Read the untranslated law here: http://www.gesetze-im-internet.de/apobetro_1987/BJNR005470987.html
Regulation on the operation of pharmacies (pharmacy operating order - ApBetrO) ApBetrO Ausfertigung date: 09.02.1987 full quotation: "Pharmacy operational rules as amended by the notice of 26 September 1995 (BGBl. I p. 1195), most recently by Article 2a of regulation by March 6, 2015 (BGBl. I p. 278) is changed" stand: Neugefasst by BEK. v. 26.9.1995 I 1195;
Amended by art. 2a V v. 6.3.2015 I 278 for more information on the stand number you see in the menu see remarks footnote (+++ text detection from: 1.7.1987 +++) (+++ changes due to EinigVtr cf. §§ 2, 3, 17 & 35 +++) table of contents the first section general provision Article 1 scope § 1a definitions second section operation of public pharmacies section 2 pharmacy Director paragraph 2a of the quality management system section 3 Pharmacy staff section 4 texture, size and furnishings of the pharmacy operation room § 4a § 5 hygiene measures scientific and other AIDS § 6 General rules on the production and testing section 7 recipe medicines section 8 defective medicines § 9 (dropped out) § 10 (dropped out) § 11 precursors § 11a activities on behalf of § 12 testing of the finished medicinal products produced not in the Pharmacy and pharmacy-only medicine products § 13 containers § 14 labelling section 15 stock section 16 storage section 17 acquisition and distribution of medicinal products and medical devices § 18 importation of medicinal products article 19 acquisition and distribution of prescription veterinary medicines section 20 information and advice section 21 drug risks, treatment of not capable to transport medicines section 22 General documentation section 23 service section 24 recipe collection § 25 (dropped out) third section operation of hospital pharmacies section 26 applicable provisions of section 27 head of Hospital pharmacy section 28 staff of the hospital pharmacy section 29 rooms and setting up of the hospital pharmacy section 30 stockpiling in the hospital pharmacy section 31 levy in the hospital pharmacy section 32 verification of drug supplies and nonprescription medicine products on the stations of § 33 service of hospital pharmacy fourth section special provisions article 34 Patientenindividuelles points or blistering of medicines section 35 manufacture of pharmaceutical products for parenteral use fifth section misdemeanors, transitional and final provisions article 36 offences section 37 transitional provisions section 35a (dropped out) section 36 (dropped out) § 37 (dropped out) first section General provisions § 1 scope (1) this Regulation shall apply on the operation and the establishment of community pharmacies, including hospital-supplying pharmacies, branch - and emergency pharmacies and hospital pharmacies. Their rules set, how to make sure is the proper supply of the population with medicines and pharmacy-only medicine products.
(2) this Regulation shall not apply to the extent to pharmacy operation, when a permit has been issued according to § 13, § 52a or § 72 of the medicines Act.
(3) the medical devices operator Ordinance as amended by the notice of 21 August 2002 (Federal Law Gazette I p. 3396) and the medical security plan Ordinance of 24 June 2002 (BGBl. I p. 2131), each as amended, remain unaffected.
Article 1a definitions (1) end of hospital care pharmacies are public pharmacies which supply a hospital in accordance with § 14 paragraph 4 of the Pharmacy Law.
(2) pharmaceutical personnel are pharmacists, pharmaceutical technical assistant, pharmacist Assistant, pharmaceutical engineers, pharmacy Assistant, pharmaceutical assistants and persons who are in training to the pharmacist's profession or to the profession of pharmaceutical Assistant.
(3) pharmaceutical activity within the meaning of this regulation is: 1 the development and manufacture of medicines, 2. the testing of raw materials or medicinal products 3. the dispensing of medicinal, 4. the information and advice on medicines, 5. the review of medicines, as well as the observation, collection and evaluation of drug risks and medication errors in hospitals or in hospitals in accordance with article 14, paragraph 8 Pharmacy Law with regard to the supply of medicines equivalent facilities or in the equipment to be supplied within the meaning of section 12a of the pharmacy Act , 6. the medication management, which repeatedly analyzes the entire medication of the patient, including self-medication, with the objectives to improve drug therapy safety and the adherence by drug-related problems are detected and resolved.
(4) Patientenindividuelles is carried out on single request and patient-related manual repackaging of finished medicinal products for certain income times of the patient in a reusable container.
(That is 5) Patientenindividuelles and blistern made and patient-related manual or machine new packaging of finished medicinal products for certain income times of the patient in a non-reusable container on individual request.
(6) raw material is any substance used in the manufacture of a medicament or any preparation of materials, excluding packaging.
(7) primary packaging materials are containers or wrappings that come with the drugs into contact.
(8) formula medicine is a medicine in the pharmacy in individual cases on the basis of a prescription or any other requirement of the individual and will be made in advance.
(9) defective medicinal product is a medicinal product which is produced in the usual pharmacy operation in advance on a day in up to a hundred tax finished packs or one of these relevant quantities.
(10) Apothekenübliche goods are: 1. medical devices that the pharmacy duty are subject to 2 medium as well as objects and information media, which directly serve the health of people and animals or promote this, 3. means for body care, 4. test equipment, 5. chemicals, 6 reagents, 7 laboratory supplies, 8 pesticides and plant protection products 9 means the rearing of animals.
(11) Apothekenübliche services are services that serve the health of humans or animals or they promote; include in particular: 1 advising a) in health and nutrition questions, b) in the field of health education and information, c) to precautionary measures, d) on medical devices, 2. performing simple health tests, 3. patient-specific customizing of medical devices and 4. the placement of health-related information.
(12) in-process controls are checks to monitor and, if necessary, adjustment of process, carried out during the manufacture of a drug to ensure that the drug has the expected quality; in the manufacture of sterile medicinal products, in particular parenteral drugs, is the monitoring of the environment or the equipment part of in-process controls.
(13) critical pieces of equipment or devices are those that can come with the precursors or medicines in contact or have an another significant influence on the quality or safety of these products.
(14) calibration is a process by which under certain conditions the relationship is determined between on the one hand the values that are indicated by a measuring instrument or measuring system, or values, resulting from a material measurement and on the other hand, the corresponding values of a reference standard.
(15) qualification is providing documented proof allocated with high certainty that a specific piece of equipment or a specific ambient conditions for the manufacture or testing of the medicinal product meets the pre-determined quality characteristics.
(16) validation is the provision of documented evidence which indicates that by a specific process or a standard operating procedures a medicinal product is manufactured and tested, that corresponds to the pre-determined quality characteristics with high security.
(17) manufacture in the closed system is sterile raw materials or solutions in a pre autoclaved closed container, unless the content comes with the external environment in contact.
Second section the operation of community pharmacies section 2 pharmacy manager is (1) pharmacy Manager 1 at a pharmacy which is operated, according to § 1 para 2 of the Pharmacy Law the holder of the authorization pursuant to section 2 of the pharmacy Act, in the case of lease, the lessee, 2nd at a pharmacy or branch pharmacy, which is managed by section 13 or section 16 of the Pharmacy Law, the holder of the authorisation , 3rd at a pharmacy which is operated according to § 17 of the Pharmacy Law, hired by the competent authority and to the line pharmacist commissioned, 4th at a main pharmacy according to § 2 para 5 No. 1 of the pharmacy Act, the holder of the authorization according to § 2 para 4 of the pharmacy Act, 5th in a branch according to § 2 para 5 No. 2 of the pharmacy Act by the operator named responsible.
(2) the head of the Pharmacy has to guide the pharmacy personally. He is responsible for ensuring that the pharmacy in accordance with the applicable regulations is operated. In addition to the pharmacy manager referred to in paragraph 1, operators for compliance with the regulations for the operation of pharmacies is responsible the No. 5.
(3) the head of the Pharmacy has to display any more professional or commercial activity to the competent authority, before it is taken up.
(4) the head of the pharmacy may offer goods referred only to an extent in addition to medicines and pharmacy-only medicine products in § 1a paragraph 10 or offering which does not affect the proper operation of the Pharmacy and the primacy of the medicines supply order. Set 1 is the usual pharmacy services according to § 1a 11 accordingly apply to sales.
(5) the head of the pharmacy must be, unless he temporarily not even takes its commitment to the personal direction of the pharmacy, a pharmacist represented by. The representation must not exceed a total of three months in the year. The competent authority may allow a representation beyond this period, if an important reason in the person of the head of the pharmacy.
(6) can a pharmacy manager of his obligation fail to set 1 after paragraph 5, he can be represented by a pharmacist Assistant or pharmaceutical engineering provided it is suitable in particular with regard to his knowledge and skills for this and in the years prior to the Agency at least six months full-time in a public pharmacy or hospital pharmacy was busy. The pharmacy manager must be no longer than a total of four weeks in the year represented by pharmacist Assistant or pharmaceutical engineers. The head of the Pharmacy has to inform the competent authority, specifying the representative before the beginning of the representation. Sentences 1 to 3 do not apply to the representation 1 of the holder of a permit according to § 2 paragraph 4 of the pharmacy Act, 2nd head of a hospital serving pharmacy as well as the specific provisions of section 34 or the section 35 apply 3. head of a pharmacy on the.
(7) the pharmacist responsible for the representation or pharmacist Assistant pharmacy engineer has the duties of head of Pharmacy during the duration of the representation.
paragraph 2a of the quality management system (1) the head of the pharmacy must operate a quality management system according to type and scope of pharmaceutical activities. The quality management system must be used to set and documented operational procedures. The quality management system must ensure in particular that the medicinal products are manufactured according to the State of science and technology, tested, and stored, and that confusion be avoided, as well as an adequate consulting services is carried out.
(2) the pharmacy manager has to ensure that regular self inspections be carried out by pharmaceutical staff to review the operations and, if necessary, corrections are made within the framework of the quality management system. In addition, the pharmacy should participate in regular measures to external quality checks.
(3) the head of the pharmacy is responsible for ensuring that the checks and self inspections referred to in paragraph 2 as well as the affiliated, if necessary, measures are documented.
§ 3 may the Pharmacy staff Pharmacy staff (1) only in accordance with his training and used his knowledge and is regularly to teach about the care offered in the respective activities. The instruction must extend also to the theory and application of the quality management system as well as characteristics of the medicinal products which are manufactured, tested or stored.
(2) in order to guarantee of a proper operation of the pharmacy, the necessary staff, including the pharmaceutical personnel, must be available in sufficient numbers. In addition required for the supply of hospital staff emerges from nature and scope a medically appropriate and sufficient supply of hospital medicines and nonprescription medicinal products, taking into account the size, type and power structure of the hospital. Sentence 2 shall apply accordingly for the supply of equipment within the meaning of section 12a of the pharmacy Act.
(3) (dropped out) (4) which must review the analysis and advice within the framework of a medication management system made by a pharmacist of the pharmacy.
(5) it is forbidden to carry out pharmaceutical activities by persons other than pharmaceutical personnel or to run, unless otherwise provided by paragraph 5a. Each person must be the extent of the German language powerful and have knowledge of the law in Germany, as it is necessary for the performance of their respective duties. Pharmaceutical activities, carried out by pharmaceutical Assistant, pharmaceutical assistants, or persons who are in training to the pharmacist's profession or to the profession of pharmaceutical Assistant, are by the pharmacy manager to oversee or supervise from this by a pharmacist. Pharmaceutical assistants may emit no medicines.
(5a) the transfer including filling and packing or marking of medicines must be under the supervision of a pharmacist also performed by other than the pharmaceutical personnel, insofar as pharmacy aides, pharmacy technicians, pharmaceutical commercial clerk, as well as persons who are in training for the profession of pharmaceutical commercial employee,. May 1 in the manufacture and testing of medicinal products, 2. when examining the precursors, can also support the pharmaceutical personnel of the other personnel of the pharmacy referred to in sentence 1 3 operation, care and maintenance of equipment, 4. When filling and packing or marking of medicines as well as 5th in the preparation of pharmaceutical products to submit.
The staff used to manufacture pursuant to sentence 1 or support pursuant to sentence 2 must be appropriately qualified for these tasks and be instructed about the care offered in the respective activities proven to start and then continuously by the pharmaceutical personnel.
(6) for the supply of a hospital with the exception of the delivery of pharmacy manager may use only personnel, which is involved in its operation. Sentence 1 applies corresponding on the care of residents of a facility to be supplied within the meaning of section 12a of the pharmacy Act.
§ 4 texture, size and furnishings of the pharmacy operation room (1) the premises must according to type, size, number, location and Setup be suitable, to ensure a proper operation of the pharmacy, in particular the proper development, production, testing, storage, packaging, as well as a proper distribution of medicinal or delivering pharmacy-only medicine products, information and advice on medicinal products or medical devices, using the facilities of telecommunications,. (The premises are to disconnect a 1 through walls or doors) by otherwise commercially or professional premises, also in connection with activities for which the pharmacy manager has a permit according to § 52a of the medicines Act, and b) public traffic areas and shop streets, 2. through appropriate measures to prevent unauthorized access to protect sufficiently to illuminate 3. aerate and if necessary to air-condition , 4th in perfect structural and hygienic condition to keep and 5 so arranged that each room without leaving the pharmacy is reached (indoor unit).
Sentence 2 number 1 (a) shall not apply to the manufacture of pharmaceutical products for which a permit is required according to § 13 of the German medicines Act.
(2) the pharmacy must consist at least of an Office, a laboratory, sufficient storage space and a night-duty room. The laboratory must be equipped with a fume hood with suction device or an appropriate body, which performs the same function. The floor space of the premises referred to in sentence 1 must be at least 110 square meters. There are the separate rooms referred to article 34, paragraph 3 and article 35, paragraph 3, as well as rooms that are set 2 to separate number 1 (a) of the pharmacy premises referred to in paragraph 1, not to take into account when calculating the footprint. Article 29, paragraph 1 and 3 shall apply accordingly for serving hospital pharmacies.
(2a) that Office must have access to public traffic areas and should be barrier-free accessible. She must be designed so that the primacy of the medicines supply order is not affected and remains for the main tasks carried out in the Office, in particular the advice to patients and customers, enough space. The Offizin must be set up so that guarantees the confidentiality of advice, especially in places where medicines to customers are supplied, thus, prevent the listening of the consultation as far as possible by other customers.
an own workplace (2B) pharmaceuticals for making certain not to the parenteral application must be provided. The workplace is from at least three sides high space from other areas of the pharmacy to separate, unless this work is in an operating room, which serves at the same time only as a laboratory. His walls and surfaces, as well as the floor must be easy to clean, so that the environmental risk of contamination for the medicinal products to be manufactured is minimal. The workplace can be used for the production of medical products or common pharmacy goods according to § 1a paragraph 10 number 2, 3, or 9.
(2c) for the production of medicines, drugs or drug mixtures are, or for other drugs as a raw materials processing, a separate work space must be provided. Paragraph 2 sentence 2 and 3 shall not apply.
(2d) the storage room must be sufficiently large and allow for a correct storage of the stock held in the pharmacy or distributed products. It must be possible to a storage below a temperature of 25 degrees Celsius. For medicinal products or precursors that secrete number 7 are according to section 21 and for fake medicines which number 8 to be kept secured are according to § 21, a separate and appropriately labelled storage area must be provided. As far as medicinal products outside the pharmacy opening hours are delivered, the compliance with the required storage temperature for the medicinal product concerned must be constantly ensured; an access of by unauthorised persons must be excluded. Pharmacies that supply hospitals with medicines, have to provide for these medicinal separate storage rooms or at least separate and labelled storage areas.
(3) a branch pharmacy must consist of at least an Offizin, sufficient storage room, and a night-duty room. Paragraph 2 sentence 1 and 3 shall not apply.
(4) paragraph 1 sentence 2 number 5 is not applied on 1 storage rooms, exclusively supplying medicines from hospitals or to the care of residents of institutions to be supplied within the meaning of section 12a of the pharmacy Act serve, 2 rooms, mail order including the electronic trade in medicines, as well as the related advice and information concerning, 3 rooms which are used for the production activities referred to in section 34 or 35 § , or 4 the night duty room.
However, these spaces must be in reasonable proximity to the other premises. The use of storage or production areas within the hospital to be supplied or the equipment to be supplied within the meaning of section 12a of the pharmacy Act is not allowed.
(5) (dropped out) display (6) significant changes in the size and location, or the equipment of the premises or their use is before the competent authority.
(7) the pharmacy must be equipped with devices that medicines especially in the dosage forms 1 suppositories and ovules properly can be produced solutions, emulsions, suspensions, 2. ointments, creams, gels, pastes, 3 capsules, powder, 4 drug compounds and 5. The production of sterile pharmaceutical products must be possible unless it is drug for parenteral use. As far as there is no unit for the production of water for injection, water must be kept for injection as a finished product in sufficient quantities in stock.
(8) in the pharmacy equipment and test equipment for testing of pharmaceutical products manufactured in the Pharmacy and its precursors must exist according to the pharmaceutical standards.
Section 4a of Pharmacy leaders hygiene measures must meet appropriate hygiene measures for the staff and the premises used for the production of medicines, ensure the microbiological quality of the respective medicinal. For the hygiene measures in particular is to determine: 1 the frequency and type of cleaning the production areas or production rooms, 2. If necessary, the frequency of a disinfection of the production areas and production rooms and 3 to be deployed systems and equipment.
The measures are to be set in a hygiene plan in writing. The implementation of hygiene measures must be documented regularly. Specifications of hygienic behavior in the workplace, and to the protective clothing of the personnel shall be taken without prejudice to the hygiene plan.
§ 5 scientific and other AIDS in the pharmacy must there be 1 scientific tools that are necessary for the manufacture and testing of medicinal products and raw materials for the pharmaceutical standards of Pharmacy operation, in particular the Pharmacopoeia, 2 scientific tools that are necessary for information and advice on medicinal, 3. scientific tools for providing information and advice to the practice of medicine , Dentistry or veterinary medicine entitled persons regarding medicinal products are required, 4. texts of legislation relevant to the operation of the pharmacy.
The scientific and other tools to keep up to date and may be present on electronic data carriers.
§ 6 have general rules on the production and testing of must (1) medicinal products which are manufactured in the pharmacy, the quality required for pharmaceutical science. You are to make the pharmaceutical standards and check; the pharmacopoeia contains appropriate rules are to manufacture medicinal products according to these rules and to examine. It can be applied other methods for testing and other devices used, than those described in the German pharmacopoeia under the condition to achieve the same results as with the described methods and devices. The test is if necessary, within reasonable periods to repeat.
(2) in the case of the manufacture of medicinal products, precaution shall be taken to avoid adverse interference of drugs and mix-ups of medicines and the raw materials and of packaging and labelling material.
(3) the examination of pharmaceutical products can be done under the responsibility of the pharmacy manager outside the Pharmacy: 1 in an operation for which a permit according to § 13 of the German medicines Act is, 2nd in a holding in a Member State of the European Union or the European economic area, for the respective national law a permit in accordance with article 40 of Directive 2001/83/EC of the European Parliament and of the Council of the 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311 of 28.11.2001, p. 67), as last amended by the directive of 2011/62/EC (OJ L 174 of the 1.7.2011, p. 74), in its up-to-date version or a permit pursuant to article 44 of Directive 2001/82/EC of the European Parliament and of the Council of the 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311 of 28.11.2001, p. 1), as last amended by Regulation (EC) no 596 / 2009 (OJ L 188 of the astronomy, p. 14), granted in the currently valid version is 3rd in an operation for which a permit according to § 1 paragraph 2 in conjunction with section 2 of the pharmacy Act is issued, or 4th by an expert within the meaning of section 65 paragraph 4 of the medicines Act.
He for the exam has responsible of the establishment or the person pursuant to sentence 1 number 4 stating the charge and the date and the results of the test to certify that the medicinal product has been tested according to the recognised pharmaceutical rules and having quality required (test certificate). The results from the inspection certificate are to be sharing in the pharmacy based. In the Pharmacy at least the identity of the medicinal product should be noted; There are records to make about the tests.
(4) the law of medical product manufacturing, custom and in-house production of medical devices shall remain unaffected.
§ 7 recipe medicines (1) is a medicinal product on the basis of a prescription from people, that to practice medicine, dentistry or veterinary medicine entitled are manufactured, it must match the prescription. Others are not allowed as the starting materials referred to in the notes without the consent of the prescribing in the production. This does not apply for raw materials, as long as they have no own medicinal effect and does not adversely affect the medicinal effect. A prescription contains a noticeable error it is illegible or other concerns arise so the medicines must not be made, before the uncertainty was removed. Sentence 4 according to apply to is in single production without a prescription.
(1a) a medicinal product formula is to produce according to a pre-established written production, which is to sign a pharmacist or in the representation according to § 2 paragraph 6 of the person authorised to represent the pharmacy. The production statement must be at least specifications meet 1 establishing the respective pharmaceutical form including the manufacturing technique and the equipment, 2nd to the plausibility checks referred to in paragraph 1B, 3. the labeling and primary packaging materials, 4th to in-process controls, as far as these are feasible, 5. preparation of the workplace as well as 6 to release and documentation.
Insofar as third parties to standardized and general preparation instructions, they are to adjust to the respective pharmacy operation.
(1B) that is requirement for the manufacture of a medicinal product formula to assess (plausibility check) from a pharmacist after pharmaceutical point of view. The validation must take into account in particular the following: 1 the dosage, 2. the method, 3. the type, quantity and compatibility of the raw materials with each other and their consistent quality in the finished recipe medicines over the durability period and 4. the shelf life of the medicinal product formula.
The validation shall be documented by a pharmacist or in the representation according to § 2 paragraph 6 of the person authorised to represent.
(1c) that is making the recipe medicines to document (making Protocol) from the manufacturing person and must include in particular the following: 1. the type and quantity of precursors and their batch names or test numbers, 2. the parameters of production, 3. as far as in-process controls are provided, their result, 4. the names of the patients and the prescribing physician or dentist, 5. medicines used in animals the name of the keeper and the animal species, as well as the name of the prescribing veterinarian , 6th of recipe medicines manufactured on customer request, the name of the customer as well as 7 the name of the person who has made the recipe medicines.
Instead of the name of the patient, keeper or customers pursuant to sentence 1 number 4, 5 or 6 can be documented a growing reference manufacturing number. The production Protocol is to supplement that made drug corresponds to the requested recipe drugs (release) from a pharmacist or in the representation according to § 2 paragraph 6 of the person authorised to represent with the result of the organoleptic assessment made for the release and its confirmation. The release must be made before delivery to the patient.
(2) when a recipe medicines may be waived by an analytical examination, provided that the quality of the medicinal product by the production process, the organoleptic testing of the finished medicinal product and, if provided, is warranted by the results of in-process controls.
§ 8 defective pharmaceutical products (1) is a medicinal product defect to produce according to a pre-established written production, which is to sign by a pharmacist of the pharmacy. The manufacturing instruction must meet particular specifications: 1 to the to be used raw materials, primary packaging materials and the equipment, 2. the technical and organisational measures to avoid cross contamination and mix-ups, including preparation of the workplace, 3. laying down the steps, including the setpoints, and as far as practicable, of in-process controls, 4. for identification, including date of manufacture and the date of expiry or review , and, if necessary, storage conditions and precautions as well as 5 to release to the placing on the market within the meaning of article 4, paragraph 17 of the medicines Act.
(2) the production is in accordance with the statement of production at the time of the production of the manufacturing person (making Protocol); from the content of the Protocol, all major activities relating to the manufacture must allow track. The production log must call the underlying production statement and include in particular the following: 1 the production date and batch number, 2. the used raw materials, as well as their samples or dimensions and their batch names or test numbers, 3. the results of in-process controls, 4. the production parameters, 5. the overall yield and, if applicable, the number of separate dosage forms, 6 expiration date or the date of the subsequent test and 7 the signature of the person , which has manufactured the drug.
The production Protocol is to supplement that manufactured medicinal products the manufacturing instructions conform to (release) from a pharmacist with his confirmation.
(3) for the inspection of defective pharmaceutical products is to make a test statement that is signed by a pharmacist of the pharmacy. The testing procedure must include at least information to sampling, the test method and the way the exams including the allowable set or limits.
(4) the audit is performed in accordance with the test instructions pursuant to paragraph 3 and to document, which carried out the test (test report) by the person. The test report must mention the underlying inspection instruction and in particular contain 1 to the date of the inspection, 2 to the test results and their approval by the responsible pharmacist who has carried out the inspection or supervision.
articles 9 & 10 (dropped out) - section 11 precursors (1) only to the manufacture of medicinal raw materials used, the proper quality of which has been established. On the testing of raw materials, the provisions of § 6 find outlets 1 and 3 apply.
(2) raw materials are involved, the quality of which is established pursuant to section 6 para 3 by a test certificate, is in the Pharmacy at least the identity to determine. The test certificate should also provide information about the GMP compliant production of the starting material, insofar as it is an active ingredient. The responsibility of for pharmacy managers for the proper quality of starting materials shall remain unaffected. About the tests performed in the pharmacy records with name character of pharmacist examiners or supervised the examination must be made.
(3) medicinal products which are not finished medicines, related to the production of other pharmaceutical products, apply according to paragraphs 1 and 2.
§ 11a activities on behalf of (1) as far as the pharmacy manufacturing of medicinal products in accordance with article 21, paragraph 2 number 1 b of the medicines Act or section 11, paragraph 3 or 4 of the pharmacy Act, other companies may undergo a written contract between the pharmacy as a client and the other operating as a contractor must be for this, which must be present in both companies. The responsibilities of each side are clearly set in the Treaty. Sentence 1 applies provided raw materials for the testing of medicinal products manufactured in the Pharmacy and the checking in the pharmacy to drug manufacturing, as far as it goes beyond the identity verification.
(2) the head of the pharmacy a drug manufacturing must only be in order if exists him a prescription for the medicinal product concerned and no concerns arose after examining the regulation. § 7 shall apply accordingly. The responsibility for the quality of the manufactured medicinal as well as for the information and guidance of the prescribing physician will remain with the pharmacy as a principal.
§ 12 testing of the finished medicinal products produced not in the Pharmacy and pharmacy-only medicine products are (1) finished pharmaceutical products which are not produced in the Pharmacy at random to check. It must to be aside from scrutiny beyond the sense test, no evidence showed, justify the doubt of the proper quality of the medicinal product. Sentences 1 and 2 apply to pharmacy medicine products according to.
(2) to pass certificate of inspection must at least include 1 the name or the company of the marketing authorisation, for medical devices of the manufacturer or his authorised representative, 2. the label and medicines in addition to the dosage form, 3. the lot number or date of manufacture, 4. the date and the results of the test, 5. pharmacist supervised the name character of the testing or examination.
§ 13 containers may used only primary packaging materials for the production of medicinal products, which ensure that the medicinal products against physical, microbiological or chemical changes are protected and which are suitable for the intended purposes.
§ 14 labelling must (1) recipe medicines on the containers and, where used, the outer packages, have at least the following information: 1. name and address of the Pharmacy and, as far as different, of the manufacturer, 2. content by weight, volume or number, 3. type of application, instructions for use 4, 5. active substances after other components according to the type and amount, 6 date of manufacture, 7 availability period with the note "use by", stating the day , Month and year and, to the extent necessary, indication of durability as far as the recipe medicines on the basis of a prescription for use in people produced notes on special precautions, for storage or for the disposal of unused medicinal products or other special precautions in order to avoid, the risks for the environment and 9 after the opening of the container, or after production of the ready-made preparation, 8 where necessary, , The patient's name.
The particulars must be attached well legible and permanent manner and written with the exception of the number 5 in the German language. Where a finished product is used as a raw material for the formulation of medicinal, the indication of the designation is sufficient instead of stating after number 5 of the finished product. The information can be provided in an accompanying document referred to in point 8.
(1a) insofar as the medicinal subsets taken from finished product, are in addition to the labelling required by the medicines Act to specify name and address of the pharmacy.
(1B) for the labelling of drugs intended for clinical testing on humans, is to apply section 5 of the GCP regulation.
(2) on defective medicines, which are kept in stock as a finished product in a package destined for delivery to the consumer and 1.
Medicinal products within the meaning of article 2, paragraph 1 or paragraph 2 are number 1 of the medicinal products Act and are intended not for clinical trials on humans or 2. medicinal products within the meaning of article 2, paragraph 2 are number 2, 3 or 4 of the medicines Act, is to apply sec. 10 of the German medicines Act. As far as them an approval is not required for number 1 or a registration pursuant to article 21, paragraph 2 according to § 38 paragraph 1 sentence 3 of the German medicines Act, the indication of the admissions or registration number required. B of the German medicines Act may be waived by the information according to § 10 paragraph 1.
(3) medicines produced in the pharmacy that does not finished medicinal and intended for use in animals which serve the production of food, may be brought only in the traffic, if the containers and, where used, are the outer wrappings with the data according to §§ 10 and 11 of the medicines Act.
(5) (lapsed) § 15 stock-holding (1) the head of the Pharmacy has the drug and pharmacy-only medicine products, which are necessary to ensure a proper supply of medicines in the population, to keep that corresponds to at least the average requirement for a week in a lot in stock. In addition shall be kept in the pharmacy in stock: 1. analgesics, 2. narcotic drugs, including opioids for injection and oral immediate release and modified release, 3. Glucocorticosteroide injection, 4. antihistamines for injection, 5. glucocorticoids inhalation for the treatment of flue gas intoxication, 6 Antifoam agent for the treatment of surfactant intoxication, 7 medical coal, 50 grams powder for oral suspension, 8 tetanus vaccine , 9 tetanus-hyper immunoglobulin 250 I. E., 10 epinephrine injection, 11 0.9% saline, solution for injection, 12 dressings, disposable syringes and needles, catheters, transfer devices for infusions, as well as products for determining blood sugar.
(2) the pharmacy manager must ensure that the medicinal products with the following ingredients are kept in stock in the pharmacy or can be obtained in the short term: 1. botulism antitoxin of the horse, 2. diphtheria antitoxin from the horse, 3. venom immune serum, polyvalent, Europe, 4. rabies vaccine, 5. rabies immune globulin, 6 varicella-zoster immune globulin, 7 C1 esterase inhibitor, 8 hepatitis B immune globulin, 9 hepatitis-B vaccine, 10 Digitalis antitoxin, 11 opioids in trans-dermal and transmucosaler dosage form.
(3) the head of a hospital serving pharmacy need the medicines necessary to ensure a proper supply of medicines the patients of the hospital, and, as far as according to the supply agreement provided medical devices in a type and quantity in stock keep, corresponding to at least the average requirement for two weeks. These medicinal products and medical devices are to enumerate.
§ 16 storage (1) medicines, raw materials, medical products and common pharmacy goods and test equipment are clear and so stored, that their quality is not adversely affected, and confusion be avoided. As far as their proper quality is not detected, they are under appropriate identification to separately store. The same applies to containers, outer casings, marking material, leaflets and packaging materials. Prejudice to the provisions of Ordinance on hazardous substances as well as the narcotic drugs and the medical devices act, including the regulations for this purpose. The storage of the pharmacopoeia should be noted.
(2) the storage containers for medicines and raw materials must be such that the quality of the content is not affected. You must be accompanied by legible and permanent signs which uniquely identify the content. This is a common scientific name to use. The content is to identify, as far as this is necessary for establishing the quality and to avoid confusion with additional information. The expiration date or, if necessary, a verification date shall be indicated on the containers.
(3) (lapsed) (4) (dropped out) § 17 purchase and dispensing of medicinal products and medical devices (1) medicines may be acquired only by companies entitled to the dispensing of medicinal.
(1a) medicines may be brought in the case of section 11a of the pharmacy Act and of paragraph 2a, in the pharmacy operating room only in the traffic and handed out by pharmaceutical personnel only. Sentence 1 is to use pharmacy medicine products according to.
(2) delivery by messengers of the pharmacy is in the individual case without permission according to § 11a of the pharmacy Act There are separate to pack the drugs for each recipient and to provide each with its name and address. Paragraph 2a sentence 1 No. 1 and 2 and sentence 2 shall apply accordingly; Paragraph 2a sentence is 1 No. 5 to 7 and 9, if necessary, also to apply. Delivery by Messenger to take care is that the drug provided the recipients in a reliable manner. If a consultation at the Pharmacy was not already made, advice must be by the pharmaceutical personnel of the pharmacy directly related to the delivery. Prejudice to the provisions of § 43 5 of the medicines Act on the dispensing of medicinal products which are intended for use in animals.
(2a) where according to § 11a of the pharmacy Act allowed shipping has the pharmacy manager to ensure that 1 so the drug packed, transported and delivered, that its quality and efficacy is maintained, 2. delivered the medicines according to the instructions of the principal and, where appropriate, the delivery in writing. The pharmacist may in justified cases contrary to the specification of the customer, in particular because the nature of the medicinal product have, that the medicinal product only against written receipt is delivered, 3. the Orderer in a suitable manner of them will be informed if it is apparent that the sending of ordered medicinal within period referred to a no. 3 letter a of the pharmacy Act can be made in section 11, 4. any medicinal product ordered , may be brought within the scope of the German medicines Act in the traffic and are available to be delivered, 5. in case of known risks from medicinal ways to report such risks available are the customers, informs the customer about him concerned risks and internal defensive measures are carried out to ward off risks of medicinal products, 6 the treated person is pointed out , that she with the treating doctor or the doctor should contact, experiencing problems with the use of the medicinal product, 7 the treated person pointed out is that she as a prerequisite for the drug delivery with your order to specify a phone number has, under the pharmaceutical personnel of the pharmacy with authorization to dispatch were medicinal products in accordance with Article 11a of the pharmacy Act, also using the facilities of telecommunications without additional fees; advising the ways and times of consultation shall be communicated to them, 8 a free second delivery causes and 9 maintained a system for tracking.
The dispatch must not take place when the safe use of the medicinal product an information or need advice, which can be drawn in a different way as a personal information or advice of a pharmacist.
(2B) for medicinal products containing the active substances Pomalidomid, Lenalidomide and thalidomide, and admitted to the emergency contraception drug with active ingredient levonorgestrel or ulipristal acetate, a placing in the way of shipment is not allowed according to § 43 para 1 sentence 1 of the German medicines Act.
(3) the head of the pharmacy may not bring medicines and medical devices, which are subject to pharmacy, through self service on the market.
(4) securities issued by persons who are entitled to the exercise of medicine, dentistry or veterinary medicine, are run in a time-appropriate prescribing.
(5) the dispensed medicines must comply with the prescriptions and associated provisions of the fifth book of social security code to the supply of medicines. A prescription contains an error recognizable for the issuing, it is not readable or other concerns arise as the medicines may not be placed, before the uncertainty was removed. The pharmacist has to note any change on the prescription and to sign or to add in the case of the bond issued in electronic form of electronic prescribing and to provide the complete document with a qualified electronic signature according to the signature law. The provisions of the narcotic prescription Regulation shall remain unaffected.
(5a) by way of derogation from paragraph 5 sentence 1 may the pharmacist service call times according to § 23 paragraph 1 sentence 2 another one with the prescribed medicines according to application area and type and quantity of the active ingredients give identical and comparable dosage form and pharmaceutical quality medicinal, if the prescribed drugs is not available while an urgent case is , which requires the immediate use of the medicinal product.
(6) in the case of the supply of the medicinal name or company of the owner of the pharmacy, and whose address, 2 are on the prescription and if it add 1 to a prescription according to § 3a paragraph 1 sentence 1 dealing in drug prescription prescription, on the copy of the prescription, to specify, or in the case of the bond issued in electronic form of electronic prescribing the name character of pharmacist , the pharmacist, the pharmacy engineering or pharmacy wizards, which submitted the drug or pharmacist, who has supervised the delivery in case the prescription electronically the name character by an electronic signature is the signature Act to replace that where the pharmacy manager to ensure the traceability of the respective signatory and whose documentation has, 3. the date of submission, 4. the price of the medicinal product, 5 in article 300 para. 3 No. 1 of the fifth book of the social code called Federal flag for the given medicinal , as far as it is intended for use in humans.
By way of derogation from number 2 the pharmacy manager onto the power to sign-off of securities pursuant to § 3 para 5 pharmaceutical technical assistant. The pharmaceutical technical assistant has in the cases of paragraph 5 sentence 2 and in the notes which do not remain in the pharmacy, prescription prior to immediately submit a pharmacist after the donation of medicines in all other cases.
(6a) the purchase or distribution of blood preparations, Sera from human blood and preparations from other substances are origin, as well as genetically manufactured plasma proteins for treating hemostasis disorders human to record the following information for the purpose of tracing: 1 the name of the medicinal product, 2. the batch number and the quantity of the medicinal product, 3. the date of the acquisition and the tax, 4. name and address of the prescribing doctor as well as name or company and address of the supplier and 5 name , First name, date of birth and address of the patient or of for the doctor's Office the name and address of the prescribing physician specific tax.
(6B) in the acquisition and distribution of medicinal products with the active ingredients of Lenalidomide, Pomalidomid or thalidomide and the acquisition of these ingredients are to record the following information: 1 the name and the batch name of the medicinal product or the active substance, 2. the quantity of the medicinal product or the active substance, 3. the date of purchase, 4. the date of submission, 5. name or business name and the address of the supplier , 6 name and address of the prescribing doctor or the prescribing physician's and 7. name and address of the person for which the medicinal product is intended.
After the dispatch of the copies of the forms according to § 3a paragraph 7 of medicinal prescription regulation at the Federal Institute for drugs and medicine products, the date of sending is to add the information pursuant to sentence 1.
(6c) pharmacies may take no medicines from other pharmacies. Sentence 1 is applied to medicines, 1 you be involved according to § 52a paragraph 7 of the German medicines Act in the usual pharmacy operation of pharmacies, 2. the obtained from pharmacies, for the same permit has been issued pursuant to section 1 paragraph 2 in conjunction with § 2 paragraph 4 of the pharmacy Act, 3 which may be obtained from pharmacies in accordance with article 11, paragraph 3 or 4 of the pharmacy Act , 4 which are propagated after closure of a pharmacy to a subsequent licence holder under the pharmacy Act or 5. related in urgent cases by a pharmacy an urgent case is if the immediate application of the product is required, and if the drug can be obtained in a timely manner or manufactured.
Medicinal products by pharmacies are involved or of these passed on to other pharmacies, the batch name of the respective medicinal must in addition be documented and communicated to the receiver also.
(7) as far as public pharmacies to supply hospitals with medicines, the rules of § 31 para 1 to 3 as well as article 32 according to. Sentence 1 applies to pharmacy medicine products according to.
(8) the pharmaceutical personnel has to confront an identifiable drug abuse in an appropriate manner. In case of justified suspicion of abuse, the tax is to refuse.
§ 18 medicinal importation of medicinal products (1) according to § 73 Absatz 3 or 3a of the medicinal products act within the scope of this regulation are spent, following record 1 the name of the imported medicinal product, 2. the name or business name and address of the marketing authorisation, 3. the batch number, amount of the drug and the dosage form, 4. the name or business name and the address of the supplier , 5. the name and address of the person for which the medicinal product is intended, 6 the name and address of the prescribing physician or of the prescribing veterinarian, 7 the date of ordering and the levy, 8 which has cast the medicinal name character of the pharmacist, or supervised the delivery. Unless special instructions are offered for reasons of safety, these are telling in giving. This communication shall be recorded.
(2) finished product, also transferred from a Member State of the European communities concerning the scope of section 73, paragraph 3 of the German medicines Act in the scope of this regulation, are allowed only for the first time by a pharmacy in the traffic, when they are tested according to § 6 paragraph 3 sentence 1 to 3 and the required quality is confirmed. The examination can seen if the medicinal products in the Member State are tested according to the applicable legislation and documents corresponds to the test protocol are available.
Acquisition and delivery of prescription veterinary medicines (1) over the acquisition and distribution of prescription medicines, which are intended for use in animals are article 19 to temporally ordered evidence. When sufficient proof is to look at: 1. for acquiring the overall compilation of delivery notes, invoices, or Warenbegleitscheine, from which derived: a) name or business name and address of the supplier, b) name and quantity of the medicinal product including its batch number, c) the date of the purchase;
2. for providing a double or an illumination of the prescription with records of a) name and address of the consignee, b) name and address of the prescribing veterinarian, c) name and quantity of the medicinal product including its batch number, d) the date of delivery.
As far as according to § 4 section 2 of the drug prescription prescription prescription not in written or electronic form is submitted, the values are 2 No. 2, also in connection with sentence 4, distribution pursuant to sentence document. As far as in the cases of sentence 2 No. 1 letter c the medicinal product not in batches on the market is placed (b) and no. 2 and carries a date of manufacture is to specify this.
(2) prescription drugs intended for use in animals, the aim of gaining food, may be placed only on a prescription which will be submitted in two copies. The original of the prescription is intended for the pet owner, the copy remains in the pharmacy. On the original, the batch number of the drug must be given; If it is not brought in batches on the market and bears a date of manufacture, this shall be indicated.
(3) the head of the Pharmacy has to calculate the inputs and outputs of prescription medicines intended for use in animals against the existing stock of these drugs at least once a year and to detect deviations.
Article 20 information and advice (1) the head of the pharmacy must ensure within the framework of the quality management system informed and advised of patients and other customers, as well as persons entitled to practice medicine, dentistry or veterinary medicine sufficiently about medicines and pharmacy medicine products. The obligation of information and advice on medicinal products must be applied by a pharmacist of the pharmacy, she can be adopted by other members of the pharmaceutical personnel of the pharmacy, if the pharmacy manager has prior written set this. While he has to define cases in which a pharmacist of the pharmacy in principle be consulted is also.
(1a) through the information and counselling of patients and other customers must not be impaired the treatment of the persons entitled to practice medicine, dentistry or veterinary medicine. As far as medicines without a prescription are delivered, the pharmacist has to give information required for the proper application of the patients and other customers.
(2) in particular aspects of drug safety must be considered in providing information and advice on medicinal products. Advice must include the necessary information about the proper use of the medicinal product, where necessary, also about possible side effects or interactions resulting from the information on the prescription, as well as the information of the patients or customers, and the proper storage or disposal of the medicinal product. Distribution of medicines to a patient or other customers is also to determine by demand, to offer appropriate advice to what extent this, where appropriate, further information and advice has and a. In the case of self medication is also to determine whether the desired medicinal product for use in the intended person seems suitable or recommended is cases in which, if necessary, consult a doctor. Sentences 1 to 4 apply to pharmacy medicine products according to.
(3) the head of the pharmacy must provide relevant information to help patients and other customers to make an informed decision, also as regards treatment options, availability, quality and safety of the services provided by him; He provides further clear invoices and clear pricing information as well as information about the permission or approval status of the pharmacy, insurance coverage or other forms of personal or collective protection in relation to its professional liability.
(4) the head of a hospital serving pharmacy or a pharmacist authorised by him is the information and consultation of doctors of hospital medicines and pharmacy medicine products. He is a member of the drug Commission of the hospital.
§ 21 drug risks, treatment of not capable to transport medicines of the pharmacy manager has to ensure that the following measures be taken drug risks and ineligible traffic drugs: 1. all information about complaints of medicinal products, in particular about drug risks, such as quality and packaging defects, defects labelling and package leaflet, side effects, interactions with other drugs are contra-indications and misuse immediately inform him or a pharmacist authorised by him.
2. he or the pharmacist appointed by him has to verify the information and to initiate the necessary measures for security.
3. is on drugs or precursors, which moved into the pharmacy, which assumption is justified that exists for quality defects, which are caused by the manufacturer, must immediately notify the competent authority.
4. If you recall of medicinal products which have been manufactured in the pharmacy, the competent authority stating the reason to inform immediately.
5. about drug risks, provided in the pharmacy, and the affiliated prompted checks, measures and notifications are records to make.
6. when supplying hospital pharmacies he has known him without prejudice to the numbers 1 to 5 growing drug risks inform the senior doctors and the drug Commission of the hospital.
7 medicines or raw materials which are not marketable or a prompt to return, are to fashion, to return or destroy; If they are not immediately reworked, returned or destroyed, they are as such recognisable to make and secrete. There are records to make the measures.
8 counterfeit medicines which are found in the distribution network are separated until a decision on the way forward of traffic-enabled medicinal and secured to keep, to avoid confusion and to prevent unauthorized access. You must clearly not to sell certain drugs be marked as. The competent authority is to inform immediately on the occurrence of counterfeit medicines. The measures taken must be documented.
The medical security plan regulation applies to medical devices.
Article 22 General documentation (1) all records of the manufacture, testing, review of medicines in the hospital and to be supplied facilities within the meaning of section 12a of the pharmacy Act, storage, import, placing on the market, the callback, the return of medicines on the basis of a recall, the certificates according to article 6, paragraph 3, sentence 2 and article 11, paragraph 2, sentence 1 and the evidence according to § 19 are fully and at least until one year after the expiration date , but not less than five years, to be kept. The initial contents of the registration must not be defaced. No changes must be made, not that indicate whether they have been made during or after the original registration.
(1a) (1B) records according to article 17, paragraph 6, sentence 1 No. 2 are (dropped out) half-sentence 2 after the last entry for three years to be kept.
(2) records can be made also on image or data carriers and stored. This ensures that the data available during the retention period and can be made readable within a reasonable period of time?, A recording and storage only on disks is a name character required under this regulation through an electronic signature to the signature law and a handwritten signature by a qualified electronic signature according to the signature law to replace.
(3) the records and documents shall be provided to the competent authority upon request.
(4) by way of derogation from paragraph 1 the records are according to § 17 para 6a to keep at least thirty years to save and destroy or delete, if the storage or storage is no longer necessary. The records are kept longer than thirty years or stored, they are anonymous.
Article 23 service readiness (1) pharmacies are committed to the continuous service readiness. The competent authority free from the obligation of service a part of the pharmacies wholly or partly at the following times: 1st Mondays to Saturdays from 0:00 A.m. until 8:00, 2nd Monday to Friday from 18:30 to 24:00, 3rd Saturday from 14:00 until 24:00, 4th on the 24th and 31st of December from 14:00 until 24:00, 5th Sundays and public holidays.
(2) the obligation of service can the competent authority for the duration of the local closing times, apprenticeship, Saturdays or the Annual closing and, if there is a legitimate reason, free outside these times, when the drug supply is guaranteed during this time by a different pharmacy, which may reside in another community,.
(3) during the periods referred to in paragraph 1 sentence 2 it enough to guarantee of the service for is the pharmacy manager or authorized person in close proximity to the pharmacy operating room and accessible at any time. The competent authority can in well-founded exceptional cases a pharmacy manager at the request from the obligation pursuant to sentence 1 free, if the pharmacy manager or an authorized person at any time accessible and ensure the supply of medicines in a manner reasonable to the customer.
(5) a clear note on the nearest in-service pharmacies is to install to not in-service pharmacies for patients or other customers at a clearly visible point.
(6) pharmacies that supply hospitals with medicines and pharmacy-only medicine products, have to make service arrangements that ensure the proper supply of medicines in the hospital and counselling by a pharmacist of the pharmacy without prejudice to the provisions of paragraphs 1 to 4 with the support of the hospital.
§ 24 recipe collection (1) facilities to collect prescriptions (recipe collection) may be entertained only with the permission of the competent authority. The permission is to grant the holder of a pharmacy at the request if a recipe collection is necessary to the proper drug supply from remote places or local parts without pharmacies. The permission is limited in time and must not exceed a period of three years. A repeated issue is allowed.
(2) recipe collection points must be entertained not in businesses or professionals.
(3) the securities must be collected in a sealed container is protected from access by unauthorized persons. On the container, the name and address of the Pharmacy and pick-up times must be clearly specified. A clear indication is also on or immediately adjacent to the container to attach that prescription with name, first name, place of residence, street and house number of the recipient and indicating whether the order in the pharmacy to be picked up or delivered to the recipient, is fitted. The container must be emptied at the times specified on him by a Messenger who must belong to the staff of the pharmacy, or picked up.
(4) the medicinal products are be packaged separately in the pharmacy for each recipient and to provide each with its name and address. They are if they are not picked to deliver the recipient in a reliable manner in the ways of the Messenger delivery pursuant to article 17, paragraph 2.
§ 25 (dropped out) - § 25a defense-threatening communicable diseases
In case of a threatening communicable disease, whose spreading significantly higher deployment of specific medicinal products requires an immediate and the usual amount, section 11 subsection 2 does not apply to raw materials no. 1 c of the German medicines Act used for the manufacture of medicinal products within the meaning of § 21 para 2, unless 1 the quality of which is demonstrated according to § 6 paragraph 3, by a test certificate 2. the container is so locked , that an interim opening of container would be visible and 3. neither the container nor the CAP are damaged.
If the container by a firm in a Member State of the European Union or the European economic area, the according to respective national law over a permit pursuant to article 77 of the Directive 2001/83/EC was has opened for the purpose of filling around or packing of the raw material in unaltered form, section 11 subsection 2 is then no application if a copy of the certificate of inspection according to § 6 ABS. 3, as well as a written confirmation of the operation of the Pharmacy , that when opening the vessel the conditions templates 1 No. 1 to 3 to set and the starting materials in suitable containers were transferred to or packaged. A-threatening communicable disease, their spreading makes required significantly greater than an immediate and the usual measure deployment of specific medicines, applied article 17 paragraph 1 not for medicinal products, which are made available by the competent authorities of the Federation or of the countries.
Third section of operation of hospital pharmacies section 26 applicable provisions (1) the hospital pharmacy is the functional unit of a hospital, ensuring the proper supply of one or more hospitals with medicines and pharmacy-only medicine products as well as the information and advice about these products, particularly from doctors, nurses and patients, is whether the.
(2) the regulations sections 1a and 2a as well as the sections 4a, 5 to 8 and 11 to 14, 16, 17 (1) and 6 c, the §§ 18, 20 shall apply paragraph 1 and of articles 21, 22 and 25a for the operation of hospital pharmacies.
§ 27 head of hospital pharmacy (1) pharmacy manager is the pharmacist employed by the institution of the hospital and entrusted with the leadership.
(2) the head of the hospital pharmacy is responsible for ensuring that the pharmacy in accordance with the applicable regulations is operated. He has in particular to ensure that 1 the ordered drug and pharmacy-only medicine products as needed provided and made immediately available to medicinal products which are needed particularly urgent, acute care, 2. regularly check the medicines stored in the hospital and pharmacy-only medicine products and the checks are documented, 3. a pharmacist of the pharmacy a) the staff of the hospital in regard to a safe , functional and economical drug therapy and application of medicines or nonprescription medicine products and b) where necessary, advises the patients in regard to a safe use of medicines, in particular in connection with his release from the hospital.
The head of the hospital pharmacy is a member of the drug Commission of the hospital.
(3) the Director of the hospital pharmacy may be represented only by a pharmacist. This has the duties of the pharmacy manager during the duration of the representation.
(4) the provisions of § 2 para 3 and 5 shall apply mutatis mutandis.
§ 28 staff of the hospital pharmacy (1) that necessary staff, including the pharmaceutical personnel needs for a correct operation of the hospital pharmacy must be available in sufficient numbers. Personnel requirements arises from nature and scope a medically appropriate and sufficient supply of hospital medicines and nonprescription medicinal products, taking into account the size, type and power structure of the hospital. Sentence 2 shall apply accordingly if the hospital pharmacy provides other hospitals.
(2) for the use of the Pharmacy staff, the head of the hospital pharmacy is responsible.
(3) the provisions of article 3, paragraph 1, 5 and 6 shall apply mutatis mutandis.
§ 29 rooms and establishment of hospital pharmacy (1) which required compartments must provide a proper operation of the hospital pharmacy be present. This type, quality, size and number of rooms and the establishment are the establishing hospital pharmacy at the scales of the § 28 para 1 sentence 2.
(2) the hospital pharmacy shall consist at least of an Office, two laboratories, a business room and an adjoining room and must have sufficient storage space; an extractor vent must be located in a laboratory. A storage below a temperature of 25 degrees Celsius must be possible. The footprint of the operating rooms must be at least 200 square metres. Set of 4, paragraph 2 b, 2 c, 2d, 4 sentence 3 and paragraph 6 shall apply the provisions of § 4 paragraph 1 sentence 1, 2 number 1 to 4, sentence 3, paragraph 2.
(3) type and number of devices to the manufacture, testing and determination of source materials and medicines as well as type and number of test equipment in size, have to align nature and power structure of the hospital. The provisions of § 4 paragraph 7 and 8 shall apply.
§ 30 stockpiling in the hospital pharmacy the medicines necessary to ensure a proper supply of the patients of the hospital and pharmacy-only medicine products must be kept in stock in sufficient amount, which must comply with at least the average requirement for two weeks. These medicines and pharmacy-only medicine products are to enumerate.
Article 31 duty in the hospital pharmacy (1) medicines and pharmacy medical devices may be placed at stations or other units of the hospital only on the basis of a prescription in individual cases or on the basis of a written request. This also applies for prescriptions or requests in electronic form.
(2) in the case of delivery to stations and other units of the hospital, the pharmaceuticals and pharmacy-only medicine products from access are to protect from unauthorised use. You are to give in a suitable locked container, at the Pharmacy and the recipient to be. Subsets of finished pharmaceutical products, which should be handed out to patients in connection with a forward or after in-patient treatment or out-patient Surgery apply outside of the hospital, are in accordance with § 14 para 1 sentence 2 to identify and to provide with a leaflet.
(3) medicinal products out for sale to the consumer certain packages may only be submitted without outer packaging are, if on the container the name of the medicinal product, the batch number and, as far as prescribed for the medicinal product, added to expiry date and storage instructions are given and the package leaflet.
(4) the provisions of § 17 paragraph 1, 1a, 4, 5, 6 sentence 1 number 1 to 3 and set 2 and 3 and paragraph 6a to 6c shall apply mutatis mutandis.
§ 32 review of medicinal supplies and nonprescription medicine products on the stations (1) the commitment of the head of the hospital pharmacy or a pharmacist authorised by him the pharmacy to review the drug inventories according to § 14 para 6 of the Pharmacy law extends on all the stations and in other units of the hospital in stock held medicinal; the review of drug supplies must be done at least every six months. Sentence 1 applies accordingly to pharmacy medicine products.
(2) the examining pharmacists and pharmacy staff supporting him are entitled to enter the premises, which serve the drug supply. The hospital management and other hospital staff have to support the implementation of the review.
(3) the head of the hospital pharmacy or pharmacy pharmacist appointed by him has to make a protocol in four copies on each review. The Protocol must at least contain the date of the inspection, 2. 1 the name of the station or of another unit of the hospital, 3. the name of the pharmacist and the others in the review involved persons, 4. the nature and scope of the review, particularly with regard to a) General storage and storage conditions, b) the storage and preservation of medicinal products and medical devices after the pharmaceutical standards , c) of nature including the labelling of medicinal products and medical devices, d) the expiration dates, 5. the deficiencies, 6 the measures led to the removal of defects, 7 the deadline for the Elimination of deficiencies, 8 information on the disposal of previously determined deficiencies, 9 the signature date of the pharmacist responsible for the review.
A copy of the Protocol is the hospital management at the latest four weeks to send serious defects immediately after conducting the review, each one more is handed over to the doctor, as well as the nursing service management, which is responsible for the supply of medicines, the station or the other unit of the hospital, and the fourth is to be kept in the pharmacy.
Article 33 service of hospital pharmacy
A service guaranteeing the proper supply of medicines in the hospital shall be ensured by the holder of the authorization. This includes, also, that the advice of a pharmacist, the pharmacy is guaranteed.
Special provisions article 34 Patientenindividuelles points or blistering of medicinal products (1) In the quality management system according to paragraph 2a of the fourth section are in particular to make the following regulations: 1 the selection of pharmaceutical products, which for a set or a Neuverblisterung principle in question or which are suitable for the job or the Neuverblisterung 2nd to deciding which kept drugs for concurrent use may not in the same single container or verblistert in the same single blister can be , 3 to the decision, in which exceptional cases of a written medical request on a to be taken before placing or blistering Division of tablets, as far as otherwise the supply can not be guaranteed and proven validation of stability of their quality over the durability period of the blisters or the reusable container, if necessary, can be followed, although the subsequent changing of the finished product should be prevented in principle, 4. intermediate storage and labelling of entblisterten medicines , 5. the technical and organizational measures, to get the quality of entblisterten medicines and to avoid in particular cross-contamination and mix-ups, including the review of their effectiveness, 6 for calibration, qualification, maintenance and cleaning of the blister machines, as far as used to, or other critical pieces of equipment or devices, 7 the primary packaging materials and their quality tests, 8 to the preparation instructions and the production of logs according to § 7 , 9 to the hygiene plan as well as 10 to the hygienic behavior of staff at the workplace and to the type of protective clothing for the drug manufacturing, including the manner and frequency of changing operations.
(2) the staff must be sufficiently qualified for the activities and are regularly trained. the training must be documented. The manpower required with regard to article 3, paragraph 2, sentence 1 arises from the extent of the production.
(3) the patient-specific bodies or blistering is by way of derogation from § 4 paragraph 2 to make b in a separate room, which must be used solely for this purpose. The room must be of adequate size to perform various operations in areas specifically allocated. His walls and surfaces, as well as the floor must be easy to clean, so that the environmental risk of contamination for the medicines is minimal. Access and insertion of materials should be made at least in the automatic blistering through a gap (lock) to maintain a quality suitable in the production room. Section 4a shall apply accordingly. Set 1 and set 4 cannot be derogated from, if the points or the manually made blistering of medicines in exceptional cases for a single patient is to be made.
(4) following information must emerge from the labelling of the medicinal product newly packaged: 1 the name of the patient, 2. contained medicines and their batch names, 3. the expiration date of the newly collected medicinal and its batch number, 4. the instructions for Administration, 5. any indication of storage as well as 6 issuing Pharmacy and, if different, of the manufacturer.
The leaflets contained medicinal pursuant to § 11 paragraph 7 of the German medicines Act to add are the newly packaged medicines.
Section 35 in particular specifications to meet 1 to the medicinal products to be used as well as the primary packaging materials and their quality checks, 2. the technical and organizational measures, to contamination, to avoid cross contamination and mix-ups, including the review of their effectiveness, 3. for calibration, are pharmaceutical manufacturing for parenteral use (1) In the quality management system according to paragraph 2a of the qualification, maintenance and cleaning of the equipment and the manufacturing area , 4 to the validation of processes affecting product quality, methods and systems and the revalidation. aseptic manufacturing process at the end of each working day, including production staff involved, 5 to the critical equipment or devices, 6 to the preparation instructions and manufacturing protocols pursuant to § 7 or article 8, 7 for a possible transport of manufactured medicines, 8 to the hygiene measures, as well as 9 to the hygienic behavior of staff at the workplace and to the type of protective clothing for the drug manufacturing, including the manner and frequency of changing operations.
(2) the staff must be sufficiently qualified for the activities and are regularly trained. the training must be documented. The manpower required according to § 3, paragraph 2, sentence 1 stems from nature and scope of production.
(3) the production of Parenteral drug is to make in a separate room, which may not be used for other activities as far as it is not the production of other sterile preparations according to pharmacopoeia. Access to this space, as well as the use of materials must be made through a gap (lock), which is suitable for the maintenance of the clean room classes necessary in the preparation room. The space must serve exclusively the purpose of making parenteral pharmaceutical of reasonable size can be to perform single operations in areas specifically allocated, and the ventilation must be used as filter of reasonable effectiveness. His walls and surfaces, as well as the floor must be easy to clean, so that the environmental risk of contamination for the medicines is minimal. In the room only employees may stay at the time of manufacture, performing there appropriate activities; their protective clothing is to adapt the activities and to change at least every working day. Section 4a shall apply accordingly.
(4) as far as the medicines are subjected to no sterilization in the final container and not manufactured in a closed system, a degree of air purity for bacterial count and number of particles according to class is A definition of EC GMP Guide, to comply with Annex 1, which is published by the Ministry in the Federal Gazette in the current version, and 2. a suitable environment during the preparation and filling of 1 in the local zone for the operations required , in relation to particulate and microbial count a) b is equivalent to at least class B of the annex of this guide) or by way of derogation of class B C of the annex of the guidelines corresponds to at least class if drug quality is ensured by the applied procedure has been proven and is evidenced by appropriate validation of the process, c) or use an insulator of the class D of the annex of the guidelines corresponds to.
For the preparation of medicinal products which are manufactured in a closed system, but undergo a sterilization procedure in the final container, 1 number 2 is derogation from sentence letter a an environment required, representing at least class D of the annex to the guidelines in relation to particulate and microbial count; for the filling of these drugs, an air purity of class C must be observed.
(5) the clean-room conditions are through appropriate controls of the air to check critical surfaces and staff by means of particle - and germ number provisions during the production in open systems. Of the pharmacist responsible for the release procedure appropriate alert and action limits are set.
(6) in the production of parenteral medicines, articles 6 to 8 shall apply. The plausibility check of medical regulation must include in particular patient-specific factors as well as rule dosage and possibly resulting individual dose. The manufacturing instruction must also control of the calculations, the samples, and the to be precursors by a second person or by validated electronic procedures, as well as a leak test of the filled container provided.
§§ 35a & 35B (dropped out) - fifth section any person are offences, transitional and final provisions article 36 offences within the meaning of § 25 para 2 of the Pharmacy Law, who carries out intentionally or negligently 1 contrary to section 3 paragraph 5 sentence 1 in conjunction with sentence 2 pharmaceutical activities, 1a.
contrary to § 17 paragraph 1a sentence 1 a medicinal product issued, 1B. contrary to § 17 para. 2 b a there called a medicinal means of shipment on the market brings, 2 as a pharmacy Director a) a provision of § 2 5 or 6 set 1, 2 or 3 on the representation of the pharmacy manager contravenes, b) a quality management system is not operates contrary to Article 2a, paragraph 1, sentence 1, c) contrary to section 3 paragraph 5 sentence 1 in conjunction with article 2, paragraph 2, sentence 2 and 3 or § 3 para 5 2 pharmaceutical activities run set can be, d) contrary to article 3 par. 5 sentence 3 in conjunction with § 2 para 2 and 3 pharmaceutical activities not supervised 2 set or not supervise by a pharmacist can be e) contrary to article 15, paragraph 1, sentence 2, a medicinal product there named holds stock, f)
contrary to § 15 paragraph 2 does not ensure that a medicinal product there named is kept in stock or can be obtained in the short term, g) contrary to section 17 paragraph 1a set 1 medicines outside the operating room of the pharmacy or contrary to § 17 para 3 pharmacy medicines through self service on the market brings, h) contrary to section 17 paragraph 7 in conjunction with article 31, paragraph 1, sentence 1 or paragraph 3 , has also in connection with article 2, paragraph 2, sentence 2 and 3, medicines or give off can, i) contrary to section 17 paragraph 7 in conjunction with article 32, paragraph 1 and article 2, paragraph 2, sentence 2 and 3 on the stations or held in stock-other units of the hospital drug not not fully or reviewed in a timely manner or check with a pharmacist or contrary to § 17 section 7 in conjunction with § 32 para. 3 and § 2, paragraph 2, sentence 2 the prescribed Protocol not, not properly or fully customize, not the hospital management forward, not the competent doctor hands out or not kept or lets perform these actions not by a pharmacist, j) contrary to section 21 not guarantees that the referred measures drug risks or not capable to transport medicines are taken, k) the pharmacy not previously considers contrary to § 23 paragraph 1, l) one good contrary to § 23 ABS. 5 in conjunction with article 2, paragraph 2, sentence 2 and 3 at a visible point human-readable note on the nearest in-service pharmacies does not install or not affixed, m) contrary to section 24, subsection 1, sentence 1 a recipe collection without the required permission maintains, 3 as a pharmacy manager or member of pharmaceutical staff a) (lapsed) b) contrary to section 7 subsection 1 sentence 1 medicines according to the prescription manufactures or used other contrary to section 7 subsection 1 sentence 2 in the production as called in the prescription ingredients without the consent of the prescribing , c) (lapsed) d) emits medicines without the prescribed marking contrary to article 14, paragraph 1, e) contrary to section 16, paragraph 1, sentence 1 or set 2 a medicinal product, a raw material, or a medical device not, not properly or not in the prescribed manner stores, f) (lapsed) g) (lapsed) h) contrary to section 18 para 1 sentence 1 with the introduction of medicines does not record the information required , does not i) contrary to section 19, subsection 1, sentence 1 the prescribed evidence or contrary to article 19, paragraph 2, sentence 1 does the medicinal products mentioned therein, without having a prescription in duplicate exists, kept j) records, certificates or documents not corresponding section 22 paragraph 1 sentence 1 or unrecognizable is contrary to section 22 paragraph 1 sentence 2 or 3 records, certificates or certificates or making adjustments , k) contrary to section 22, paragraph 4, sentence 1 a record kept not or not at least thirty years and not or not at least thirty years stores or 4th as head of a hospital pharmacy) contrary to section 26 paragraph 2 in conjunction with § 21 not guarantees that the referred measures drug risks or not capable to transport medicines are taken, b) contrary to § 28 para 3 in conjunction with § 3, paragraph 5, sentence 1 and section 27, paragraph 2, sentence 1 pharmaceutical activities run can be , c) contrary to article 28 paragraph 3 in conjunction with § 3, paragraph 5, sentence 3 and section 27, paragraph 2, sentence 1 pharmaceutical activities failed to supervise or oversee by a pharmacist can, d) contrary to section 31, paragraph 1, sentence 1, § 3 or 4 in conjunction with § 17 paragraph 5 sentence 1, in connection with article 27 paragraph 2, sentence 1, medicines has, or can give or e) contrary to § 32 para 1 in conjunction with § 27 para 2 sentence 1 on the Stations or medicines in stock held in other units of the hospital not, not fully or not in time check or check with a pharmacist or violates article 32 para 3 in conjunction with article 27, paragraph 2, sentence 1 not, not properly or completely customize the prescribed Protocol, not the hospital management leads to, not the competent doctor hands out or keep or lets perform these actions not by a pharmacist.
Article 37 transitional provisions (1) on pharmacies, which before the 11 June 2012 a permit has been granted pursuant to article 1, paragraph 2, also in conjunction with section 2, paragraph 4, of the pharmacy Act, are paragraphs 2 a, 4 paragraph 1 set to apply 2, paragraph 1(a), article 34, paragraph 3, sentence 1 and 4 and § 35 paragraph 3 sentence 2 from June 1, 2014; up to this point, the rooms must still conform to regulations force until June 11, 2012.
(2) on pharmacies, which before the 11 June 2012 a permit has been granted pursuant to article 1 paragraph 2, also in conjunction with section 2, paragraph 4, of the pharmacy Act, § 35 paragraph 5 at which is June 1, 2013 to apply; up to this point the clean room requirements must conform least class A for the local zone and class C for the surrounding area.
Appendix 1 (dropped out) - Appendix 2 (dropped out) - Appendix 3 (dropped out) - Appendix 4 (dropped out) -.
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