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

Home , Hydromorphone, Thebacon

UNITED NATIONS E/NL. 1987/73-74 27 March 1990 ENGLISH ONLY * 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.

FEDERAL REPUBLIC OF GERMANY

Communicated by the Government of the Federal Republic of Germany

NOTE BY THE SECRETARIAT

(a) 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. (b) Only passages directly relevant to the control of narcotic drugs or psycho• tropic substances have been reproduced in this document. Non relevant parts of laws and regulations have been deleted by the Secretariat; such deletions are indicated by [...].

INDEX

page

E/NL.1987/73 First Ordinance Amending the Regulations of Narcotic Drugs Legislation (First Narcotic Drugs Legislation Amending Ordinance) 6 August 1984

E/NL.1987/74 Second Ordinance Amending the Regulations of 14 Narcotic Drugs Legislation (Second Narcotic Drugs Legislation Amending Ordinance) 23 July 1986

* Note by the Secretariat: The present document is a direct reproduction of the texts communicated to the Secretariat.

v.90-83299 E/NL.1987/73-74 page 2

E/NL.1987/73 First Ordinance Amending the Regulations of Narcotic Drugs Legislation (First Narcotic Drugs Legislation Amending Ordinance) 6 August 1984

On the basis of section 1 paragraph 2 and section 13 paragraph 3 of the Narcotics Act of 28 July 1981 (Federal Law Gazette I, p. 681, 1187) the Federal Government, with the consent of the Bundesrat, hereby orders as follows:

Article 1

Amendment of the Schedules of the Narcotics Act

The Schedules of the Narcotics Act shall be amended as follows:

1... Schedule I of the Narcotics Act shall be amended as follows:

a) The narcotic drugs etorphine and phendimetrazine shall be deleted with all particulars given.

b) The following narcotic drugs shall be inserted in alphabetical order:

"Dimethoxybromampheta= mine (DOB) 2,5-Dimethoxy-4-bromamphetamine Ethylpiperidyl* benzilate (JB 318) 1-Ethyl-3-piperidylbenzilate . Methoxyamphetamine (PMA) 4-Methoxy-oC-methylphenethylamine Me th oxyme thylene- 3-Methoxy-<*.-methyl-4,5-methylenedioxyamphetamine (MMDA) dioxyphenethylamine Methylenedioxyamphet• amine (MDA) o( -Methyl-3,4-methylened-ioxyphene= thylamine Methylpiperidyl^ benzilate (JB 336) 1-Methyl-3-piperidylbenzilate Racemethorphan (-)-3-Methoxy-17-methylmorphinan Trimethoxyamphetamine 3,4,5-Trimethoxy-^-methyl- (TMA) phenethylamine".

c) The scientific designation of the narcotic drug etoxeridine shall be indicated in the following version: "Ethyl- {l-/2-(2-hydroxyethoxy)ethyl7-4-phenyl-4-piperidin- carboxylate}". E/NL.1987/73-74 page 3

Schedule II of the Narcotics Act shall be amended as follows: a) The narcotic drug papaver somniferum shall be deleted with all particulars given. b) The following narcotic drugs shall be inserted in alphabetical order:

"Cetobemidon 1- /4-(3-Hydroxyphenyl)-1-methy1- 4-piper idyl./-1 -propanon Dextropropoxyphene ( + )-(!-Benzyl-3-dimethylamino- 2- methyl-1-phenylpropyl)propionate - except in preparations containing without any additional substance listed in Schedules I to III, up to 2.5 per cent in oral application or, per dosage unit, up to 135 milligrammes of dextj propoxyphene, calculated as a base - Levorphanol (-)-17-Methyl-3-morphinanol Phendimetrazine 3,4-Dimethyl-2-phenylmorpholin^'. c) The position of the narcotic drug papaver orientale (papaver bracteatum) shall be indicated in the following version:

"Papaver orientale plants and plant segments of (Papaver bracteatum) plants belonging to the species of papaver orientale, except their seeds; if they serve ornamental purposes, narcotic drug regulations shall only apply to import, export and transit".

Schedule III Part A of the Narcotics Act shall be amended as follows: a) The following narcotic drugs shall be deleted with all particulars given:

Cetobemidoru?, dextropropoxyphene, levorphanol. b) The position of the narcotic drug tilidine shall be indi• cated in the following version: E/NL.1987/73-74 page 4

"Tilidine Ethyl-(2-dimethylamino-1-phenyl- 3-cyclohexen-1-carboxylate) - except in preparations containing without any additional substance listed in Schedules I to III, up to 615 milligrammes•of tilidine per dosage unit, .calculated as a base and related to this quantity, not less than 7.5 per cent of naloxone-hydro= chloride. These preparations, however, are subject to the narcotic drugs regulations governing import, export and transit -".

c) The following narcotic drugs shall be inserted in alphabetical order:

"Alfentanil Nj(l-/2-(4-ethyl-5-oxo-2-tetrazol 1 -y 1) e thy 1 - 4 - me thoxyjaethy 1 - 4 - piperidyl} propionanilide Buprenorphin 1 7-Cy_clopropylmethyl-4, 5c-epoxy- 7<*.-/ (Sj_-1 -hydroxy-1,2, 2-trimethyl- propy]V-6-methoxy-6,14-endo- ethanomorphinan-3-ol Etorphine 4 , 5oc-Epoxy-7cv- (1 -hydroxy-1 -methylbutyl) -6-methoxy-17-methyl-6,14- endo-ethenomorphinan-3-ol Nabilone (+)-trans-3-(1,1-Dimethylheptyl)- 7,8,10,10a-tetrahydro-1-hydroxy- 6,6-dimethyl-6H-dibenzo/fa ,d/pyran- 9 (6aH_) -on Papaver somniferum plants and plant segments of plants belonging to the species of papaver somniferum, except their seeds; if they serve ornamental purposes,and if morphine has been extracted by a method authorized by the Federal Health Office, narcotic drug regulations shall only apply to import, export, transit, cultivation and production".

Schedule III Part B shall be amended as follows:

a) The following narcotic drug shall be inserted in- alphabetical order:

"Pentazocine 1,2,3,4,5,6-hexahydro-6,11- dimethyl-3(3-methyl-2-butenyl)- 2,6-methano-3-benzazocin-8-ol". E/NL.1987/73-74 page 5

b) The scientific designation of the narcotic drug pento• barbital shall be indicated in the following version: "5-Ethyl-5-(1-methylbutyl)-barbituric acid".

5. In Schedule III Part C the exceptions for the narcotic drug barbital shall be amended by the following wording:

"- except in preparations which without being administered to human or animal bodies exclusively serve diagnostic or analytic purposes and which per dosage unit contain up to 25 g barbital or barbital sodium or a mixture of these two substances -".

Article 2

Trade in New Narcotic Drugs and Exempted Preparations

(1) A person who on coming into force of this ordinance without belonging to the group of persons mentioned in section 4 of the Narcotics Act participates in the trade in narcotic drugs (section 3 paragraph 1 (1) of the Narcotics Act) or in the trade in exempted preparations (section 3 paragraph 1 (2) of the Narcotics Act) with the substances mentioned below:

1. Alfentanil 2. Buprenorphin 3. Dimethoxybromoamphetamine (DOB) 4. EthylpiperidyleHbenzilate (JB 318) 5. Methoxyamphetamine (PMA) 6. Methoxymethylenedioxyamphetamine (MMDA) 7. Methylenedioxyamphetamine (MDA) 8. Methylpiperidyl0*benzilate (JB 336) 9. Nabilon 10. Pentazocine 11. Racemethorphan 12. Trimethoxyamphetamine (TMA)

shall be entitled to do so up to 31 December 1984. In case he applies for a licence pursuant to section 3 paragraph 1 of the Narcotics Act before 1 January 1985 this entitlement shall, continue until the application is dismissed finally and absolutely. E/NL.1987/73-74 page 6

(2) A person who at the time this ordinance comes into force, as a person entitled within the meaning of the 1st sentence of paragraph 1, has in safekeeping narcotic drugs as described in the a.m. paragraph shall be under the obligation by 31 December 1984

1. to report to the Federal Health Office these narcotic drugs indicating kind and amount and

2. to hand them over or sale them to the holder of a licence pursuant to section 3 paragraph 1 of the Narcotics Act, to the operator of a pharmacy or a veterinary house dispensary or to a person untitled pursuant to - the 2nd sentence of paragraph 1 or to destroy them under the terms of section 16 of the Narcotics Act if he does not file an application pursuant to the 2nd sentence of paragraph 1.

A person who according to sentence 1 (2) acquires narcotic drugs shall have to inform the Federal Health Office by 31 March 1985 on the dispensing party as well as kind and quantity of the narcotic drug acquired.

(3) If the narcotic drugs specified in paragraph 1 are packed for dispensing to the consumer without the packages complying with the requirements pursuant to section 14 of the Narcotics Act, they shall still be allowed to be dispensed in these packages until 31 July 1985.

(4) If the narcotic drugs specified in paragraph 1 are not stored and secured in the manner required in section 15 of the Narcotics Act, they shall still be allowed to be stored in the manner admissible so far until 31 July 1985. The 1st sentence shall not apply to storage in pharmacies, veterinary house dispensaries and on merchant ships. E/NL.1987/73-74 page 7

Article 3

Amendment of the Narcotic Drugs Prescription Order

The Narcotic Drugs Prescription Order of 16 December 1981 (Federal Law Gazette I, p. 1427) shall be amended as follows:

1. Section 2 paragraphs 1 to 3 shall be worded as follows:

"(1) A medical practitioner shall be allowed to prescribe for a patient on any single day:

a) one of the following narcotics in compliance with maximum quantities established below and other restrictions concerning purpose of application, content and dosage form (other restrictions):

1. Amphetamine 200 mg 2. Buprenorphin 4 mg 3. Dextromoramide 100 mg 4 . Hydrocodone 200 mg 5. Hydromorphone 30 mg 6. Levomethadone 60 mg 7. Methamphetamine 100 mg 8. Methaqualone 6 ,000 mg 9. Methylphenidate 200 mg 10. Morphine 200 mg 11. Nabilon 36 mg 12. Normethadone 200 mg 13. Opium, standardized 2 ,000 mg 14. Opium extract 1 ,000 mg 15. Tincture of opium 20 ,000 mg 16. Native opium alkaloids in their natural mixing ratio, calculated as morphine 200 mg 17. Oxycodone 200 mg 18. Papaver somniferum, calculated as morphine 200 mg 19. Pentazocine 700 mg 20. Pethidine 1 ,000 mg 21 . Phenmetrazine 600 mg 22. Piritramide 220 mg 23. Thebacon 200 mg 24 . Tilidine 1 ,050 mg

or E/NL.1987/73-74 page 8

b) a preparation containing one or two narcotics specified in Schedule III Part B, except pentazocine and pento• barbital, or Part C of the Narcotics Act.

(2) If in cases of particularly severe illnesses the quantity to be administered to the patient requires the maximum quantity established under paragraph 1 (a) to be exceeded, the practitioner shall be allowed to prescribe for this patient on any single day: 1. one of the narcotic drugs specified in paragraph 1 (a) nos 2,3,5,6,10,13 to 20,22 and 24, up to four times the established maximum quantity or

2. if the patient is under long-term treatment, the narcotic drug specified in paragraph 1 (a) no 10, up to ten times the established maximum quantity.

In such cases he shall have to provide the prescription with a hand-written note saying "quantity medically justified". A prescription according to point 2 shall only be admissible for oral application as a solution up to a content of 4 per cent adding at least 0.05 per cent quinine hydrochloride and 1 per cent carboxymethylcellulose-sodium; it shall have to be provided with directions for use indicating that the solution is intended "only for oral application" and at what intervals it has to be taken. Notwithstanding the first sentence he shall be allowed to prescribe the solution specified in the third sentence in the-quantity required for three days.

(3) As his own surgery supply -a medical practitioner shall be allowed only to prescribe on any single day:

1. one of the narcotic drugs specified in paragraph 1 up to the established maximum quantity or a preparation containing one or two of the narcotic drugs specified in Schedule III Part B, except pentazocine and pentobarbital, or Part C of the Narcotics Act,

2. up to 30 mg alfentanil for pre-medication and anaesthesia including neuroleptanalgesia, E/NL.1987/73-74 page 9

3. up to 1,000 mg cocaine for surgeries on the eye, larynx, nose, ear, throat or jaw as a) solution up to a content of 20 per cent, or

b) eye tablet or ointment up to a content of 2 per cent,

4. up to 10 mg fentanyl for pre-medication and anaesthesia including neuroleptanalgesia, for diagnostic surgeries and in intensive care medicine and

5. up to 2,500 mg pentobarbital for pre-medication and anaesthesia".

In section 2 paragraph 4 the quotation "nos 2 and 3" shall be replaced by the quotation "nos 2 to 5".

Section 3 paragraphs 1 and 2 shall be worded as follows:

"(1) A dental surgeon shall be allowed to prescribe for a patient on any single day: a) one of the.following narcotic drugs in compliance with the maximum quantities established below:

1. Amphetamine 200 mg 2. Buprenorphin 4 mg 3. Dextromoramide 100 mg 4. Hydrocodone 200 mg 5. Hydromorphone 30 mg 6 . Levomethadone 60 mg 7. Methamphetamine 100 mg 8. Methaqualone 6,000 mg 9. Methylphenidate 200 mg 10. Morphine 200 mg 1 1. Normethadone 200 mg 1.2. Opium, standardized 2,000 mg 13. Opium extract 1 ,000 mg 14. Opium tincture 20,000 mg 15. Native opium alkaloids in their natural mixing ratio, calculated as morphine 200 mg 16. Oxycodone 200 mg E/NL.1987/73-74 page 10

17. Pentazocine 700 mg 18. Pethidine 1 ,000 mg 19. Phenmetrazine 600 mg 20. Piritramide 220 mg 21. Thebacon 200 mg 22. Tilidine 1,050 mg

or b) a preparation containing one or two of the narcotic drugs specified in Schedule III Part B, except pentazocine and pentobarbital, or Part C of the Narcotics Act.

(2) As his own surgery supply a dental surgeon shall only be allowed to prescribe on any single day:

2. up to 30 mg alfentanil for pre-medication and anaesthesia including neuroleptanalgesia,

3. up to 5 mg fentanyl for pre-medication and anaesthesia including neuroleptanalgesia and

4. up to 2,500 mg pentobarbital for pre-medication and anaesthesia".

4. In section 3 paragraph 3 the quotation "no 2" shall be replaced by the quotation "nos 2 to 4".

5. Section 4 paragraphs 1 to 3 shall be worded as follows:

"(1) A veterinary surgeon shall be allowed to prescribe for an animal on any single day:

a) one of the following narcotic drugs in compliance with the maximum quantities established below:

1. Amphetamine 1,000 mg 2. Buprenorphin 4 mg E/NL.1987/73-74 page 11

3. Dextromoramide 100 mg 4. Hydrocodone 200 mg 5. Hydromorphone 30 mg 6. Levomethadone 250 mg 7. Methamphetamine 100 mg 8. Methaqualone 6,000 mg 9. Methylphenidate 200 mg 10. Morphine 500 mg 11 . Normethadone 200 mg 12. Opium, standardized 12,000 mg 13. Opium extract 6,000 mg 14. Opium tincture 120,000 mg 15. Native opium alkaloids in their natural mixing ratio, calculated as morphine 1 ,500 mg 16. Oxycodone 300 mg 17. Pentazocine 700 mg 18. Pethidine 1 ,000 mg 19. Phenmetrazine 600 mg 20. Piritramide 220 mg 21 . Thebacon 200 mg 22. Tilidine 1 ,050 mg

or b) a preparation containing one or two of the narcotic drugs specified in Schedule III Part B, except pentazocine and pentobarbital, or Part C of the Narcotics Act.

(2) If in cases of particularly severe illnesses the quantity to be administered to the animal requires the maximum quantity established in paragraph 1 (a) to be exceeded, the veterinary surgeon shall be allowed to prescribe for this animal on any single day only one of the narcotic drugs specified in paragraph 1 (a) nos 2,3,5,6,10,12 to 18, 20 and 22 up to twice the established quantity. In such cases he shall have to provide the prescription with a hand-written note saying "quantity veterinarily justified".

(3) As his own surgery supply a veterinary surgeon shall only be allowed to prescribe on any single day: E/NL.1987/73-74 page 12

3. up to 1,000 mg cocaine for surgeries on the eye.as

a) solution up to a content of 20 per cent, or

b) eye tablet or ointment up to a content of 2 per cent,

4. up to 30 mg etorphine for immobilization of zoo and wild animals,

5. up to 10 mg fentanyl for pre-medication and anaesthesia including -neuroleptanalgesia, for diagnostic surgeries and for immobilization and

6. up to 4 0,000 mg pentobarbital for pre-medication and anaesthesia as well as for putting down animals".

6. In section 4 paragraph 4 the quotation "nos 2 and 3" shall be replaced by the quotation "nos 2 to 6".

7. In section 6 paragraph 1 the sub-paragraphs 4, 5 and 7 shall be worded as follows:

"4. directions for use specifying the single and the daily dose; in the cases contained in section 2 paragraph 2 (2) also the intervals of application,

5. for prescriptions of alfentanil, cocaine, etorphine, fentanyl and pentobarbital the purpose of administration, 7. in the cases referred to in section 2 paragraph 2 and section 4 paragraph 2 the annotations stipulated thereunder."

8. Section 8 paragraph 2 sentence 2 shall be worded as follows: E/NL.1987/73-74 page 13

"He shall be allowed to prescribe for merchant ships 1. having no ship's doctor only the narcotic drugs specified in section 2 paragraph 1 (a) nos 5, 13 and 20,

2. having a ship's doctor only the narcotic drugs specified in section 2 paragraph 1 (a) nos 4,5,7,10,13,17 and 20."

9. Section 10 sentence 1 (2)(a) shall be worded as follows:

"a) contrary to section 2 paragraphs 1, 2 sentences 1, 3 or 4 or section 3 paragraph 1 for a patient,".

Article 4

Berlin Clause

Pursuant to section 14 of the Third Transitory Law in conjunction with section 41 sentence 2 of the Narcotics Act this order shall •also apply in the Land of Berlin.

Article 5 Entry into Force, Transitory Provision, Replaced Provisions

(1) This Ordinance shall enter into force on 1 September 1984.

(2) Plants or plant segments of plants belonging to the species of papaver somniferum, if they serve ornamental purposes and if morphine has not been extracted, shall until 31 March 1985 be allowed to be marketed under the previous provisions by persons who have neither imported nor cultivated them.

(3) The Ninth Ordinance Concerning Substances Placed on the Same -Footing as Narcotic Drugs of 15 June 1981 (Federal Law Gazette I, p. 529) shall be repealed.

Bonn, 6 August 1984 For the Federal Chancellor The Federal Minister of Posts arid Telecommunications Dr. Christian Schwarz-Schilling The Federal Minister for Youth, Family Affairs and Health GeiBler E/NL.1987/73-74 page 14

E/NL.1987/74 Second Ordinance Amending the Regulations of Narcotic Drugs Legislation (Second Narcotic Drugs Legislation Amending Ordinance) 23 July 1986

On the basis of section 1 paragraph 2.of the Narcotics Act of 28 July 1981 (Federal Law Gazette I, p. 681, 1187) the Federal Government, having heard experts, hereby orders as follows, on the basis of section 1 paragraph 3 of the Narcotics Act the Federal Minister for Youth, Family Affairs, Women and Health hereby orders as follows, on the basis of section 13 paragraph 3 of the Narcotics Act the Federal Government, with the consent of the Bundesrat, hereby orders as follows:

Article 1

Amendment of the Narcotics Act

The Narcotics Act amended by article 1 of the ordinance of 6 August 1984 (Federal Law Gazette, p.1081) shall be amended as follows:

1. In Schedule I the following narcotic drugs shall be inserted in alphabetical order:

Cathinone (S) -2-Aitiinopropiophenone Diirettoxyaii^etaiixLne (DMA) 2,5-Dimethoxy- c^netiiylriienetJiylamine Dimettoxyethylairphetamine (DOET) 4-Ethyl-2,5-diJietlToxy-oC-iriet±iylphenet±iylainine MetliylerKiLoxymethamphetaiaLne (MDMA) N ,d-Diirethyl-3,4-^iiethylendioxyphenet±iylainine

2. Schedule II shall be amended as follows: a) The position ofrthe narcotic drug papaver orientale (papaver bracteatum) shall be indicated in the following version: E/NL.1987/73-74 page 15

"Papaver bracteatum plants and plant segments of plants belonging to the species of papaver bracteatum,except their seeds, - except for ornamental purposes -" b) The following narcotic drug shall be inserted in alphabetical order:

Thebacon 4,5

3. Schedule III, Part A shall be amended as follows: a) The position of the narcotic drug opium shall be indicated in the following version:

"Opium the coagulated juice of plants belonging to the species of papaver somniferum

- except in preparations manufactured according to a homoeopathic processing method in particular according to the homoeopathic part of the pharmacopoeia if the final concentration does not exceed the sixth degree of dilution -."

b) The position of the narcotic drug papaver somniferum shall be indicated in the following version:

"Papaver somni- plants and plant segments of plants ferum belonging to the species of papaver somni• ferum, except their seeds - except for plants and plant segments cultivated for ornamental purposes (poppy straw) if morphine has been extracted by a method authorized by the Federal Health Office; in this case the narcotic drug regulations shall only apply to import, export and transit - E/NL.1987/73-74 page 16

except in preparations manufactured according to a homoeopathic processing method in particular according to the homoeopathic part of the pharmacopoeia if the final concentration does not exceed the fourth degree of dilution -."

c) The narcotic drug thebacon shall be deleted with all particulars given.

d) The following narcotic drug shall be inserted in alphabetical order:

Fenetylline 7- £2- L(cL-Methylphenetyl)aminc[J ethyl]theophilline

4. In Schedule III Part C the following narcotic drugs shall be inserted in alphabetical order:

Alprazolam 8-Chloro-1 -methyl-6-phenyl-4H-[5} triazolo 0,3-3-3 £l,4lbenzodiazepine

- except in preparations containing without any additional substance listed in Schedules I to III, up to 1 mg alprazolam per dosage unit. These preparations, howeve are subject to the narcotic drugs regula• tions governing import, export and transit -

Br omazepam 7-Bromo-1,3-dihydro-5- (2-pyridyl) -2H-1,4- benzodiazepin-2-one

- except in preparations containing without any additional substance listed in Schedules I to III, up to 12 mg bromazepam per dosage unit. These preparations,however are subject to the narcotic drugs regula• tions governing import, export and-transit • E/NL.1987/73-74 page 17

Camazepam (7-Chloro-1,3-dihydro-3-hydroxy-1-methyl-

5-phenyl-2H-1/4-benzodiazepin-2-one) d ime thy1carbamate(fester) - except in preparations containing without any additional substance listed in Schedules I to III, up to 20 mg camazepam per dosage unit. These preparations, how• ever, are subject to the narcotic drugs regulations governing import, export and transit - Chlordiazepoxide 7-Chloro-2-methylamino-5-phenyl-3H-1, 4- benzodiazepine-4-oxide - except in preparations containing without any additional substance listed in Schedules I to III, up to 40 mg chlordiazep• oxide per dosage unit. These preparations, however, are subject to the narcotic drugs regulations governing import, export and transit - Chlobazam 7-Chloro-1-methyl-5-phenyl-1H-1^-benzo• diazepine^ ,4(3H,5H)-dione - except in preparations containing without any additional substance listed in Schedules I to III, up to 30 mg chlobazam per dosage unit. These preparations, however, are subject to the narcotic drugs regulations governing import, export and transit - Clonazepam 5-(o-Chlorophenyl)-1,3-dihydro-7-nitro- 2H-1,4-benzodiazepin-2-one - except in preparations containing without any additional substance listed in Schedules I to III, up to 0.25 per cent as drip solution, but not more than 250 mg per package unit or up to 2 mg clonazepam per dosage unit. These preparations, hovv ever, are subject to the narcotic drugs regulations governing import, export and transit -

Clorazepate 7-Chloro-2,3-dihydro.2,2-dihydroxy-5-phenyl- TH-1,4-benzodiazepine-3-carboxylic acid - except in preparations containing without any additional substance listed in Schedules I to III, up to 50 mg per dosage unit, as a dry substance for parenteral application only up to 100 mg;dipotassium- clorazepate. These preparations, however, are subject to the narcotic drugs regulations governing import, export and transit - E/NL.1987/73-74 page 18

Clotiazepam 5-(o-Chlorophenyl)-7-ethyl-1,3-dihydro- methyl-2 H-thieno [2,3-<§ [1, 4*1 diazepin-2-one -except in preparations containing without any additional substance listed in Schedules I to III, up to 20 mg clotiazepam per dosage unit. These preparations, however, are subject.to the narcotic drugs regula• tions governing import, export and transit -

Cloxazolam 10-Chloro-11b-(o-chlorophenyl)-2,3,7,11b- tetrahydro-oxazolo £3,2-dJ (l ,4] benzodiazepin- 6(5H)-one Delorazepam 7-Chloro-5-(o-chlorophenyl)-1,3-dihydro-2H- 1,4-benzodiazepin-2-one

Diazepam 7- Chloro-1,3-dihydro-1-methyl-5-phenyl-2H- 1,4-benzodiazepin-2-one -except in preparations containing without any additional substance listed in Schedules I to III, up to 1 per cent as syrup or drip solution but not more than 250 mg per package unit or up to 20 mg diazepam per dosage unit. These prepara• tions, however, are subject to the narcotic drugs regulations governing import, export and transit -

Estazolam 8- Chloro-6-phenyl-4H-5-triazolo (4 , 3-<^ (j ,4] benzodiazepine

Ethylloflazepate Ethyl-7-chloro-5-(o-fluorophenyl)-2,3-dihydro- 2-oxo-1H-1,4-benzodiazepin-3-carboxylate

Fludiazepam 7-Chloro-5-(o-fluorophenyl)-2,3-dihydro-1- methyl-1H-1,4-benzodiazepin-2-one

Flunitrazepam 5-(o-Fluorophenyl)-2,3-dihydro-1-methyl-7- nitro-1H-l,4-benzodiazepin-2-one -except in preparations containing without any additional substance listed in Schedules I to III, up to 2 mg flunitrazepam per dosage unit. These preparations, how• ever, are subject to the narcotic drugs regulations governing import, export and transit -

Flurazepam fluorophenyl)-1,3-dihydro-2H-1,4- benzodiaz.epin-2-one -except in preparations containing without any additional substance listed in E/NL.1987/73-74 page 19

Schedules I to III, up to 30 mg flurazepam per dosage unit. These preparations, how• ever, are subject to the narcotic drugs regulations governing import, export and transit -

7-Chloro-1,3-dihydro-5-phenyl-1-(2,2,2- trifluoroethyl)-2H-1,4-benzodiazepin-2-one -except in preparations containing without any additional substance listed in Schedules I to III, up to 120 mg halazepam per dosage unit. These preparations, however, are subject :to the narcotic drugs regulations governing import, export and transit -

10-Bromo-11b-(o-fluorophenyl)-2,3,7,11b- tetrahydrooxazolo [3,2-d\ L~1 ,41 benzodiazepin- 6(5H)-one ~ ~ .

11 -Chloro-8 ,12b-dihydro-2 ,8-rdimethyl-12b- phenyl-4H- f 1 ,3] oxazirio [3,2-dj p , 4] benzodiazepin-4 ,7 (6H) -dione ~~ " -except in preparations containing without any additional substance listed in Schedules I to III,.up.to 45 mg ketazolam per dosage unit. These preparations, however, are subject to the narcotic drugs regulations governing import, export and transit -

6- (o-Chlorophenyl)-2, 4-dihydro (4-methyl3l- piperazinyl) methylene -8-nitro-1H-imidazo £j, 2-Jj (ji ,4j[ benzodiazepin-1-one - except in preparations containing without any additional substance listed in Schedules I to III up to 2.5 loprazolam per dosage unit. These preparations, however, are subject to the narcotic drugs regulations governing import, export and transit -

7- Chloro-5-(o-chlorophenyl)-1,3-dihydro- 3-hydroxy-2H-1,4-benzodiazepin-2-one - except in preparations containing without any additional substance listed in Schedules I to III, up to 2.5 mg lorazepam per dosage unit. These preparations, however, are subject to the narcotic drugs ^regulations governing import, export 'and transit -

7-Chloro-5-(o-chlorophenyl)-1,3-dihydro-3- hydroxy-1-methyl-2H-1,4-benzodiazepin-2-one - except in preparations containing without E/NL.1987/73-74 page 20

any additional substance listed in Schedules I to III, up to 2 mg lormetazepam per dosage unit. These preparations, how• ever, are subject to the narcotic drugs regulations governing import, export and transit -

Medazepam 7-Chloro-2,3-dihydro-1-methyl-5-phenyl- 1H-1,4-benzodiazepine - except in preparations containing without any additional substance listed in Schedules I to III, up to 10 mg medazepam per dosage unit. These preparations, however, are subject to the narcotic drugs regulations governing import, export and transit -

Nimetazepam 1.3- Dihydro-1-methyl-7-nitro-5-phenyl-2H- 1.4- benzodiazepin-2-one

Nitrazepam 1,3-Dihydro-7-nitro-5-phenyl-2H-1, 4- benzodiazepin-2-one - except in preparations containing without any additional substance listed in Schedules I to III up to 0.5 per cent as drip solution but not more than 250 mg per package unit or up to 10 mg nitrazepam per dosage unit. These preparations, however, are subject to the narcotic drugs regulations governing import, export and transit -

Nordazepam 7-Chloro-1,3-dihydro-5-phenyl-2H-1,4- benzodiazepin-2-one -except in preparations containing without any additional substance listed in Schedules I to III up to 0.5 per cent as drip solution but not more than 150 mg per package unit or up to 15 mg nordazepam per dosage unit. These preparations, however, are subject to the narcotic drugs regulations governing import, export arid transit -

Oxazepam 7-Chloro-1>3-dihydro-3-hydroxy-5-phenyl- 2H-1,4-benzodiazepin-2-one - except in preparations containing without lany additional substance listed in Schedules I to III, up to 50 mg oxazepam per dosage unit. These preparations, howeyer, are subject to the narcotic drugs regulations governing import, export and •, transit - ! E/NL.1987/73-74 page 21

Oxazolam 1O-Chloro-2,3,7,11b-tetrahydro-2-methyl-11b- phenyloxazolo p,2-d3 ft /43benzodiazepin- 6(5H)-one - except in preparations containing without any additional substance listed in Schedules I to III, up to 20 mg oxazolam per dosage unit. These preparations, however, are subject to the narcotic drugs regulations governing import, export and transit -

Pinazepam 7-Chloro-1,3-dihydro-5-phenyl-1-(2-propinyl)- 2H-1,4-benzodiazepin-2-one

Prazepam 7-Chloro-1-(cyclopropylmethyl)-1,3-dihydro- -5-phenyl-2H-1,4 -benzodiaz.epin-2-one

- except in preparations containing without any additional substance listed in Schedules I to III, up to 20 mg prazepam per dosage unit. These preparations, however, are subject to the narcotic drugs regulations governing import, export and transit -

Temazepam 7-Chloro-1,3-dihydro-3-hydroxy-1-methyl-5- phenyl-2H-1,4-benzodiazepin-2-one - except in preparations containing without any additional substance listed in Schedules I to III, up to 20 mg temazepam per dosage unit. These preparations, however, are subject to the narcotic drugs regulations governing import, export and transit -

Tetrazepam 7- Chloro-5-(1-cyclohexen-1 -yl)-1,3-dihydro- 1-methyl-2H-1,4-benzodiazepin-2-one - except in preparations containing without any additional substance listed in Schedules I to III, up to 50 mg tetrazepam per dosage unit. These preparations, however, are subject to the narcotic drugs regulations governing import, export and transit -

Triazolam 8- Chloro-6-(o-chlorophenyl)-1-methyl-4H-5-

-:except in preparations containing without any additional substance listed in Scheduled I to III, up to 1 mg triazolam per dosage unit. These preparations, how• ever, are subject to the narcotic drugs regulations governing import, export and transit - E/NL.1987/73-74 page 22

5. After section 40 the following section 40 (a) shall be inserted: "Section 40 a Trade in Further New Narcotic Drugs and Exempted Preparations

(1) A person who on 31 July 1986 without belonging to the group of persons mentioned in section 4 of the Narcotics Act participates in the trade in narcotic drugs (section 3 paragraph 1 (1) or in the trade in exempted preparations (section 3 paragraph 1 (2) with the below mentioned substances their isomers, esters, ethers, molecular compounds and salts:

1. Alprazolam 14. Fenetylline 27. Nordazepam 2. Bromazepam 15. Fludiazepam 28. Oxazepam 3. Camazepam 16. Flunitrazepam 29. Oxazolam 4. Chlordiazepoxide : 17.Flurazepa m 30. Pinazepam 5. Clobazam 18. Halazepam 31. Prazepam 6. Clonazepam 19. Haloxazolam 32. Temazepam 7. Clorazepate 20. Ketazolam 33. Tetrazepam 8. Clotiazepam 21. Loprazolam 34. Triazolam 9. Cloxazolam 22. Lorazepam 10. Delorazepam 23. Lormetazepam 11 . Diazepam 24. Medazepam 12. Estazolam 25. Nimetazepam 13. Ethylloflazepate ! 26. Nitrazepam

shall be entitled to do so up to 31 October 1986. In case he applies for a licence pursuant to section 3 paragraph 1 before 1 November 1986 this entitlement shall continue until the application is dismissed finally and absolutely. The person entitled pursuant to sentence 1 or 2 shall, like the holder of a licence,as from the time of this ordinance coming into force,be bound by all provisions of this act and the ordinances issued in connection therewith.

(2)- If the narcotic drugs specified in paragraph 1 are packed for dispensing to the consumer without the packages complying with the requirements pursuant to section 14, they shall still be allowed to be dispensed in these packages until 30 June 1987. E/HL.1987/73-74 page 23

(3) If the narcotic drugs specified in paragraph 1 are not stored and secured in the manner required in section 15, they shall still be allowed to be stored in the manner admissible so far until 30 June 1987. The ist sentence shall not apply to storage in pharmacies, veterinary house dispensaries and on merchant ships."

Article 2

Amendment of the Narcotic Drugs Prescription Ordinance

The Narcotic Drugs Prescription Ordinance of 16 December 1981 (Federal Law Gazette I, p. 1427) amanded by article 3 of the ordinance of 6 August 1984 (Federal Law Gazette I, p. 1081) shall be amended as follows:

1. Section 2 shall be worded as follows:

"Section 2

Prescribing by a medical practitioner

(1) A medical practitioner shall be allowed to prescribe for a patient on any single day: a) one of the following narcotics in compliance with the maximum quantities established below (single maximum quantities):

16. Tincture of opium 20,000 mg 17. Oxycodone 200 mg 18. Papaver somniferum/ calculated as morphine 200 mg 19. Pentazocine 700 mg 20. Pentobarbital 2,500 mg 21. Pethidine . 1,000 mg 22. Phenmetrazine 6 00 mg 23. Piritramide 220 mg 24. Tilidine 1,050 mg or b) one of the narcotic drugs specified in Schedule III Part B with the exception of pentazocine and pentobarbital or Part C of the Narcotics Act.

(2) In a case of a particularly severe illness, if the severeness of the illness requires it, a medical practitioner shall be allowed to prescribe on any single day for a patient whom he treats on a long-term basis, one of the below-mentioned narcotic drugs in the following manner:

1. Buprenorphin, dextromoramide, hydromorphone, levomethadone, morphine, standardized opium, opium extract, tincture of opium, oxycodone, pentazocine or pethidine up to twice the single maximum quantity in the amount required for up to 7 days,

2. Morphine .for oral application only a) as capsules or tablets with retarded active substance release per day of application up to five times,

b) as a solution up to a content of 4 per cent with at least 1 per cent carboxymethylcellulose-sodium being added, per day of application up to ten times the single maximum quantity in the amount required for up to 7 days or 3. Buprenorphin or morphine for peridural and intrathecal application per day.: of application up to the single maximum quantity in the amount required for up to 28 days. Narcotic drug dependence shall not be considered as a case of a particularly severe illness within the meaning of the first sentence. E/NL.1987/73-74 page 25

(3) As his own surgery supply the medical practitioner shall be allowed only to prescribe on any single day:

1. one of the narcotic drugs specified in paragraph 1 for up to the established maximum quantity or one of the narcotic drugs specified in paragraph 1 (b), 2. up to 275 mg alfentanil for pre-medication and anaesthesia including neurolepto- and on-demand analgesia,

3. up to 1,000 mg cocaine for surgeries on the eye,larynx, nose, ear, throat or jaw as a) solution up to a content of 20 per cent or b) eye tablet or ointment up to a content of 2 per cent and

4. up to 4 0 mg fentanyl for pre-medication and anaesthesia including neurolepto- and on-demand analgesia, for diagnostic surgeries and intensive-care medicine.

(4) The medical practitioner who heads or supervises a partial unit (ward) of a departmentized hospital or who heads or supervises an undepartmentized.hospital shall be allowed to prescribe as ward supply for the facility headed or super• vised by him, only the narcotic drugs specified in the paragraphs 1 and 3 nos 2 to 4 in consideration of the restrictions pursuant to paragraph 3 as regards intended purpose, content and dosage form. This shall also apply to an out-of-hospital medical practitioner who has a certain number of hospital beds reserved for him if the beds allocated to him are separated from other partial units as regards location or organisation."

2. Section 3 shall be worded as follows:

"Section 3

Prescribing by a dental surgeon

(1) A dental surgeon shall be allowed to prescribe for a patient on any, single day: E/NL.1987/73-74 page 26

a) one of the following narcotic.drugs in compliance with the maximum quantities established below (single maximum quantities):

1. Amphetamine 200 mg 2. Buprenorphin 10 mg 3. Dextromoramide 100 mg 4. Fenetylline 2,500 mg 5. Hydrocodone 200 mg 6. Hydromorphone 30 mg 7. Levomethadone 60 mg 8. Methamphetamine 100 mg 9. Methaqualone 6 ,000 mg 10. Methylphenidate 200 mg 11 . Morphine 200 mg 12. Normethadone 200 mg 13. Opium, standardized 2,000 mg 14. Opium extract 1 ,000 mg 15. Tincture of opium 20,000 mg 16. Oxycodone 200 mg 17. Pentazocine 700 mg 18. Pethidine 1,000 mg 19. Phenmetrazine 600 mg 20. Piritramide 220 mg 21 . Tilidine 1 ,050 mg or b) one of the narcotic drugs specified in Schedule III Part B with the exception of pentazocine and pentobarbital or Part C of the Narcotics Act.

(2) As his own surgery supply the dental surgeon shall be allowed only to prescribe on any single day: 1. one of the narcotic drugs specified in paragraph 1 (a) up to the established maximum quantity or one of the narcotic drugs specified in paragraph 1 (b), 2. up to 30 mg alfentanil for pre-medication and anaesthesia including neuroleptanalgesia, 3. up to 5 mg fentanyl for pre-medication and anaesthesia including neuroleptanalgesia and 4. up to 2,500 mg pentobarbital for pre-medication and anaesthesia. E/NL.1987/73-74 page 27

(3) The dental surgeon who heads or supervises a partial unit (ward) of a departmentized or who heads or supervises an undepartmentized hospital shall be allowed to prescribe as ward supply for the facility headed or supervised by him only the narcotic drugs specified in the paragraphs 1 and 2 nos 2 to 4 in consideration of the restrictions pursuant to paragraph 2 as regards the intended purpose. This shall also apply to an out-of-hospital dental surgeon who has a certain number of hospital beds reserved for him if the beds allocated to him are separated from other partial units as regards location or organisation." 3. Section 4 shall be worded as follows:

"Section 4 Prescribing by a veterinary surgeon

(1) A veterinary surgeon shall be allowed to prescribe for an animal on any single day: a) one of the following narcotic drugs in compliance with the maximum quantities established.below (single maximum quantities):

1. Amphetamine 1 ,000 mg 2. Buprenorphin 10 mg 3. Dextromoramide 100 mg 4. Fenetylline 2,500 mg 5. Hydrocodone 200 mg 6. Hydromorphone 30 mg 7. Levomethadone 250 mg 8. Methamphetamine 100 rag 9. Methaqualone 6 ,000 mg 10. Methylphenidate 200 mg 11. Morphine 500 mg 12. Normethadone 200 mg 13. Opium, standardized 12,000 mg 14. Opium extract 6,000 mg 15. Opium tincture 120,000 mg 16. Oxycodone 300 mg 17. Pentazocine 700 mg 18. Pethidine 1,000 mg 19. Phenmetrazine 600 mg 20. Piritramide 220 mg 21. Tilidine 1 ,050 mg or E/NL.1987/73-74 page 28

b) one of the narcotic drugs specified in Schedule III Part B with the exception of pentazocine and pentobarbial or Part C of the Narcotics Act..

(2) In case of a particularly severe illness, if the severeness of the illness requires it, a veterinary surgeon shall be allowed to prescribe for an animal on any single day one of the following narcotic drugs: Buprenorphin, dextromoramide, hydromorphone, levomethadone, morphine, opium,standardized,opium, extract, opium tincture, oxycodone, pentazocine or pethidine up to twice the single maximum quantities in the amount required for up to 7 days.

(3) As his own surgery supply the veterinary surgeon shall be allowed only to prescribe on any single day:

1. one of the narcotic drugs specified in paragraph 1 (a) up to the established maximum quantity or one of the narcotic drugs specified in paragraph 1 (b),

2. up to 30 mg alfentanil for pre-medication and anaesthesia including neuroleptanalgesia, 3. up to 1,000 mg cocaine for surgeries on the eye as a) solution up to a content of 20 per cent, or b) eye tablet or ointment to a content of 2 per cent, 4. up to 30 mg etorphine for immobilization of animals kept in the zoo , in the circus or in game preserves, to be administered personally or in the presence of the prescribing person,

5. up to 10 mg fentanyl for pre-medication and anaesthesia including neuroleptanalgesia, for diagnostic surgeries and for immobilization and

6. up to 40,000 mg pentobarbital for pre-medication and anaesthesia as well as for putting down animals. E/NL,1987/73-74 page 29

(4) The veterinary surgeon who heads or supervises a partial unit (ward) of a departmentized veterinary hospital or who heads or supervises an undepartmentized veterinary hospital shall be allowed to prescribe as ward supply for the facility headed or supervised by him,only the narcotic drugs specified in the paragraphs 1 and 3 nos 2,3,5 and 6 in consideration of the restrictions pursuant to paragraph 3 as regards intended purpose, content and dosage form."

4. Section 6 shall be amended as follows: a) In paragraph 1 no 3 (b) shall be replaced by (b) and (c):

"b) in a finished drug

designation, dosage form, weight quantity of the narcotic drug contained therein per package unit, in separate preparations per dosage unit, and the number of units;

c) in homoeopathic preparations

the degree of dilution of the narocitc drug contained therein and the weight quantity of the package unit, in separate preparations the number the dosage units, in a mixture of several preparations also the weight per• centage of the dilution contained in the narcotic drug."

b) In paragraph 1 nos 4 to 9 shall be worded as follows:

"4. the directions for use specifying the single and the daily dose, except in the cases referred to in section 2 paragraphs 2 no 3,

5. in the cases referred to in section 2 paragraph 2 the note saying "quantity.veterinarily justified" and, in any case, in addition, the statement as to for how many days the prescription is made,

6. the intended pjirpose in prescribing alfentanil, cocaine, etorphine and fentanyl as well as buprenorphin and morphine in the cases referred to in section 2 E/NL.1987/73-74 page 30

paragraph 2 no 3 and pentobarbital in the cases referred to in section 3 paragraph 2 no 4 and in section 4 paragraph 3 no 6,

7. the name of the prescribing medical practitioner or dental or veterinary surgeon, his professional title and address including phone number, in case of deputizing capacity also the note saying "in deputizing capacity, 8. in the cases referred to in section 2 paragraph 3, section 3 paragraph 2 and section 4 paragraph 3 the note saying "surgery supply" instead of the specifica• tions referred to in nos 1 and 4,

9. in the cases referred to in section 2 paragraph 4, section 3 paragraph 3 and section 4 paragraph 4 the name or the designation and the address of the facility for which the ward supply is intended instead of the specifications referred to in nos 1 and 4,".

c) Paragraph 2 shall be worded as follows: "(2) The specifications according to paragraph 1 shall be made with an indelible pencil or ball point pen and be identical on all parts of the narcotic drugs prescription form. In this respect, the specifications under the nos 2 to 6, 8 and 10 shall.be entered by the prescriber in his own haridwriting.. Any change of prescription with regard to the specifications under paragraph 1 nos 2 to 6 shall be entered by the prescriber, in his own handwriting, on all parts of the narcotic drugs prescription form and be confirmed by his signature. The specifications under paragraph 1 nos 1,7 with the exception of the note saying "in deputizing capacity" as well as no 9 may also be entered by another person, in typing or with stamps."

5. Section 8 paragraph 2 sentence 2 shall be worded as follows: E/NL.1987/73-74 page 31

"For merchant ships he may prescribe only the following narcotic drugs: 1. Hydromorphone, Opium, standardized, Pentazocine and Pethidine for merchant ships which have no ship's doctor,

2. Hydrocodone, Hydromorphone, Methamphetamine, Morphine, Opium, standardized, Oxycodone, Pentazocine and Pethidine for merchant ships which have a ship's doctor."

Section 10 sentence 1 shall be amended as follows: a) In number 2 (a) to (c) shall be worded as follows:

"2. a) contrary to section 2 paragraph 1 or 2 sentence 1 or section 3 paragraph 1 for a patient, b) contrary to section 2 paragraph 3, section 3 para• graph 2 or section 4 paragraph 3 for his surgery supply or c) contrary to section 4 paragraph 1 or 2 for an animal". b) Number 3 shall be worded as follows: "3. contrary to section 2 paragraph 4, section 3 para• graph 3 or section 4 paragraph 4 prescribes a) narcotic drugs for institutions other than those specified thereunder, bj narcotic drugs other than those specified thereunder or

c) narcotic drugs specified thereunder disregarding other restrictions."

After section 12 the following section 12a shall be inserted: E/NL.1987/73-74 page 32

"Section 12a Transitional Provision

The narcotic drugs "thebacon" and "a preparation containing native opium alkaloids in their natural mixing ratio calculated as morphine" may be prescribed by the medical practitioner, the dental or veterinary surgeon until 31 July 1988 pursuant to the provisions valid so far."

Article 3

New Version Authorization

The Federal Minister for Youth, Family Affairs, Women and Health may publish in the Federal Law Gazette the text of Schedules I to III of the Narcotics Act as well as the text of the Narcotic Drugs Prescription Ordinance in the version in force as from 1 August 1986.

Article 4

Berlin Clause

Pursuant to section 14 of the Third Transitory Law in conjunction with section 41 sentence 2 of the Narcotics Act this ordinance shall also apply in the Land of Berlin.

Article 5

Entry into Force

This ordinance shall enter into force on 1 August 1986.

Bonn, 23 July 1986 Dr. Helmut Kohl Federal Chancellor Rita Sussmuth Federal Minister for Youth, Family Affairs, Women and Health