied and the date upon which it was supplied;

(d) the name, quantity and form of any restricted drug manufactured by him and the date any restricted drug manufactured by him was placed in stock; and

(e) the name, quantity and form of any restricted drug he has in stock.

J.01.024. Every licensed dealer and every person who has been a licensed dealer shall keep the record referred to in section J.01.023 on the premises described in the licence that was issued to him or in such other place as may be approved by the Minister, for a period of at least two years and shall keep such record in a form that will facilitate an audit thereof being made at any time.

J.01.025. Every person who deals in a restricted drug shall, at the request of the Minister, permit an inspection of

(a) the premises used or intended to be used in connection with restricted drugs;

(b) the process and conditions of manufacturing and storing restricted drugs; E/NL.1980/45-48 Page 79

(d) the records relating to the manufacturing and storing of restricted drugs.

J.01.026. Every person who deals in a restricted drug shall

(a) supply such information in such form as the Minister may require respecting the dealings of any person in the restricted drug;

(b) produce to an inspector any books, records or documents required to be kept under this Part;

(d) permit an inspector to check all stocks of restricted drugs located on the premises described in his licence.

J.01.027. Every licensed dealer shall notify the Minister forthwith of any change

(a) in his technical staff concerned with a restricted drug;

(b) in the premises in which a restricted drug is manufactured or stored; and

J.01.028. Every person who is in possession of a restricted drug and every institution to which the sale of a restricted drug has been authorized by the Minister shall

(a) provide such protection against loss or theft of the restricted drug as may be required by the Minister; and

(b) report forthwith to the Minister and to local law enforcement authorities any loss or theft of a restricted drug.

J.01.029. Where a licensed dealer delivers a restricted drug, he shall

(a) take such steps as are necessary to insure the safekeeping of the drug during transit; and

(b) use such methods of transportation as will insure that an accurate record.is kept of the drug while in transit and of the signatures of any persons having charge of the drug until it is delivered to the consignee.

Packaging and Labelling

J.01.030. Every restricted drug that is sold to an institution shall be securely packed by the licensed dealer who sells the drug in such a manner that the package cannot be opened without breaking the seal.

J.01.031. The provisions of section C.01.004 do not apply to a restricted drug.

J.01.032. Every package that contains a restricted drug shall be labelled so that the inner and outer labels thereon show

(a) the proper name or, if there is no proper name, the common name of the drug;

(b) the net contents of the package; E/NL.1980/45-48 Page 80

(d) the lot number of the drug;

(e) the words "]'Restricte d Drug"; and

(f) the name and address of the manufacturer of the drug.

J.01.032.1. Section J.01.032 does not apply to a test kit that contains a restricted drug where a registration number has been issued for the test kit pursuant to section J.01.033.3 and has not been cancelled pursuant to section J.01.033.4.

J.01.033. (l) Where he deems it to be in the public interest and the interests of science, the Minister may authorize in writing

(a) any person to possess a restricted drug,

(b) any person to administer a restricted drug to an animal, and

(c) any practitioner of medicine to administer, give, furnish, distribute or deliver a restricted drug to any person authorized pursuant to paragraph (a) to possess a restricted drug for the purposes and subject to the conditions set out or referred to in the authorization.

(2) The Minister may, at any time, revoke the authorization referred to in subsectibn (1) and require any person in possession of a restricted drug pursuant to that authorization to deliver the restricted drug to the Minister or his agent.

(3) Notwithstanding anything in these Regulations, a person may, for the purpose of identification or analysis thereof, give or deliver a restricted drug that he has in his possession to

(a) a practitioner; or

(b) an agent of a practitioner, which agent has been authorized by the Minister pursuant to subsection (1) to be in possession of that restricted drug for that purpose.

(4) Where an agent of a practitioner has received a restricted drug pursuant to subsection (3), he shall forthwith give or deliver it

(a) to the practitioner of whom tie is the agent; or

(b) to the Minister or his agent.

1 ;(5) A practitioner who has received a restricted drug pursuant to subsection (3) or (4) shall forthwith give or deliver it .

(a) for the purpose of identification or analysis thereof, to a person authorized by the Minister pursuant to subsection (l) to be in possession of that restricted drug for that purpose; or

(b) to the Minister.

(6) Sections J.01.021 and J.01.022 apply with such modifications as the circumstances may require to every person who has received a restricted drug pursuant to E/NL.1980/45-48 Page 81 : .-o.: this section other than a person to whom a restricted drug has been administered pursuant to paragraph (1) (c).

Test Kits Containing Restricted Drugs

J.01.033.1. Any person may sell, possess or otherwise deal in a test kit that contains a restricted drug if

(a) a registration number has been issued for the test kit pursuant to section J.01.033.3;

(b) the test kit bears, on its external surface,

(i) the manufacturer's name,

(ii) the trade name or trade mark, and *

(iii) the registration number issued therefor pursuant to section J.01.033.3;

(c) the test kit is sold, possessed or otherwise dealt in for the purpose of medical, laboratory, industrial, educational or research use; and

(d) the registration number has not been cancelled pursuant to section J.01.033.4.

J.01.033.2. , The manufacturer of a test kit that contains a restricted drug may apply for a registration number therefor, by submitting to the Director an application containing

(a) particulars of the design and construction of the test kit;

(b) a detailed description of the restricted drug and other substances, if any, contained in the test kit, including the qualitative and quantitative.composition of each component;

(d) any further information and material that the Minister may require in order to satisfy himself that the test kit is one for which a registration number may be ; issued..

J.01.033.3. Where, on application under section J.01.033.2, the Minister is satisfied that the test kit to which the application applies will only be used for medical, laboratory, industrial, educational or research use and that it

(a) contains a restricted drug and one or more adulterating or denaturing agents in such a mannner, combination, quantity, proportion or concentration that the preparation or mixture has no significant drug abuse potential, or

(b) contains such small quantities or concentrations of any restricted drug as to have no significant drug abuse potential and is a test kit id«jifci|£^d. in the, table to this section, the Minister may issue a registration number for the test kit, which shall be a number preceded' by Che letters "TK". ^ E/NL.1980/45-48 Page 82

TABLE

Column I Column II Column III

Names of Manufacturer Names of Test Kit Form of Product

J.01.033.4. The Minister may cancel the registration number for a test kit if the test kit is removed from the market by the manufacturer or if, in the Minister's opinion,

(a) it is necessary to cancel the registration number in the interest of public health; or

(b) the test kit is used or is likely to be used for any purpose other than medical, laboratory, industrial, educational or research use.

Prescribed Manner of Notice of Application for an Order of Restoration

J.01.035. (1) For the purposes of section 45 of the Act, notice of application for an order of restoration shall be given to the Crown in writing by registered mail addressed to the Minister of National Health and Welfare at Ottawa.

(2) The notice referred to in subsection (1) shall be mailed not less than 15 clear days prior to the date the application is to be made to the magistrate and shall specify

(a) the magistrate to whom the application is to be made;

(b) the time and place where the application is to be heard;

(d) the evidence upon which the applicant intends to rely to establish that he is entitled to possession of the restricted drug or other thing referred to in paragraph (c).

Note 8

1/ E/NL.1961/115.

2/ E/NL.1961/116; E/NL.1979/40.

3/ This text is available in the files of the United Nations Division of Narcotic Drugs.

4/ E/NL.1961/117; E/NL.1979/39.