Regulation On Prescribing, Dispensing, And Proof Of The Fate Of Narcotic Drugs

Original Language Title: Verordnung über das Verschreiben, die Abgabe und den Nachweis des Verbleibs von Betäubungsmitteln

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now

Read the untranslated law here: http://www.gesetze-im-internet.de/btmvv_1998/BJNR008000998.html

Ordinance, prescribing, dispensing, and the proof of the fate of narcotic drugs (narcotic prescription regulation BtMVV) BtMVV Ausfertigung date: 20.01.1998 full quotation: "narcotic prescription regulation of 20 January 1998 (BGBl. I S. 74, 80), most recently by article 2 of the Decree of the 5th December 2014 (BGBl. I S. 1999) has been changed" stand: last amended by article 2 V v 5.12.2014 I 1999 for details on the stand number you see in the menu see remarks footnote (+++ text detection from) : 1.2.1998 +++) Regulation as article 3 V 2121-6-24/4 v. 20.1.1998 I 74 (BtMÄndV 10) by the Federal Government with the consent of the Federal Council adopted. It is according to article 6 clause 1 on the 1.2.1998 entered into force.

Section 1 principles (1) the narcotic drugs referred to in annex III of the Narcotic Drugs Act only as preparations are prescribed. The provisions of this regulation also apply to salts and molecule connections of narcotic drugs, medical, dental or veterinary are applied according to the findings of medical science. Unless otherwise determined in the individual case, the maximum quantity fixed for a narcotics also applies to its salts and molecular compounds.
(2) drugs for a patient or an animal and for the practical need of a physician, dentist, or veterinarian may be placed only on presentation of a manufactured from narcotic prescription (prescription), for the station needs, emergency requirements pursuant to § 5 c and the rescue service required according to § 6 paragraph 1 only upon presentation of a manufactured from narcotics request ticket (prescription for the station needs, the need for emergency and rescue service needs).
(3) the whereabouts and the inventory of narcotic drugs are continuously to prove: 1 in pharmacies and veterinary pharmacies of House, 2nd in practices of doctors, dentists and veterinary surgeons, 3 on stations of the hospitals and the animal clinics, 4th in retirement and nursing homes, hospices and institutions of specialized outpatient palliative care, 5th in equipment of rescue services, 6th in facilities according to § 5 paragraph 9 b and 7 on Kauffahrteischiffen , which lead to the national flag.

§ 2 may prescribe prescription by a physician (1) for a patient the doctor within 30 days from: a) up to two of the following narcotic drugs in accordance with the below stipulated limits: 1. Amfetamin 600 mg, 2 buprenorphine 800 mg, 2 a.
Cannabis extract (based on the content of ∆9-tetrahydrocannabinol) 1 000 mg, 3. codeine as substitution substances 40 000 mg, 3a.
Dexamfetamin 600 mg, 3B. slide morphine 30 000 mg, 4. dihydrocodeine as substitution substances 40 000 mg, 5. dronabinol 500 mg, 6 Fenethylline 2 500 mg, 7 fentanyl 500 mg, 7a.
Flunitrazepam 30 mg, 8 hydrocodone 1 200 mg, 9 Hydromorphone 5 000 mg, 10 Levacetylmethadol 2 000 mg, 11 Levomethadon 1 500 mg, 11a.
Lisdexamfetamindimesilat 2 100 mg, 12 methadone 3 000 mg, methylphenidate 13 2 400 mg, 14 (dropped out) 15 morphine 20 000 mg, a 4 000 mg, 16 opium and 17 opium extract 2 000 mg, 18 opium tincture 40 000 mg, 19 oxycodone 15 000 mg, 20 Pentazocine 15 000 mg, 21 pethidine 10 000 mg, 22 (fallen away) 23 Piritramide 6 000 mg, 23a.
Tapentadol 18 000 mg, 24 Tilidine 18 000 mg or b) one further in Appendix III of the Narcotic Drugs Act designated narcotic drugs except cocaine, Etorphine, remifentanil and sufentanil alfentanil.
(2) in justified individual cases, and while preserving the necessary security of narcotics traffic the physician for a patient who is in his treatment of duration of, shall, of prescribed narcotics, and 2. the established maximum residue limits, deviate from the provisions of paragraph 1 with respect to 1 the number. Such a prescription is to be marked with the letter "A".
(3) for its practical needs of the physician may narcotic drugs referred to in paragraph 1 as well as alfentanil, cocaine in interventions on the head as a solution up to the level of 20 per cent or as ointment up to a content of 2 per cent, remifentanil and sufentanil up to the amount of his average two-week demand, but at least the smallest packaging unit, prescribe. Stocks should not exceed the monthly needs of the physician for each narcotic. The doctor may prescribe up to the amount of his average monthly requirements diamorphine. The storage should not exceed the average two month's supply of the doctor for diamorphine.
(4) for the needs of the station, only the doctor may prescribe, who directs a hospital or a unit of a hospital or supervised in the absence of the Director. He may prescribe narcotic drugs referred to in paragraph 3 in accordance with the specified there restrictions on purpose, content and dosage form. This applies also to a document doctor if you allocated beds are spatially and organizationally by other units differentiated him.

§ 3 may prescribe prescription by a dentist (1) for a patient the dentist within 30 days from the: a) one of the following narcotic drugs in accordance with the below set levels: 1 buprenorphine 40 mg, 2. hydrocodone 300 mg, 3. Hydromorphone 1 200 mg, 4. Levomethadon 200 mg, 5 morphine 5 000 mg, 6 oxycodone 4 000 mg, 7 Pentazocine 4 000 mg, 8 pethidine 2 500 mg , 9 Piritramide 1 500 mg, 9a.
Tapentadol 4 500 mg, 10 Tilidine 4 500 mg or b) one further in Appendix III of the Narcotic Drugs Act designated narcotics other than alfentanil, Amfetamin, cocaine, Diamorphine, dronabinol, Etorphine, Fenethylline, fentanyl, Levacetylmethadol, methadone, methylphenidate, Nabilone, Normethadone, opium, Papaver somniferum, pentobarbital, remifentanil, secobarbital and sufentanil.
(2) for its medical supplies the dentist may prescribe but at least the smallest packaging unit, the narcotic drugs listed in paragraph 1 as well as alfentanil, fentanyl, remifentanil and sufentanil up to the amount of his average two week requirements. The storage should not exceed for each drug the month's supply of the dentist.
(3) for the needs of the station, only the dentist may prescribe, who directs a hospital or a unit of a hospital or supervised in the absence of the Director. He may prescribe narcotic drugs referred to in paragraph 2 in accordance with the specified there restrictions on purpose, content and dosage form. This applies also for a document dentist if you allocated beds are spatially and organizationally by other units differentiated him.

§ 4 may prescribe prescription by a veterinarian (1) for an animal the veterinarian within 30 days from: a) one the following narcotic drugs in accordance with the below stipulated limits: 1. Amfetamin 600 mg, 2 buprenorphine 150 mg, 3. hydrocodone 1 200 mg, 4. Hydromorphone 5 000 mg, 5. Levomethadon 750 mg, 6 morphine 20 000 mg, 7 opium, a 12 000 mg , 8 opium extract 6 000 mg, 9 opium tincture 120 000 mg, 10 Pentazocine 15 000 mg, 11 pethidine 10 000 mg of 12 Piritramide 6 000 mg of 13 Tilidine 18 000 mg or b) one further in Appendix III of the Narcotic Drugs Act designated narcotics other than alfentanil, cocaine, Diamorphine, dronabinol, Etorphine, Fenethylline, fentanyl, Levacetylmethadol, methadone, methaqualone, methylphenidate, Nabilone, oxycodone, Papaver somniferum, pentobarbital, remifentanil, secobarbital and sufentanil.
(2) in justified individual cases, and while preserving the necessary security of narcotics traffic the veterinarian in a particularly severe illness shall, of prescribed narcotics, and 2. the established maximum residue limits, deviate from the provisions of paragraph 1 with respect to 1 the number. Such a prescription is to be marked with the letter "A".
(3) for their practice needs the vet may the narcotic drugs listed in paragraph 1, as well as alfentanil, cocaine for local anesthesia during surgery on his head as a solution up to the level of 20 per cent or as ointment up to a content of 2 per cent, Etorphine only to the immobilization of animals, which are held at the Zoo, the circus, or wildlife enclosures through handwritten or being in the presence of the prescribing dose , Pentobarbital, remifentanil, fentanyl and sufentanil, up to the amount of his average two-week demand, but at least the smallest packaging unit, prescribe. The storage should not exceed the month's supply of the veterinarian for each drug.
(4) for the needs of the station, only the veterinarian may prescribe, who directs an animal clinic or a unit of a veterinary hospital or supervised in the absence of the Director. He may prescribe narcotic drugs, except Etorphine, referred to in paragraph 3 in accordance with the specified there restrictions on purpose, content and dosage form.

§ 5 prescribing substitution (1) substitution within the meaning of this regulation is the application of a prescribed drug in an opiate-dependent patients (substitution substances) to 1st treatment of opiate dependency with the aim of gradual recovering of narcotic abstinence including the improvement and stabilization of the health, 2. support treating severe disease existing next to the opiate-dependent or 3. reducing the risks of an opiate addiction during pregnancy and after the birth.
(2) for a patient, the doctor may prescribe a substitution substances under the conditions of § 13 para 1 of the Narcotic Drugs Act, if and as long as 1.
No medically accepted grounds for exclusion are the substitution, 2 includes the treatment required psychiatric, psychotherapeutic and psychosocial treatment and support measures, the doctor the reporting obligations has fulfilled 3. pursuant to article 5a, paragraph 2, the studies and surveys of the physician no findings have shown 4 that the patient a) receives from another doctor prescribed substitution substances, b) referred to in point 2 for necessary treatment and care measures permanently claim does not , c) substances used, whose Konsum endangers the purpose of the substitution type and quantity or d) the prescribed him substitution substances not used as intended, 5. the patient to the extent necessary, usually weekly, consulted the doctor and the doctor meets 6 an addictive therapeutic skills minimum requirements which are laid down by the medical associations according to the generally recognised State of medical science.
For the fulfilment of the admissibility conditions laid down in paragraphs 1, 2 and 4, letter c is governed by the generally recognised State of medical science.
(3) a physician, of the conditions referred to in paragraph 2 sentence 1 No. 6 not met may a substitution substances to prescribe for a maximum of three patients at the same time if 1 the conditions referred to in paragraph 2 sentence 1 No. 1 to 5 for the duration of the treatment these are met, 2 this at the beginning of treatment with a doctor, the minimum requirements referred to in paragraph 2 sentence 1 No. 6 meets (Konsiliarius) , votes and 3. has ensured that his patient at the beginning of treatment and at least once in the quarter will be presented to the Konsiliarius.
The doctor represented pursuant to sentence 1 by a doctor, who according to so apply sentence 1 Nos. 1 and 2 for the representatives referred to in paragraph 2 set also does not meet the conditions 1 number 6. A substituierender physician referred to in paragraph 2 shall in principle by another doctor, of the conditions set 1 number 6 meets, are represented under paragraph 2. Fails the physician pursuant to sentence 3 to appoint a representative, he can by a doctor, who referred to in paragraph 2 set the conditions not met 1 number 6, for a period of up to four weeks and will represent no more than a total of 12 weeks in the year. The representative doctor pursuant to sentence 4 matches with represented doctor substitution treatment prior to representation. Again while an unforeseen change of substitution therapy required, right to the representation of representatives pursuant to sentence 4 represented doctor off. A timely vote is not possible, refers to another doctor, the physician Representative pursuant to sentence 4 of the conditions referred to in paragraph 2 sentence 1 number 6 met, part a. Emergency decisions remain unaffected in all representation cases. On the above cooperation between the attending physician and the Konsiliarius and the represented person and the representative doctor in accordance with sentences 2 and 4, related correspondence is the documentation pursuant to section 10 to attach. The sentences 1 to 9 do not apply the paragraphs 9a for the treatment to up to 9 d.
(4) the prescribing of a substitution substances must be marked with the letter "S". As substitution substances, the doctor only 1 allowed preparations of Levomethadon, methadone and buprenorphine, 2. in justified cases codeine or dihydrocodeine, 3. diamorphine as medicines approved for substitution or 4th another substitution approved medicines prescribe. Set of 2 number 1, 2 and 4 above substitution substances may not for parenteral use intended be. In addition to the provisions of this regulation, the generally recognised State of medical science is decisive for the selection of means of substitution. For the prescription of diamorphine pursuant to sentence 3 do not apply 2 number the paragraphs 6 to 8.
(5) the doctor who prescribes a substitution substances for a patient, not the patient must give prescription except in the cases referred to in paragraph 8. The prescription must be presented set 1 designated staff of the pharmacy only by himself, his medical representatives or through the in paragraph 6. The doctor who prescribed Diamorphine, must submit the prescription only a pharmaceutical entrepreneur.
(6) the substitution of substances is a patient by the doctor to leave his medical representatives in practice or by the assigned by him or appointed and controlled medical, pharmaceutical or in State-approved facilities of addiction health care active and trained personnel for immediate consumption. The doctor has to make sure that the staff is assigned pursuant to sentence 1 professionally in the left to a substitution product for direct consumption. In the case of prescribing codeine or dihydrocodeine can the patient after the transfer are respectively the amount required for one day of the substitution fluid in small doses handed a dose for direct consumption and whose independent income allows him, if no evidence for a non-intended use of the substitution by the patient the doctor.
(7) the substitution substances is the patient in the practice of a physician, in a hospital or in a pharmacy or in another appropriate institution recognized for this purpose by the competent authority of the country or, in the case of a medically certified long-term care to leave a home visit for direct consumption. The doctor must store the required substitution substances in one of the institutions referred to in sentence 1 under its responsibility; the consent of the possessor of the respective premises shall remain unaffected. For evidence of the whereabouts and inventory, the §§ 13 and 14 shall apply mutatis mutandis.
(8) the doctor or his medical representatives in practice may by way of derogation from paragraphs 5 to 7 in cases in which the continuity of substitution treatment not otherwise can be guaranteed, required amount prescribe a substitution substances in up to two days the patient, which is left to a substitution substances pursuant to paragraph 6 for direct consumption, and allow its independent capture him , as soon as the course of treatment permits, risks of self - or third-party risk as far as possible excluded are as well as the security and control of narcotics traffic are not affected. Within a week the doctor no longer allowed the patients as a prescription pursuant to sentence 1 hand. This prescription is to identify sentence 1, the doctor with the letter "Z" without prejudice to paragraph 4.
As soon as and as long as the patient's condition has stabilized and a provision of substitution agent for direct consumption is no longer required, the physician may give the patient a prescription about the amount of substitution means required for up to seven days and allow its independent capture him. The handing over of the notes pursuant to sentence 4 is particularly not permitted if the studies and surveys of the doctor's findings showed that the patient 1 consumed substances, threatening him with the taking of the substitution, 2 taking into account the development of tolerance yet on a stable dose has been set or 3. abusive consumed substances.
In addition, the generally recognised State of medical science is decisive for the assessment of the course of treatment by the doctor. In the case of a stay of abroad of the patient, which already substitution substances be prescribed pursuant to sentence 4, the doctor, taking into account all requirements to ensure the supply, referred to in this paragraph can hand over the notes through a lot of substitution agent for a longer period than the period mentioned in clause 4 and allow its independent capture him. These securities may not exceed the amount of substitution means required for up to 30 days in a year. You are notified to the competent authority of the country. Each bond pursuant to sentences 1, 4 or 8 is handed over to the patient in a personal medical consultation.
(9) the attending physician before continuing the substitution on a narcotic prescription to issue a certificate of substitution has patients who temporarily or permanently change the practice of the physician. On the substitution certificate shall specify: 1 surname, name and address of the patient, intended for the substitution certificate is, 2 date of issue 3. the prescribed substitution substances and the daily dose, 4. beginning of prescribing and dispensing the paragraphs 1 to 7 and, where appropriate, the beginning of the prescribing according to paragraph 8, 5. validity: from/to, 6 issuing doctor's name, his occupation and address including phone number , 7 signature of issuing doctor.
The substitution certificate must be marked with the note "only for submission to the doctor". Part I of the substitution certificate receives the patient, part II and III retained the issuing doctor. After submission of the part I of the substitution certificate by the patients and review of the personal data by comparison with the identity card or passport of the patient can another doctor prescribing the means of substitution continue; This is only temporary, the other doctor has completed his prescribing in writing about the measures taken to inform immediately the doctor.
(9a) the substitution substances diamorphine for parenteral use may be prescribed to treat of a severe opiate addiction. The doctor may diamorphine only prescribe, if 1 he itself an addictive therapeutic qualification within the meaning of paragraph 2 sentence 1 number 6 has acquired, which extends to treatment with Diamorphine, or in the context of the pilot project "Heroingestützte treatment Opiatabhängiger" at least six months by doctors working 2 the patient was, an opiate addiction for at least five years, combined with serious somatic and mental disorders is currently mainly intravenous use , 3. proof of two unsuccessfully finished treatment of opiate dependence, of them exists a minimum six-month treatment referred to in paragraphs 2, 6 and 7 including psychosocial care measures, and the patient has reached the 23 age 4.
(9B) the treatment with diamorphine must be carried only in facilities where a permit has been issued by the competent authority of the country. If 1 is proved that the establishment in the local addiction help system is included, 2. be guaranteed is that the organisation has an appropriate human and material resources, 3 is a qualified person is responsible have been named (person in charge), for compliance with the requirements referred to in point 2, the requirements of the permit authority as well as the rulings of the monitoring authority, permission is granted.
(9c) DIA morphine may be prescribed only within the institution according to paragraph 9 b, administered, and left for direct consumption. Diamorphine may be used only under the supervision of the physician or qualified staff within this institution. In the first six months of treatment, measures of psychosocial care must take place.
(9 d) treatment with diamorphine is to check whether the conditions for the treatment still exist and that the treatment to continue after at the latest two years of treatment. Verified by obtaining a second opinion by a doctor, the qualification referred to in paragraph 2 has set 1 number 6, and which is not set up. Results in this review, that the conditions for the treatment are no longer given, DIA-morphine-based treatment is to stop.
(10) the physician has the fulfilment of its obligations according to the preceding paragraphs, as well as pursuant to section 5a paragraph 2 and 4 to the extent and according to the generally recognised State of medical science to document. The documentation is to present at the request of the competent authority of the country to the insight and analysis or to submit.
(11) the Medical Council can in guidelines the generally recognised State of medical science for 1 the fulfilment of the conditions of admissibility referred to in paragraph 2 sentence 1 No. 1, 2, and 4 letter c, 2. the selection of means of substitution after the evaluation of the previous success of treatment determine according to paragraph 8 set 1 and 4 set of 4 and 3. paragraph 4 as well as pursuant to section 10 issued guidelines for documentation. Compliance with the generally recognised State of medical science is suspected, if and to the extent the guidelines of the Federal Medical Association are been complied with paragraphs 1 to 3.
(12) the provisions of paragraphs 2 to 10 shall apply accordingly if the substitution substances from the stock of the practical needs or station needs to direct consumption left to or issued under paragraph 6 sentence 3.

§ 5a (1) substitution register leads the Federal Institute for drugs and medical devices (Federal Institute) a register with data about prescribing by means of substitution (substitution register) for the countries as body borrowed by the Federal Government. The data of the register of substitution may be used only to verify 1 prescribing the means of substitution by multiple doctors for the same patients and over the same period as soon as possible to prevent, 2. whether the doctors verschreibenden a substitution substances the minimum requirements according to article 5, paragraph 2, sentence 1 number 6 or the requirements according to § 5, paragraph 3, sentence 1 number 2 and 3 meet 3. prescribing substitution funds according to the instructions, as well as § 13 para 3 statistically analyze letter e of the Narcotic Drugs Act No. 3.
The Federal Institute meets organizational requirements for maintaining the substitution register.
(2) any physician who prescribes a substitution substances for a patient, the federal institution has in writing without delay or kryptiert electronically to report the following information: 1. the patient code, 2. the date of the first prescription, 3. the prescribed substitution substances, 4. the date of the last prescription, 5 name, first name, date of birth, official address and telephone number of the prescribing physician, as well as 6 in the case of prescribing according to § 5, paragraph 3, sentence 1 name , First name, business address and telephone number of the Konsiliarius.
The patient code is composed as follows: a) first and second place: first and second letters of the first name, b) third and fourth digit: first and second letter of the family name, c) fifth place: gender ("F" for female, "M" for male), d) sixth to eighth place: last digit of birth day, month and year.
It is not permissible to report the Federal Institute patient data transmitted free to air. The doctor has to check the personal data by comparison with the identity card or passport of the patient.
(3) the Federal Institute encrypted immediately the patient code referred to in paragraph 2 sentence 1 No. 1 according to one of the Federal Office for security in given information technology procedures in a cryptogram in the way that it it not or only with a disproportionately large expense can be recovered. The cryptogram is to save set 1 No. 2 to 6 together with the information referred to in paragraph 2 and to delete no later than six months after the announcement of the termination of the prescribing. The stored data and the encryption method must be protected by appropriate security measures against unauthorized inspection and use pursuant to sentence 1.
(4) the Federal Institute compares each newly saved cryptogram with the already existing. The patient code is no consensus emerges to delete immediately. Matches are available, the Federal Institute shall immediately inform each participating doctor patient code, date of the first prescription, along with the name and given name, business addresses and telephone numbers of other participating doctors. The doctors have to explain whether the patient code to assign same patients. If this is true, they have to vote, who will prescribe substitution substances in the future for the patients, and to inform of the result of the Federal Institute patient code. If this is not true, the doctors have it also to inform the Federal Institute patient code. The substitution register is immediately to clean up. If necessary, the Federal Institute shall inform the competent monitoring authorities of participating doctors immediately stop prescribing by means of substitution by multiple doctors for the same patients and over the same period.
(5) the medical associations have the Federal Institute on its request, specifying the date of birth, first name, name and official address referred to in paragraph 2 sentence 1 No. 5 or no. 6 of reported physician, immediately to report whether the doctor meets the minimum requirements according to article 5, paragraph 2, sentence 1 number 6. The medical associations have the Federal Institute immediately after the announcement the specification "Note: Suchttherapeutische is no longer qualifying before." to those doctors, which previously were, reported the Federal Institute of the medical associations to submit, who number 6 so far met the minimum requirements according to article 5, paragraph 2, sentence 1, but no longer meet. The Federal Institute for the purpose of the data clean-up of the medical associations may require messages to all Chamber members, who number 6 meet the minimum requirements according to article 5, paragraph 2, sentence 1, containing the following information: 1. name and first name, 2nd official address, 3. date of birth.
The Federal Institute contained in the database of the substitution register shall immediately inform the competent monitoring authorities of the countries about name, first name, address and telephone number of physicians who have prescribed a substitution substances according to § 5 paragraph 2, 1 and 2 which referred to in paragraph 2 sentence 1 No. 6 reported Konsiliarien, if the doctors referred to in paragraph 1 and 2 and Konsiliarien number 6 in connection with the data provided to the sentences 1 to 3 do not meet the minimum requirements according to article 5, paragraph 2, sentence 1.
(6) the Federal Institute informs the competent monitoring authorities to 30 June and 31 December of each year the following information contained in the database of the register of substitution: 1.
Name, first name, addresses and telephone numbers of doctors who have prescribed substitution substances, number of patients for the a doctor mentioned under number 1 or number 2 has committed 2. name, given name, addresses and telephone numbers of physicians who have prescribed substitution substances according to § 5, paragraph 3, sentence 1, 3. name, given name, addresses and telephone numbers of doctors who referred to in paragraph 2 sentence 1 number 6 as Konsiliarius have been reported, and 4. a substitution substances according to § 5 paragraph 2.
The competent monitoring authorities may at any time require appropriate information in individual cases by the Federal Institute.
(7) the Federal Institute informs the Supreme country health authorities in the respective countries as at 31 December of each year the following information contained in the database of the register of substitution: 1 the number of patients prescribed a substitution substances, 2 the number of physicians who have prescribed substitution substances according to § 5 paragraph 2, 3. the number of physicians who have prescribed substitution substances according to § 5, paragraph 3, sentence 1 , 4. the number of physicians who set 1 number 6 as Konsiliarius have been reported pursuant to paragraph 2, as well as 5 type and percentage of prescribed substitution substances.
On request, the top health authorities receive also broken down after monitoring areas the information listed in paragraphs 1 to 5.

§ 5b prescribing for patients in retirement or nursing homes, hospices and the specialized outpatient palliative care (1) who can doctor who prescribes a drug for a patient in a retirement or nursing home, a hospice or in the specialized outpatient palliative care, determine that the prescription is issued not the patient. In this case, the prescription may be presented only by him himself or by personnel trained by him or appointed his practice, elderly or at nursing home, the Hospice or the establishment of specialized outpatient palliative care in the pharmacy.
(2) the narcotic drugs is to give the patient by the doctor or staff appointed, trained and controlled the elderly or nursing home, the Hospice or the establishment of specialized outpatient palliative care set 1 in the case of paragraph 1 or to provide for direct consumption.
(3) the doctor may store in the case of paragraph 1 under his responsibility the narcotic of the patient in the elderly or nursing home, the Hospice or the establishment of specialized outpatient palliative care set 1; the consent of the possessor of the respective premises shall remain unaffected. For evidence of the whereabouts and inventory, the §§ 13 and 14 shall apply mutatis mutandis.
(4) narcotic drugs, which were stored and are no longer needed, can 1 another patient of that elderly or nursing home, this Hospice or this institution of specialized outpatient palliative care are prescribed by the doctor, 2. providing pharmacy for re-use in a retirement or nursing home, a hospice or the specialized outpatient palliative care facility are returned pursuant to paragraph 3 or 3 c paragraph 1 sentence 1 can be transferred to the emergency stock according to § 5.

§ 5c prescribing for the emergency needs in specialized outpatient palliative care and hospices (1) hospices and specialist outpatient palliative care facilities may provide a ready supply of narcotic drugs for the unpredictable, urgent and short-term needs of their patients (emergency supply) on their premises. Entitled the possibility pursuant to sentence 1 exercise are required 1 one or more doctors to employ, to prescribe 2. which are included in the supply of the emergency and the removal from the emergency provision by internal regulations with the doctors and nurses involved in the care of patients with drugs continuous verification of the drugs needed for the emergency stock, according to section 2, paragraph 4, sentence 2 , to ensure and 3rd with a pharmacy supplies for the emergency stock, as well as a minimum half-yearly review of emergency stocks in particular on their perfect condition and proper and safe storage in writing agree; the undersigned pharmacist in writing indicating the agreement of the competent authority of the country prior to the first delivery; § 6 paragraph 3 sentence 2 to 4 shall apply mutatis mutandis.
(2) or the doctors referred to in paragraph 1 sentence 2 No. 1 may prescribe narcotic drugs required for the emergency stock up to the amount of the average two week requirements, but at least the smallest packaging unit,. Stocks must not exceed the average monthly requirement for emergencies for each drug.

§ 6 find the application according to § 2 para 4 corresponding rules on prescribing for the station need prescription for facilities of the ambulance service (1) for prescribing the demand for narcotic drugs for facilities and units of equipment of rescue service (emergency medical services required).
(2) the carrier or the performing of the rescue service has to authorise a doctor to prescribe the necessary drugs according to § 2 para 4. The recording of fate and stocks of narcotic drugs is to lead to the articles 13 and 14 of the bodies and units of the facilities of the ambulance service by the respective doctor.
(3) the carrier or the performing of the rescue service has to arrange the delivery of prescriptions for emergency services requirements, including a minimum half-yearly review of narcotics supplies in the institutions or units of equipment of rescue service whose perfect condition, as well as proper and safe storage with a pharmacy in writing. With the review of the drug stocks, a pharmacist of the pharmacy is to hire. It is a protocol to make. To eliminate identified shortcomings, the pharmacist responsible for the validation has to set a reasonable time limit the carrier or the performing of the ambulance service and to inform the competent authority of the country in the event of non-compliance.
(4) in the event of a damage, required narcotic drugs by the competent senior ambulance pursuant to § 2 para 4 is to prescribe. Consumed narcotic drugs are combined to prove and to show the competent Land Authority stating the non-consumed narcotic drugs by conducting an ambulance immediately for damage. The competent authority of the country meets specifications for the whereabouts of the non-consumed narcotic drugs.

§ 7 prescription apply to merchant (1) for prescribing and dispensing of narcotic drugs for the equipment of Kauffahrteischiffen §§ 8 and 9. On the Narcotics recipes you are referred to in no. 4 to 6 information instead of in article 9, paragraph 1 in paragraph 4 above to get no. 1 and 5 prescribed.
(2) for the equipment of Kauffahrteischiffen, only a doctor appointed by the competent authority may prescribe narcotic drugs; He may prescribe the narcotic morphine for this purpose in invasion of the ship without ship's doctor. For the equipment of Kauffahrteischiffen at occupation of the ship with ship's doctor, and those who do not the Federal flag, others the narcotic drugs referred to in the annex III of the Narcotic Drugs Act may be prescribed.
(3) exceptionally narcotics for the equipment of Kauffahrteischiffen of a pharmacy may be placed initially without a prescription, if 1 the physician referred to in paragraph 2 in a timely manner is reached before the departure of the ship, 2. providing qualitative and quantitative only to replace a) consumed, b) become unusable or c) outside the scope of the Narcotic Drugs Act of ships flying the national flag , purchased and made known by the Federal Ministry of transport and digital infrastructure according to § 108 paragraph 2 sentence 1 of the maritime labour code according to the current state of medical knowledge is to change drugs, 3. the issuing before is satisfied that the existing narcotics match type and quantity with the entries in the narcotic drugs register of the vessel, and 4. the issuing after the maritime labour legislation responsible certify the reception of which for the proper functioning of medical care itself is.
(4) the certificate pursuant to paragraph 3 No. 4 must contain the following information: 1. identification of prescribed medicines according to § 9 para 1 No. 3, 2. quantity of dispensed medicines after § 9 para 1 No. 4, 3rd release date, 4. name of the vessel, 5 name of the shipowner, 6 home port of the vessel and 7. signature of the person responsible for medical care after the maritime labour legislation.
(5) the issuing has the certificate No. 4 pursuant to paragraph 3 to submit to the subsequent prescription the physician appointed by the competent authority without delay. This is obliged immediately to furnish the prescribing a narcotic prescription pharmacy, which has supplied the drugs according to § 7 para 3. The prescription is to be marked with the letter "K". The certificate is according to § 7 para 3 No. 4 to connect permanently with the remainder in the pharmacy of the prescription. If the requirements of paragraph 3 do not have Nos. 1 and 2, the competent authority shall notify without delay.
(6) for prescribing and dispensing of narcotic drugs for the equipment of ships which are not merchant, are to apply paragraphs 1 to 5 according to.

§ 8 narcotic prescription (1) Narcotics to patients, the medical supplies and animals may be prescribed only on a three-part official form (narcotic prescription). The narcotic prescription must be used only for prescribing other medicines, if this is done in addition to a drug. Parts I and II of the prescription is intended to the template in a pharmacy, in the case of the prescribing of diamorphine according to § 5, paragraph 9a for submission to a pharmaceutical entrepreneur, part III remains with the doctor, dentist, or veterinarian, to which the narcotic prescription has been issued.
(2) Narcotics recipes are issued by the Federal Institute for drugs and medicine products on request to the individual doctor, dentist, or veterinarian. The Federal Institute for drugs and medicine products can fail the issue, if there is reasonable suspicion that the narcotic recipes are not used the narcotics regulations according to.
(3) the numbered narcotics recipes are intended only to the requesting physician, dentist, or veterinarian, and may be transferred only in the representation. The unused narcotic recipes are at cessation of medical, dental, or veterinary activities to return the Federal Institute for drugs and medical devices.
(4) the doctor, dentist, or veterinarian has to secure the Narcotics prescriptions for theft. A loss is stating the recipe number notified to the Federal Institute for drugs and medical devices, which taught the Supreme authority of the country.
(5) the physician, dentist, or veterinarian has I to III of the incorrectly manufactured narcotic drugs recipes exhibition data or according to the requirements of the competent authority of the country mapped three years to maintain part III of the prescription and the parts and to submit at the request of the land authority according to § 19 para 1 sentence 3 of the Narcotic Drugs Act or to submit representative of this authority.
(6) except in the cases of § 5, sentence 1 may be prescribed narcotics to patients, the medical supplies and animals in emergencies under the limitation on the amount by way of derogation from paragraph 1 to the resolution of the emergency. Notes pursuant to sentence 1 are to provide with the information pursuant to § 9 para 1 and to be marked with the word "Emergency prescription". The Pharmacy has the prescribing physician immediately after submission of the emergency prescription and if possible before the delivery of anesthetic on the delivery to inform dentist or veterinary surgeon. This is obliged immediately to furnish the prescribing a narcotic prescription pharmacy, which has supplied the emergency prescription. The prescription is to be marked with the letter "N". The emergency prescription is to connect permanently with the remainder in the pharmacy of the subsequent prescription.

§ 9 information on the prescription of narcotic drugs (1) on the prescription of narcotic drugs shall be indicated: 1. name, surname and address of the patient, for which the drug is intended; When veterinary prescriptions, the nature of the beast, as well as name, surname, and address of the keeper, 2. date of issue, 3. drug identification, as far as this, one of the following is not clearly determined, each additional description and weight quantity of contained anesthetic per packing unit, in sectioned preparations of ever split form, dosage form, 4. amount of the prescribed medicinal in grams or milliliters, quantity of form split off, 5. instructions with single and day gift or in the case , that written instructions passed the patients, a note on these written instructions; in the case of article 5, paragraph 8 in addition the Empire period of substitution means days, 6 in the cases of § 2 para 2 sentence 2 and section 4 para 2 sentence 2 the letter "A" in the cases of § 5 para 4 sentence 1 the letter "S" in the cases of § 5 paragraph 8, sentence 1 in addition of the letter "Z" in the cases of § 7 paragraph 5 sentence 3 of the letter "K" , in the cases of § 8 6 set 5 the letter "N", 7. name of the prescribing physician, dentist, or veterinarian, his occupation and address including telephone number, 8 in the cases of § 2 para 3, § 3 para 2, and § 4 para 3 the note of "Medical supplies" instead of the information contained in paragraphs 1 and 5, 9 signature of the prescribing physician, dentist or veterinarian , in the representation of the note "i.V..
(2) the information referred to in paragraph 1 are permanently to be noted and must be consistently included on all parts of the prescription. The information can be made by a person other than the prescribing paragraphs 1 to 8. In the case of a change in the prescription, the prescribing physician has to note the change on all parts of the prescription of narcotic drugs and to be confirmed by his signature.

§ 10 narcotics request license (1) narcotics for the station required according to § 2 para 4, § 3, para. 3 and section 4, paragraph 4, the emergency need for section 5 c and the rescue service required according to § 6 paragraph 1 may be prescribed only on a three-part official form (anesthetic requirement licence). Parts I and II of the prescription for the station needs, the need for emergency and rescue service needs are to the template in the pharmacy part III, remains with the legitimate prescription doctor, dentist, or veterinarian.
(2) Narcotics request certificates are issued by the Federal Institute for drugs and medicine products on request to: 1 directs the doctor or dentist, of a hospital or a hospital, 2 3 a the veterinarian, who heads an animal clinic, responsible doctor according to § 5 c paragraph 1 sentence 2 number 1, 4. According to § 6 paragraph 2 commissioned the doctor of the rescue service or 5 according to § 6 paragraph 4 (3) the numbered narcotics request notes are intended only to be used in establishing the competent senior ambulance , for which they were requested. You may by the requesting physician, dentist or veterinarian to head units or to another contracted physician pursuant to § 5 c paragraph 1 sentence 2 No. 1 are passed. Of the disclosure is a proof to lead.
(4) part III of the prescription for the station needs, the need for emergency and rescue service needs and the parts I to III of incorrectly manufactured narcotic drugs request certificates, as well as the evidence referred to in paragraph 3 dentist or veterinary surgeon three years from the last entry are by the requesting physician, calculated to maintain and upon request according to § 19 para 1 sentence 3 of the Narcotic Drugs Act responsible authorities to submit the or submit representative of authorities.

Information on the narcotic request slip (1) on the narcotic request slip § 11 shall be indicated: 1 name or the name and address of the institution for which the drugs are intended, 2. date of issue, 3. designation of prescribed medicines according to § 9 para 1 No. 3, 4 amount of prescribed medicines according to § 9 para 1 No. 4, 5 name of the prescribing physician, dentist or veterinarian including phone number , 6 signature of the prescribing physician, dentist, or veterinarian, in the representation of the note "i.V..
(2) the information referred to in paragraph 1 are permanently to be noted and must be consistently included on every part of the prescription for the station needs, the need for emergency and rescue service needs. The information can be made by a person other than the prescribing according to paragraphs 1 to 5. In the case of a change in the prescription for the station needs, the need for emergency and rescue service needs, the prescribing physician has to note the change on all parts of the request certificate of narcotic drugs and to be confirmed by his signature.

§ 12 delivery (1) Narcotics may not be off subject to paragraph 2: 1 on a bond, a) the recognizable not could be made out according to §§ 1 to 4 or § 7 para 2 for the issuing, b) in whose making out a provision of § 7 para 1 sentence 2, the section 8 para 1 sentence 1 and 2 or article 9 was ignored , c) that more than seven days ago made out, except for import of a medicinal pursuant to § 73 para 3 medicines Act, or d) that is marked with the letter "K" or "N".
2. on a prescription for the station supplies, the need for emergency and rescue service needs, a) that recognizable not could be made out according to the sections 1 to 4, article 7, paragraph 1 or article 10 par. 3 of the transferor or b) whose making out a provision of § 10 para 1 or section 11; not sensitive
3. on a prescription according to § 8 para 6, the a)
not pursuant to sentence 2 is marked or b) has been issued more than a day ago
4. on a prescription are according to § 5 para 8, when she assembled in single doses and child packing.
(2) If securities and bonds for the station needs, the need for emergency and rescue service needs, that are an error recognizable for the issuing included, illegible or not fully comply with the requirements according to article 9, paragraph 1 or article 11, paragraph 1, of the issuing is entitled to make changes after consultation with the prescribing physician, dentist, or veterinarian. Information pursuant to § 9 para 1 No. 1 or § 11 para. 1 No. 1 may by the issuing amended or supplemented if the bearer of the prescription or prescribing for the station needs, the need for emergency and rescue service needs proves these data or credibly assured or the details are otherwise indicated. On prescriptions or prescriptions for the station needs, the need for emergency and rescue service needs, where a change is possible pursuant to sentence 1 not the prescribed narcotics or subsets thereof may be placed, if the bearer of credibly assured or otherwise evident, that exists in an urgent case, which requires the immediate application of anesthetic. In these cases, the pharmacy manager has immediately through the levy was to notify the prescribing; the necessary corrections on the prescription or prescription for the station needs, the need for emergency and rescue service needs are to carry out without delay. Changes and amendments pursuant to sentences 1 and 2, consultation pursuant to sentences 1 and 4 as well as charges are pursuant to sentence 3 by the transferor on the parts I and II, by the prescribing, except in the case of the set 2, part III of the prescription or prescribing for the station needs, the need for emergency and rescue service needs. The sentences 2 to 4 do not apply to the prescription of diamorphine.
(3) the issuing has on part I of the prescription or prescribing for the station needs, the need for emergency and rescue service needs permanently to indicate the following information: 1 name and address of the pharmacy, 2. closing date and 3 name characters of the transferor.
(4) the head of the Pharmacy has after dispensing data or according to the requirements of the competent authority of the country ordered three years to maintain part I, notes and prescriptions for the station needs, the need for emergency and rescue service needs and to submit the Federal Institute for drugs and medical devices or the land authority according to § 19 para 1 sentence 3 of the Narcotic Drugs Act upon request or present officers of these agencies. Part II is intended for clearing. Sentences 1 and 2 apply in the case of the tax of diamorphine for those responsible for Narcotics of the marketing authorisation according to.
(5) the veterinarian may emit from his medicine cabinet drugs only to the application when an animal is treated by him, and only in compliance with the regulations of § for prescribing § 1 and 4 para 1 and 2.

§ Immediately after inventory change official form to lead verification (1) which is detecting facilities referred to fate and inventory of the narcotic in the § 1 para. 3 13. Flashcards or narcotics books can be used with consecutively numbered pages. The recording can be performed also by means of electronic data processing, if at any time the expression of the stored information in the order of the official form is guaranteed. In the case of the Überlassens of a substitution product for direct consumption according to § 5, paragraph 6, sentence 1 or an anesthetic according to § 5 para 2 is the whereabouts are to demonstrate.
(2) the entries about additions, disposals and stocks of narcotic drugs and compliance the stocks with the listed references are 1 by the pharmacist for the pharmacy led by him, 2nd by the veterinarian for the veterinary medicine cabinet led by him and 3. in paragraphs 2 to 4 of referred to legitimate prescription doctor, dentist or veterinary surgeon for the practice or station needs, , commissioned 4 by one according to § 5c paragraph 1 sentence 2 No. 1 doctor for hospices and institutions of specialized outpatient palliative care as well as commissioned by the according to § 6 paragraph 2 doctor for facilities of the ambulance service, 5 by the person responsible for carrying out the medical care after the maritime labour legislation for the respective Kauffahrteischiff, which leads the Federal flag, 6 by the doctor in the event of the proof referred to in paragraph 1 sentence 4 , 7 by the responsible person in the sense of § 5 paragraph 9 b number 3 at the end of each calendar month to check and, if the stock has changed, to be confirmed by name character and Prüfdatum. In the event that verification by means of electronic data processing is carried out, is testing based on the month-end manufactured prints.
(3) the index cards, narcotics books or computer printouts referred to in paragraph 2 sentence 2 are three years, by the last entry to counting to keep facilities mentioned in § 1 para. 3. When a change in the management of a hospital pharmacy, a setting up of a hospital, a veterinary clinic or a change of the responsible physician pursuant to § 5 c paragraph 1 sentence 2 the date of delivery, as well as the passed stock are number 1 or § 6 paragraph 2 sentence 1 by the persons referred to in paragraph 2 note and confirm by signature. The flashcards, the Narcotics books and computer printouts are requested according to § 19 para 1 sentence 3 of the Narcotic Drugs Act responsible authorities to submit or present officers of the authority. In the meantime, to make preliminary records, that to add are to return of the card and anaesthetic books are.

§ 14 data regarding the verification (1) proof of fate and stocks of narcotic drugs are permanently to indicate for each narcotic: 1 name of medicinal products according to article 9, paragraph 1 No. 3, 2nd date of access or departure, 3. received or received from quantity and the resulting stock; Substances and preparations not split the amount of weight in grams or milligrams, in sectioned preparations the quantity; case of liquid preparations, which are applied in the context of treatment the quantity in millilitres, 4. name or company and address of the supplier or the recipient or the other origin or the other whereabouts, 5th in pharmacies in the case of the tax on prescription for patients as well as for the medical supplies the name and address of the prescribing physician, dentist or veterinarian and the number of the prescription of narcotic drugs , in the case of the prescription for the station needs, the need for emergency and rescue service needs the name of the prescribing physician, dentist or veterinarian and the number of the narcotic request token, 5a.
in hospitals, veterinary clinics, hospices as well as facilities of the name of the prescribing physician, dentist or veterinarian and the number of the narcotic request token, 6 at the pharmaceutical company in the case of the tax on prescription of diamorphine specialised outpatient palliative care and the rescue service in the case of the acquisition prescription for the station needs, the need for emergency and rescue service needs name and address of the prescribing physician and the number of the prescription of narcotic drugs.
The records in these are existence in units, establishments referred to in article 1, paragraph 3.
(2) in the case of the verification, the weight amount of anesthetic, which is included in overcrowding of dispensing container necessary for technical reasons, only taken into account if as a result of the finish is higher than access is case of liquid preparations. The difference is to be access with "Overcrowding".

Section 15 forms the Federal Institute for drugs and medicine products are out the official forms for prescribing (narcotic recipes and anesthetic requirement lights) and for the detection of fate and stock (index card and anaesthetic books) and makes them known in the Federal Gazette.

§ 16 offences according to section 29, subsection 1, sentence 1 No. 14 of the Narcotic Drugs Act will be punished, who prescribes 1 contrary to section 1, paragraph 1, sentence 1, also in conjunction with sentence 2, a narcotic as a preparation, 2. a) contrary to article 2, paragraph 1 or 2 sentence 1, § 3 para 1 or article 5, paragraph 1 or paragraph 4 sentence 2 for a patient, b) contrary to article 2, paragraph 3, sentence 1 , Section 3, paragraph 2, sentence 1 or § 4 para 3 sentence 1 for his medical supplies or c) contrary to § 4 paragraph 1 for an animal others as designated thereon narcotic drugs or within 30 days more as a narcotic, in the case of § 2 para 1 letter a more than two drugs, the fixed level, or non-compliance with the predetermined destinations or other limitations prescribes , 3. contrary to § 2 para 4, § 3 section 3 or section 4 para 4 a) narcotic drugs for other than those designated thereon, b) other than the designated thereon narcotics or c) prescribes there called narcotics, failure to comply with the mentioned restrictions or 4. contrary to section 7 paragraph 2 prescribes narcotics for the equipment of Kauffahrteischiffen, prescribed diamorphine 5. contrary to article 5, paragraph 9 c, set 1 , administered or leaves.

§ 17 offences
Any person within the meaning of § 32 para 1 No. 6 of the Narcotic Drugs Act who intentionally or recklessly 1 is contrary to article 5, paragraph 9, sentence 2 and 3 in conjunction with § 5 paragraph 12, section 5a (2) sentence 1 to 4, article 7, paragraph 1, sentence 2 or paragraph 4, article 8, paragraph 6, sentence 2, § 9 para 1, also in conjunction with article 2, paragraph 2, sentence 2 , Section 4, paragraph 2, sentence 2, section 5, subsection 4, sentence 1, § 7, paragraph 5, sentence 3 or § 8, paragraph 6, sentence 5, article 11, paragraph 1 or article 12 par. 3, a statement in the prescribed form, not, not, not fully or not makes, 2. contrary to § 5 para 10 or not completely documented the necessary measures or shall submit the documentation not to the review and evaluation of the competent authority of the country or submits , 3. contrary to § 8 para 1 sentence 1, also in conjunction with section 7, paragraph 1, prescribes drugs not on a valid drug prescription or contrary to section 10, paragraph 1, sentence 1 narcotic drugs not on a valid license of anesthetic requirement, certain narcotics recipes transfers 4. contrary to § 8 section 3 for its use or when the activity does not return the Federal Institute for drugs and medicine products, 5. contrary to § 8 para 4 secures narcotic prescriptions not for theft or not immediately displays a loss , 6 contrary to § 8 para 5, § 10 section 4 or section 12, paragraph 4, sentence 1 the there designated parts of the prescription or prescribing for the station needs, the need for emergency and rescue service needs not or improperly stored, 7 contrary to article 8, paragraph 6, sentence 4 not immediately goes after prescription pharmacy, 8 contrary to section 10 subsection 3 sentence 3 leads no evidence regarding the dissemination of narcotic drugs request certificates , 9 a provision of § 13 para 1 sentence 1, paragraph 2 or 3 or of section 14 on the management of records, their testing or storage contravenes or 10 contrary to article 5, paragraph 2, sentence 1 number 6 or paragraph 3 sentence 1 number 2 and 3, set 2 and 7 or set 5 and 6 or paragraph 9a sentence 2 number 1 a substitution substances prescribes , without the minimum qualification to meet or to include in the treatment without a Konsiliarius or without as a representative who does not meet the minimum requirements for the qualification to vote without the DIA-morphine-specific requirements for the qualification after paragraph 9a sentence 2 number 1 to meet or.

Article 18 transitional provisions (1) § 5, paragraph 3, sentence 2 shall apply to the prescription of a substitution product for Betäubungsmittelabhängige, codeine or dihydrocodeine was prescribed which before entry into force of this regulation to the substitution, from 1 January 2000.
(2) § 5 par. 7 No. 1 is also met if at least six months of codeine or dihydrocodeine for the purpose of substitution for a patient has been prescribed at the time of entry into force of this regulation in the same practice.