Regulation On The Operation Of Pharmacies

Original Language Title: Verordnung über den Betrieb von Apotheken

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Regulation on the operation of pharmacies (pharmacy operating order-ApBetrO)

unofficial table of contents

apBetrO

date of release: 09.02.1987

full quote:

" pharmacy operating order in the Version of the notice of 26. September 1995 (BGBl. 1195), as last amended by Article 2a of the Regulation of 6 June 2008. March 2015 (BGBl. I p. 278) "

:Recaught by Bek. v. 26.9.1995 I 1195;
Last modified by Art. 2a V v. 6.3.2015 I 278

For details, see Notes

Footnote

(+ + + text evidence: 1.7.1987 + + +)
(+ + + changes due to change due to United Vtr. § § 2, 3, 17 and 35 + + +) unofficial table of contents

content overview

First section
General specification
§ 1 Scope
§ 1aTerms of Use
Second section
The operation of public pharmacies
§ 2pharmacy ladder
§ 2aquality management system
§ 3pharmacy personnel
§ 4Nature, size and Establishment of the pharmacy premises
§ 4aHygienic Measures
§ 5Scientific and other tools
§ 6General provisions on the Manufacturing and Testing
§ 7Prescription Medicines
§ 8 Defecturation medicine
§ 9(omitted)
§ 10(omitted)
§ 11Starting Materials
§ 11aWork on work order
§ 12Do not check Medicinal products manufactured in pharmacy and medical devices subject to pharmacies,
§ 13Containers
§ 14Labeling
§ 15 Prefend
§ 16Storage
§ 17 Acquisition and supply of medicinal products and medical devices
§ 18Medicinal products imports
§ 19Acquisition and release of veterinary medicinal products subject to medical prescription
§ 20 Information and advice
§ 21Drug risks, non-marketable treatment Medicines
§ 22General documentation
§ 23 Service ready
§ 24Recipe collection points
§ 25(omitted)
Third section
The operation of hospital pharmacies
§ 26Regulations to apply
§ 27Head of hospital pharmacies
§ 28Staff of the Hospital pharmacy
§ 29Rooms and equipment of the hospital pharmacy
§ 30Vorratshaltung in der Krankenhausapotheke
§ 31levy in the hospital pharmacist Hospital pharmacy
§ 32Review of stocks of medicinal products and medical devices subject to pharmacovigilance on the Stations
§ 33Service of the hospital pharmacist
Fourth Section
Special Rules
§ 34 Patient-specific points or blister of medicinal products
§ 35Manufacture of medicinal products for parenteral use Application
Fifth Section
Administrative Offences, Transitions-and Final rules
§ 36Administrative Offences
§ 37 Transitional provisions
§ 35a(omitted)
§ 36(omitted)
§ 37(omitted)
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First Section
General Specification

Non-Official Table of Contents

§ 1 Scope

(1) This Regulation shall apply to the establishment and establishment of public pharmacies, including hospital pharmacies, branch and emergency pharmacies, as well as hospital pharmacies. Their rules set out how to ensure proper care for the population with medicines and medical devices subject to pharmacies.(2) This Regulation shall not apply to the pharmacy establishment in so far as a permit has been granted in accordance with § 13, § 52a or § 72 of the Medicines Act.(3) The Medical Devices Operator Regulation, as amended by the announcement of the 21. August 2002 (BGBl. I p. 3396) and the Medical Devices Safety Planning Regulation of 24. June 2002 (BGBl. 2131), in the current version, remain unaffected. Non-official table of contents

§ 1a Definitions

(1) Hospital serving pharmacies are public pharmacies, according to § 14 (4) of the Law on pharmacy services a hospital.(2) Pharmaceutical staff are pharmacists, pharmacists, pharmacists, pharmacists, pharmacy assistants, pharmacy assistants, pharmaceutical assistants, as well as persons who are trained as a pharmacist or as a profession. of the pharmaceutical-technical assistant.(3) Pharmaceutical activity within the meaning of this Regulation is:
1.
the development and manufacture of medicinal products,
2.
the testing of starting materials or pharmaceuticals,
3.
the release of medicines,
4.
the information and advice on medicines,
5.
the review of medicines, as well as the Observation, collection and evaluation of pharmaceutical risks and medication errors in hospitals or in hospitals pursuant to Section 14 (8) of the Pharmacy Act relating to the supply of medicinal products, or in the cases referred to in healthcare facilities within the meaning of § 12a of the Pharmacy Act,
6.
the medication management, with which the entire medication of the patient, including the Self-medication, repeatedly analyzed with the goals of improving drug therapy safety and therapy remorse by recognizing and solving drug-related problems.
(4) Patient-specific points are the Single-request and patient-related manual repackaging of ready-to-use medicaments for certain acceptance times of the patient in a re-usable container.(5) Patient-individual Blister is the manual or machine-based re-packaging of ready-to-use medicinal products made on a single request for specific patient-acceptance times of the patient in a non-reusable Container.(6) The starting material shall be any substance used in the manufacture of a medicinal product or any preparation of substances other than packaging material.(7) Primary packaging materials are containers or sheaths which come into contact with the medicinal products.(8) Prescription medicinal product is a medicinal product which is produced in the pharmacy on a case-by-case basis on the basis of a prescription or on any other requirement of a single person and not in advance.(9) Defecturated medicinal product is a medicinal product which is produced in the normal course of pharmacy in advance on one day in up to one hundred packages ready for delivery or in a quantity corresponding to this.(10) Pharmacy common goods are:
1.
Medical devices that are not subject to pharmacy requirements,
2.
Medium as well as objects and information carriers that directly serve or promote the health of humans and animals
3.
means for body care,
4.
checker,
5.
chemicals,
6.
reagents,
7.
Laborbedarf,
8.
Pest control and plant protection products, and
9.
Means for breeding animals.
(11) Pharmacy-usual services are services that serve or promote the health of humans or animals, including: In particular:
1.
advising
a)
on health and nutrition issues,
b)
in the health education and education area,
c)
to precautionary measures,
d)
about medical devices,
2.
performing simple health tests,
3.
the patient-specific customization of medical devices, as well as
4.
health-related information.
(12) In-process checks are carried out during the manufacture of a medicinal product for monitoring and, where necessary, adaptation of the process in order to ensure that the Medicinal products is of the expected quality; in the manufacture of sterile medicines, in particular Parenteralia, the monitoring of the environment or equipment is part of the in-process controls.(13) Critical equipment or equipment shall be those which come into contact with the starting materials or medicinal products or which may have a different material impact on the quality or safety of these products.(14) Calibration is a process by which, under specific conditions, the relationship is determined between, on the one hand, the values indicated by a measuring instrument or a measuring system, or the values obtained from a measuring instrument or a measuring system, or the values obtained by a measuring instrument or a measuring system. Material measurement results and, on the other hand, the corresponding values of a reference standard.(15) Qualification is the provision of a documented proof that proves with high certainty that a specific item of equipment or a specific environmental condition for the manufacture or testing of the medicinal product is the first the quality of the product.(16) Validation is the provision of a documented proof that proves with high certainty that a specific process or standard working method is used to produce and verify a medicinal product that is pre-determined Quality characteristics.(17) Production in the closed system is the transfer of sterile starting materials or solutions into a pre-sterilized closed container, without the contents coming into contact with the outer environment. name="BJNR005470987BJNG000201307 " />

Second Section
The Operation of Public Pharmacists

Non-official table of contents

§ 2 Head of pharmacy

(1) Head of pharmacy is
1.
at a pharmacy which is based on § 1 para. 2 of the law is operated by the pharmacy, the holder of the licence in accordance with § 2 of the pharmacy law, in the case of leasing, the tenant,
2.
at a pharmacy or Two-way mortgage administered in accordance with § 13 or § 16 of the law on pharmacy, the holder of the authorization,
3.
at a pharmacy, which according to § 17 of the law is operated via pharmacy, the pharmacist appointed by the competent authority and instructed by the management,
4.
at a main mortgage pursuant to § 2 para. 5 No. 1 of the pharmacy law of the holders of the permission in accordance with § 2 para. 4 of the pharmacy law,
5.
at a branch pharmacy pursuant to § 2 para. 5 No. 2 of the pharmacy law of the Operator designated by the operator.
(2) The pharmacy manager has to direct the pharmacy personally. It shall be responsible for ensuring that the pharmacy is operated in compliance with the rules in force. In addition to the head of pharmacies referred to in paragraph 1 (5), the operator shall also be responsible for compliance with the rules applicable to the operation of pharmacies.The Head of Pharmacies shall notify the competent authority of any other professional or commercial activity before it is taken up.(4) In addition to medicinal products and medicinal products subject to pharmacies, the head of pharmacies shall be allowed to offer or maintain the goods referred to in Article 1a (10) only to a degree which shall ensure the proper functioning of the pharmacy and the primacy of the products. Pharmaceutical supply contract is not affected. The first sentence shall be applied in accordance with the services provided for in Article 1a (11) of the pharmacy.(5) In so far as he temporarily does not take his responsibility for the personal management of the pharmacy himself, the pharmacist must be represented by a pharmacist. The representation may not exceed a total of three months per year. The competent authority may allow representation beyond that period if there is an important reason lying in the person of the pharmacist.(6) If a pharmacist cannot fulfil his obligation under the first sentence of paragraph 5, he may be represented by a pharmacist or a pharmacist, provided that he or she, in particular with regard to his/her knowledge and abilities, and, in the course of a period of at least six months prior to the start of representation, was employed in a public pharmacy or hospital pharmacy for at least six months. The head of pharmacy may not be represented for more than four weeks a year by pharmacists or pharmacist assistants. The head of the pharmacist shall inform the competent authority, indicating the representative, prior to the date of the representation. The sentences 1 to 3 do not apply to the representation
1.
of the holder of a permit pursuant to § 2 paragraph 4 of the Pharmacy Act,
2.
the head of a hospital-care pharmacy as well as
3.
of the head of a pharmacy to which the Special provisions of § 34 or § 35 apply.
(7) The pharmacist or pharmacist assistant or pharmacist who is responsible for the representation has the duties of a pharmacist during the period of representation. Non-official table of contents

§ 2a Quality Management System

(1) The pharmacist must have a quality management system according to the type and extent of the carry out pharmaceutical activities. The quality management system must be used to define and document the operational processes. The quality management system must, in particular, ensure that the medicinal products are manufactured, tested and stored in accordance with the state of the art and technology, and that confusion is avoided and sufficient advisory capacity is provided for: is done.(2) The Head of Pharmacies shall ensure, within the framework of the Quality Management System, that self-inspections are carried out on a regular basis by pharmaceutical personnel for checking the operational procedures and, if necessary, corrections shall be carried out. In addition, the pharmacy should take part in regular external quality reviews.(3) The Head of Pharmacies shall be responsible for documenting the verifications and the self-inspections referred to in paragraph 2 and the measures taken if necessary. Non-official table of contents

§ 3 Pharmacy staff

(1) Pharmacists may only be used according to their training and knowledge. , and shall be regularly informed of the care taken in the course of the activities concerned. The instruction must also cover the theory and application of the quality management system and the specific characteristics of the medicinal products which are manufactured, tested or stored.(2) In order to ensure the proper operation of the pharmacy, the necessary personnel, in particular the pharmaceutical personnel, must be present in sufficient numbers. The additional staff required to supply a hospital shall be determined by the nature and extent of a medically appropriate and adequate supply to the hospital with medicinal products and medical devices subject to pharmacotherapy. Consideration of size, type and performance structure of the hospital. Sentence 2 shall apply in accordance with the provision of facilities within the meaning of Section 12a of the Pharmacies Act.(3) (omitted) (4) The evaluation of the analysis and the consultation within the scope of a medication management must be carried out by a pharmacist of the pharmacy.(5) It shall be prohibited to carry out or have carried out pharmaceutical activities by persons other than pharmaceutical personnel, unless otherwise provided for in paragraph 5a. In this respect, the person concerned must be powerful in the German language and must have knowledge of the law in force in Germany, as is necessary for the exercise of their respective activities. Pharmaceutical activities carried out by pharmaceutical and technical assistants, pharmaceutical assistants or persons who are in the training of pharmacists or the profession of pharmacological assistant, shall be supervised by the head of the pharmacist or supervised by a pharmacist. Pharmaceutical assistants may not release any medicinal products.(5a) The refilling, including bottling and packaging or marking of medicinal products, may also be carried out under the supervision of a pharmacist by other than the pharmaceutical staff, in so far as it concerns pharmacies 'helpers, pharmacists' assistants, pharmaceutical and commercial employees, as well as persons who are in training as a profession of pharmacocommercial employee. In addition, the pharmaceutical personnel may be supported by the other staff of the pharmacy referred to in the first sentence
1.
in the manufacture and testing of the medicines,
2.
when testing the starting materials,
3.
by operation, maintenance, and Maintenance of work equipment,
4.
during filling and packaging or marking of medicines, as well as
5.
in the preparation of the medicinal products for delivery.
The staff employed for the preparation of the first sentence or the support provided for in the second sentence shall be required for these tasks in accordance with be verifiably qualified at the beginning and thereafter on an ongoing basis by the pharmaceutical personnel on the care required for the respective activities.(6) In order to supply a hospital with the exception of delivery, the Head of Pharmacies shall only be allowed to use personnel who are active in his or her establishment. Sentence 1 shall apply to the supply of residents of a facility to be supplied within the meaning of Section 12a of the Pharmacies Act. Non-official table of contents

§ 4 Nature, size and setup of the pharmacy premises

(1) The operating rooms must be in accordance with type, size, number, Location and equipment shall be suitable for proper pharmacy operation, in particular for the proper development, manufacture, testing, storage, packaging and proper delivery of medicinal products or the delivery of pharmacies liable to pharmacies. To ensure medical products and to provide information and advice on medicinal products or medical devices, including by means of telecommunications equipment. The operating rooms are
1.
to be separated by walls or doors
a)
from other commercial , also in connection with activities for which the head of pharmacy has a permit pursuant to Section 52a of the Medicines Act, and
b)
of public transport spaces and store streets
2.
by appropriate action against to protect unauthorized access,
3.
adequately illuminate and ventilate and, if necessary, air-conditioned,
4.
keep in perfect design and hygienic condition and
5.
so arrange that each room without Leaving the pharmacy is attainable (space unit).
sentence 2 (1) (a) does not apply to the manufacture of medicinal products for which permission is required in accordance with § 13 of the Medicines Act.(2) The pharmacy must consist of at least one officer, a laboratory, a sufficient storage room and a night service room. The laboratory shall be equipped with a deduction with a suction device or with a corresponding device which fulfils the same function. The floor area of the operating rooms referred to in the first sentence shall be at least 110 square metres. In the calculation of the base area, the separate rooms referred to in § 34 (3) and § 35 (3) shall not be taken into account, as well as spaces to be separated from the premises of the pharmacy in accordance with the second sentence of paragraph 1 (1) (1) (a). § 29 (1) and (3) shall apply mutagenic to the pharmacies which are responsible for the hospital.(2a) Offizin must have access to public transport areas and should be accessible without barriers. It must be designed in such a way as to ensure that the priority of the supply of medicinal products is not adversely affected and that there is sufficient room for the essential tasks carried out in the office, in particular the advice of patients and customers. The officer shall be set up in such a way as to ensure that the confidentiality of the advice, in particular in the places where medicinal products are delivered to customers, shall be maintained in such a way as to ensure that the advice of other customers is as far as possible is prevented.(2b) For the manufacture of medicinal products which are not intended for parenteral use, provision should be made for a separate workplace. The place of work must be separated from at least three sides from other areas of the pharmacy, provided that this workplace is not located in an operating room which at the same time serves exclusively as a laboratory. Its walls and surfaces, as well as the floor, must be easy to clean, so that the risk of contamination from the medicinal product to be produced is minimal. The workplace may also be used for the manufacture of medical devices or pharmacies in accordance with § 1a (10) (2), (3) or (9).(2c) A separate workplace should be provided for the manufacture of medicinal products which are drugs or mixtures of drugs, or for the other processing of drugs as starting materials. The second sentence of paragraph 2b and the third sentence shall not apply.(2d) The storage space must be sufficiently large and allow for proper storage of the products stored or sold in the pharmacy. A storage position below a temperature of 25 degrees Celsius must be possible. A separate and correspondingly marked storage area shall be provided for medicinal products or raw materials to be deposited in accordance with Section 21 (7) and for counterfeit medicinal products which are to be kept safe in accordance with section 21 (8). To the extent that medicinal products are delivered outside the opening hours of the pharmacy, it is necessary to ensure that the necessary storage temperatures for the medicinal products concerned are complied with, and that unauthorised access must be excluded. Pharmacies supplying hospitals with medicinal products must hold separate storage rooms or at least separate and appropriately labelled storage areas for these medicinal products.(3) A two-gas pharmacy must consist of at least one officer, a sufficient storage room and a night service room. The first and third sentences of paragraph 2 shall not apply.(4) Paragraph 1, second sentence, point 5 shall not be applied to
1.
Storage spaces exclusively for the supply of medicinal products to hospitals or to the supply of residents of: facilities to be supplied within the meaning of Section 12a of the Pharmacy Act,
2.
Rooms dealing with the sale of goods, including electronic commerce, with medicinal products , as well as related advice and information,
3.
Rooms used for the manufacturing activities according to § 34 or § 35, or
4.
the night service room.
However, these rooms must be close to the other operating rooms. The use of storage or manufacturing facilities within the hospital to be supplied or the facility to be supplied within the meaning of § 12a of the Pharmacies Act is not permitted.(5) (omitted) (6) Essential changes in the size and location of the premises or the equipment of the premises or their use shall be notified to the competent authority in advance.(7) The pharmacy must be equipped with equipment in such a way that pharmaceuticals, in particular in the forms of administration
1.
solutions, emulsions, suspensions,
2.
Ointments, Creams, Gels, Pastes,
3.
Capsules, Powder,
4.
Drug mixtures as well as
5.
Zäpfchen and Ovula
can be properly manufactured. The manufacture of sterile medicinal products must be possible, in so far as it is not a medicinal product for parenteral use. If there is no device for the production of water for injections, water must be held in sufficient quantity for injection as a ready-to-use product.(8) In the pharmacy, equipment and test equipment must be available for the examination of the medicinal products manufactured in the pharmacy and their starting materials, in accordance with the recognised pharmaceutical rules. Non-official table of contents

§ 4a Hygienic measures

The pharmacy manager must be responsible for the staff and the premises used for the manufacture of medicinal products. shall take appropriate hygiene measures to ensure the microbiological quality of the medicinal product concerned. In particular, hygiene measures should be defined as follows:
1.
the frequency and type of cleaning of the manufacturing areas or manufacturing spaces,
2.
as far as necessary, the frequency of disinfection of the manufacturing areas and manufacturing spaces, as well as
3.
the means and devices to be used.
The measures must be set in a hygienic plan in writing. The implementation of the hygiene measures must be documented on a regular basis. Without prejudice to the hygiene plan, it is necessary to make provisions on hygienic behaviour in the workplace and on the protective clothing of the staff. Non-official table of contents

§ 5 Scientific and other tools

In the pharmacy you must be present
1.
Scientific tools for the preparation and testing of medicines and starting materials the accepted pharmaceutical regulations are necessary in the course of pharmacy operations, in particular the pharmacopoeia,
2.
scientific aids, which are available for information and advice to the customer on medicinal products,
3.
scientific tools that provide information and advice on the exercise of medicine, dentistry, and dentistry or veterinary medicinal products are required for medicinal products,
4.
Texts of legislation applicable to pharmacies.
The scientific and other aids must be kept up-to-date and may also be available on electronic media. Non-official table of contents

§ 6 General rules on manufacture and testing

(1) Medicinal products manufactured in pharmacy, must be of the quality required by pharmaceutical science. They must be manufactured and tested in accordance with the accepted pharmaceutical rules; if the pharmacopoeia contains the relevant rules, the medicinal products must be prepared and tested in accordance with these rules. It is also possible to use other methods for the test and to use other devices than are described in the German Pharmacopoeia, provided that the same results are obtained as with the methods and apparatus described. Where necessary, the examination shall be repeated in reasonable periods.(2) In the manufacture of medicinal products, provision should be made for the prevention of mutual adverse effects on the medicinal products, as well as any confusion between the medicinal products and the starting materials and the packaging and labelling materials. .(3) The examination of the medicinal products may also be carried out under the responsibility of the pharmacist outside the pharmacy:
1.
in an establishment, for which a permit according to § 13 of the Medicinal products act,
2.
in an establishment in a Member State of the European Union or of the European Economic Area, for which, according to the National law shall be authorised in accordance with Article 40 of Directive 2001 /83/EC of the European Parliament and of the Council of 6 June 2001 on the November 2001 on the Community code relating to medicinal products for human use (OJ L 327, 28.12.2001, p. 67), as last amended by Directive 2011 /62/EU (OJ L 311, 28.11.2011, p. 74), as amended, or a permit referred to in Article 44 of Directive 2001 /82/EC of the European Parliament and of the Council of 6 June 2001, of the European Parliament and of the Council of 6 June 2001 on the application of the European Parliament and of the Council to the November 2001 on the Community code relating to veterinary medicinal products (OJ L 327, 28.12.2001, p. 1), as last amended by Regulation (EC) No 596/2009 (OJ L 311, 28.11.2009, p. 14), as amended,
3.
in an establishment for which a permit pursuant to Article 1 (2) in conjunction with § 2 of the Pharmacies Act is granted, or
4.
by an expert within the meaning of Section 65 (4) of the Medicinal Products Act.
The person responsible for the examination of the The holding or the person referred to in point 4 of the first sentence shall certify that the medicinal product has been tested in accordance with the recognised pharmaceutical rules and the required date and results of the test, and the date and results of the examination. Quality (test certificate). The results obtained from the test certificate shall be based on the release in the pharmacy. At least the identity of the medicinal product must be established in the pharmacy and records shall be kept of the tests carried out.(4) The provisions of the Medical Devices Act concerning the production, special production and self-production of medical devices remain unaffected. Non-official table of contents

§ 7 Prescription Medicines

(1) If a medicine is prescribed for the purposes of the exercise of the Medicine, dentistry or veterinary medicine are justified, it must correspond to the prescribtion. Other starting materials other than those mentioned in the prescription may not be used in the manufacture without the consent of the prescribing. This does not apply to starting materials, unless they have their own medicinal effect and cannot have a negative effect on the effect of the medicinal product. If a prescription contains a discernible error, if it is illegible or if there are other concerns, the medicinal product must not be manufactured before the ambiguity is eliminated. In the case of individual production without prescription, the sentence 4 shall apply accordingly.(1a) A medicinal product for prescription shall be prepared in accordance with a written declaration of manufacture which has been prepared beforehand, to be signed by a pharmacist or, in the case of a representative, by the person authorised to represent the pharmacy, in accordance with Article 2 (6). is. The manufacturing instruction must at least make stipulations
1.
for the production of the respective pharmaceutical form, including the manufacturing technique and the Equipment,
2.
for the plausibility check referred to in paragraph 1b,
3.
to primary Packaging materials and marking,
4.
for Inprocess Controls, as far as they are practicable,
5.
to prepare the workplace and
6.
for release and documentation.
Insofar as it is They are to be adapted to the respective pharmacy establishment in order to be standardized and general to third party manufacturing instructions.(1b) The requirement for the manufacture of a prescription drug is to be assessed by a pharmacist according to pharmaceutical aspects (plausibility check). In particular, the plausibility check must take into account the following:
1.
the dosage,
2.
the application type,
3.
the type, quantity, and compatibility of the starting materials among themselves and their consistent quality in the ready-made formulation medicinal product over its shelf life as well as
4.
the shelf life of the prescription drug.
The A plausibility check is to be documented by a pharmacist or, in the case of representation pursuant to § 2, paragraph 6, by the person entitled to represent it.(1c) The preparation of the medicinal product for formulation must be documented by the producing person (production protocol) and shall in particular include:
1.
Type and quantity of starting materials and their batch names or test numbers,
2.
the manufacturing parameters,
3.
to the extent that in-process controls are provided, the result of which,
4.
is the name of the patient and the Prescribing physician or dentist,
5.
for medicinal products for use in animals, the name of the keeper and animal species and the name of the prescribers. Veterinarian,
6.
for pharmaceutical products manufactured on the customer's request, the name of the customer, and
7.
the name of the person who made the prescription drug.
Instead of the name of the patient, keeper or customer according to sentence 1, number 4, 5 or 6, a reference can also be made to The production number shall be documented. The production protocol shall be supplemented by a pharmacist or, in the event of representation pursuant to Article 2 (6), by the person entitled to represent it, with the result of the organoleptic examination carried out for the release, and its confirmation that: the medicinal product has been produced in accordance with the medicinal product for prescription (clearance). The release must be made before the delivery to the patient.(2) In the case of a medicinal product for medicinal products, an analytical test may be carried out, provided that the quality of the medicinal product is determined by the production process, the organoleptic examination of the finished product and, where provided for, by: the results of the in-process controls are guaranteed. Non-official table of contents

§ 8 Defecturation medicine

(1) A defect-processing drug is after a written production instruction , which is to be signed by a pharmacist of the pharmacy. The manufacturing instruction must, in particular, be defined as follows:
1.
on the starting materials to be used, the primary packaging materials and the Equipment,
2.
to the technical and organizational measures to avoid cross-contamination and confusion, including preparation of the workplace,
3.
to determine the individual work steps, including the set values, and as far as practicable, of inprocess controls,
4.
for labelling, including the date of manufacture and the date of decay or the inspection, and, where necessary, on storage conditions and precautions as well as
5.
for release to the market within the meaning of § 4 (17) of the Medicines Act.
(2) The production is subject to the manufacturing instructions for The date of manufacture must be documented by the person producing the product (production protocol); the contents of the protocol must be followed by all the important activities relating to the manufacture of such products. The manufacturing protocol must identify the underlying manufacturing instruction and, in particular, include:
1.
the manufacturing date and the Batch designation,
2.
the starting materials used and their weighing or dimensions and their batch designations or test numbers,
3.
the results of the in-process controls,
4.
the manufacturing parameters,
5.
the total yield and, where applicable, the number of submitted forms of administration,
6.
the Expiry date or date as well as
7.
the signature of the person who manufactured the medicine.
The manufacturing protocol is from a pharmacist (3) For the examination of medicinal products for defecturation, a test instruction is to be prepared which is to be found by a pharmacist at the pharmacy. is signed. The test instruction must contain at least information on the sampling, the test method and the type of tests, including the permissible target or limit values.(4) The examination shall be carried out in accordance with the test instruction referred to in paragraph 3 and shall be documented by the person who carried out the examination (test protocol). The audit trail must name the underlying audit statement and, in particular, contain evidence
1.
at the date of the audit,
2.
about the test results and their release by the responsible pharmacist who carried out or supervised the audit.
A non-official table of contents

§ § 9 and 10 (omitted)

- unofficial table of contents

§ 11 starting materials

(1) Only starting materials may be used for the manufacture of medicinal products , the proper quality of which is established. The test of the starting materials shall be subject to the provisions of Article 6 (1) and (3).(2) If starting materials are obtained, the quality of which is proven by a test certificate according to § 6 para. 3, at least the identity shall be established in the pharmacy. The test certificate should also provide information on the GMP-compliant production of the starting material, in so far as it is an active substance. The responsibility of the pharmacist for the proper quality of the starting materials remains unaffected. The examinations carried out in the pharmacy shall be carried out in the form of records of the name of the pharmacist who shall be subject to the examination or the examination.(3) If medicinal products which are not ready-to-use medicinal products are obtained for the manufacture of other medicinal products, paragraphs 1 and 2 shall apply accordingly. Non-official table of contents

§ 11a Activities on behalf

(1) Insofar as the pharmacy is responsible for the manufacture of medicinal products in accordance with Section 21 (2) (1b) of the Pursuant to Article 11 (3) or (4) of the Pharmacies Act, a written contract must be concluded between the pharmacy as a contracting authority and the other as a contractor, who shall be responsible for the application of the provisions of the Pharmacies Act. both farms must be available. In the Treaty, the responsibilities of each side are clearly defined. The first sentence shall apply mutatily to the examination of medicinal products manufactured in pharmacy and to the examination of starting substances provided for in the pharmacy for the manufacture of medicinal products, to the extent that this goes beyond the identity check.(2) The head of pharmacy may not order the manufacture of medicinal products until the medicinal product concerned has received a regulation of the medicinal product concerned and has not taken up any concerns after examination of the regulation. § 7 shall apply accordingly. The responsibility for the quality of the manufactured medicinal product as well as for the information and advice of the ordering physician shall remain with the pharmacy as the client. Non-official table of contents

§ 12 Examination of medicinal products not manufactured in pharmacy and medical devices subject to pharmacies

(1) Finished products not manufactured in the pharmacy shall be subject to random testing. In so doing, the examination shall not be subject to examination beyond the examination of the senses, unless there are indications that there are grounds for doubt as to the proper quality of the medicinal product. Sentences 1 and 2 apply to medical devices subject to apothecary requirements.(2) The test log to be produced must contain at least
1.
the name or the company of the pharmaceutical entrepre, in the case of medical devices of the manufacturer or his authorised representative,
2.
the name and in the case of medicinal products the pharmaceutical form,
3.
the batch name or date of manufacture,
4.
the date and time. the results of the check,
5.
the name sign of the examining pharmacist or supervising the inspection.
unofficial table of contents

§ 13 containers

Only primary packaging materials that ensure that the medicinal products are used for the manufacture of medicinal products should be used only for primary packaging. Physical, microbiological or chemical changes, which are therefore suitable for the intended purposes. Non-official table of contents

§ 14 Labelling

(1) Prescription Medicines must be placed on the containers and, where used, the outer envelopes, at least the following information:
1.
Name and address of the dispensing pharmacy and, if different, of the manufacturer,
2.
content by weight, space content, or piece count,
3.
application type,
4.
Instructions for use,
5.
Active substances by type and quantity and other ingredients according to the Type,
6.
Date of manufacture,
7.
Time to use with the note "useable until" , indicating the date, month and year and, where necessary, indication of the shelf life after opening the container or after manufacture of the ready-to-use preparation,
8.
where necessary, for special precautions, for the storage or disposal of unused medicinal products or other special Precautions to avoid hazards to the environment, and
9.
as far as the prescription drug is produced on the basis of a prescription for use in humans the name of the patient.
The information must be written in legible writing and in a permanent manner and, with the exception of the number 5, should be written in German. Where a ready-to-use medicinal product is used as the starting material for the medicinal product for prescription, the indication of the name of the ready-to-use medicinal product shall be replaced by the indication referred to in point 5. The information referred to in point 8 may also be made in an accompanying document.(1a) In so far as the medicinal products are subsets taken from finished medicinal products, the name and address of the pharmacy must be indicated in addition to the labelling required by the Medicines Act.(1b) § 5 of the GCP Regulation shall apply to the labelling of medicinal products intended for clinical trial in humans.(2) In the case of defective products, which are held in stock as ready-to-use medicinal products in a pack intended for delivery to the consumer, and
1.
medicinal products in the sense of § § § 1. 2 (1) or (2) (1) of the Medicines Act and are not intended for clinical trial in humans or
2.
Medicinal products as defined in § 2 (2) No 2, 3 or 4 of the Medicines Act,
is to be applied to § 10 of the Medicines Act. To the extent that an authorisation pursuant to section 21 (2) (1) or a registration pursuant to § 38 (1) sentence 3 of the German Medicines Act is not required for them, the indication of the approval or registration number shall not be required. The information in accordance with § 10 (1b) of the German Medicines Act can be waited.Medicinal products manufactured in pharmacy, which are not ready for use in manufacture and intended for use in food-producing animals, may be placed on the market only if the containers and, where used, the containers used are: External envelopes shall be provided with the information in accordance with § § 10 and 11 of the Medicines Act.(5) (omitted) unofficial table of contents

§ 15 stock of storage

(1) The pharmacy manager has the medicinal products and the pharmacist To maintain in stock medical devices which are necessary to ensure a proper supply of medicinal products to the population, in a quantity which is at least equal to the average requirement for one week. In addition, keep in stock in the pharmacy:
1.
Analgetika,
2.
narcotics, including opioids for injection, direct release of active ingredient release and modified release of active ingredient,
3.
Glucocorticosteroids for injection,
4.
antihistamines for injection,
5.
Glucocorticoids for inhalation for the treatment of flue gas intoxications,
6.
antifoam agent for Treatment of surfactant intoxications,
7.
medical coal, 50 grams of powder for suspension,
8.
Tetanus Vaccine,
9.
Tetanus-Hyperimmun-Globulin 250 I. E.,
10.
Epinephrine for injection,
11.
0.9 percent saline solution for injection,
12.
Verbandstoffe, disposable syringes and cannulas, catheters, transfer devices for infusions, as well as products for blood glucose determination.
(2) The pharmacy leader must ensure that The medicinal products containing the following active substances are either held in stock in the pharmacy or can be procured in the short term:
1.
Botulismus-antitoxin from the Horse,
2.
Horse Diphtheria Antitoxin,
3.
Snake Venom Immunodeficiency, polyvalent, Europe,
4.
Tollwut vaccine,
5.
Tollwut immunoglobulin,
6.
Varizella-Zoster-Immunglobulin,
7.
C1-esterase inhibitor,
8.
Hepatitis B Immunoglobulin,
9.
Hepatitis B vaccine,
10.
Digitalis-Antitoxin,
11.
Opioids in transdermal and transmucosal dosage form.
(3) The head of a pharmacy supplying the hospital must have the medicinal products necessary to ensure the proper supply of medicinal products to the patients of the hospital and, where provided for in the supply contract, medical devices in of a type and quantity equal to or greater than the average requirement for two weeks. These medicinal products and medical devices are to be listed. Non-official table of contents

§ 16 Storage

(1) Medicinal products, starting materials, medical devices, and the usual pharmacotics and testing equipment to be stored clearly and in such a way that their quality is not adversely affected and confusion is avoided. In so far as their proper quality is not established, they shall be stored separately, subject to appropriate information. This shall also apply to containers, outer sheaths, labelling material, package inserts and packaging materials. The provisions of the Ordinance on Hazardous Substances as well as the Narcotics and Medical Devices Act, including the regulations adopted for this purpose, remain unaffected. The storage instructions of the pharmacopoeia are to be observed.(2) The storage containers for medicinal products and starting materials must be such as to ensure that the quality of the contents is not impaired. They must be provided with legible and permanent inscriptions which clearly indicate the content. The use of a common scientific name shall be used. The content shall be marked by additional information to the extent that this is necessary to establish the quality and to avoid confusion. The expiry date or, where appropriate, a verification date shall be indicated on the containers.(3) (omitted) (4) (omitted) Non-official table of contents

§ 17 Acquisition and supply of medicinal products and medical devices

(1) Medicinal products may be used only be purchased from holdings authorised to supply medicinal products.(1a) Medicinal products may only be placed on the market in pharmacies operating rooms, except in the case of § 11a of the Pharmacy Act and paragraph 2a, and shall only be handed out by pharmaceutical personnel. The first sentence must be applied to medical devices subject to apothecary requirements.(2) The delivery by Boten of the pharmacy is permissible in individual cases without the permission of § 11a of the pharmacy law; in this case, the medicinal products must be packed separately for each recipient and each provided with its name and address. In accordance with the provisions of the first and second sentences of paragraph 2a and the second sentence of paragraph 2a, the first sentence of the first sentence of paragraph 2a is also applicable to the provisions of the first sentence of paragraph 2 (2) and In the case of delivery by messenters, care shall be taken to ensure that the medicinal products are delivered to the recipient in a reliable manner. If advice has not already been made in the pharmacy, the advice provided by the pharmacy's pharmaceutical staff must be carried out directly with the delivery. The provisions of Section 43 (5) of the Medicines Act concerning the delivery of medicinal products intended for use in animals shall remain unaffected.(2a) In the case of the dispatch permitted in accordance with § 11a of the Pharmacy Act, the pharmacist shall ensure that
1.
the medicine is packaged, transported and delivered in such a way as to maintain its quality and effectiveness,
2.
The medicine is delivered according to the client's specifications and the delivery is confirmed in writing if necessary. In justified cases, the pharmacist may, contrary to the information provided by the contracting authority, in particular because of the nature of the medicinal product, have the effect that the medicinal product will be delivered only against a written acknowledgement of receipt
3.
The orderer will be informed in a suitable manner if it is discernable that the dispatch of the medicinal product is not within the
4.
All medicinal products ordered, as far as they are placed on the market within the scope of the Medicines Act. may be supplied,
5.
for the case of known risks for medicinal products to the customer, possibilities for reporting such risks to the customer , the customer is informed about the risks relating to him and his/her internal defensive measures are carried out in order to avert the risks associated with medicinal products.
6.
the treated person is advised that she should contact the treating physician or the treating physician if problems with the use of the medicine are
7.
the treated person is advised to provide a telephone number as a condition for the delivery of the medicinal product by placing an order , under which it will be advised by pharmaceutical personnel of the pharmacy with permission to send pharmacy-subject medicinal products in accordance with § 11a of the pharmacy law also by means of telecommunication facilities without any additional fees; the The possibilities and times of advice are to be communicated to them,
8.
a free second delivery is initiated and
9.
a system for tracking the shipment.
The dispatch must not be performed if the product is used in a safe way to provide information or advice , which may not be carried out in a different way than personal information or advice by a pharmacist.(2b) For medicinal products containing the active substances lenalidomide, pomalidomide or thalidomide, as well as for medicinal products authorised for emergency contraception with the active substances levonorgestrel or ulipristalacetate, placing on the market is in the way of Not allowed pursuant to § 43 (1) sentence 1 of the Medicines Act.(3) The head of pharmacy may not place on the market medicinal products and medical devices subject to the obligation of pharmacy by way of self-service.(4) prescriptions of persons who are entitled to the exercise of medicine, dentistry or veterinary medicine shall be carried out in a time appropriate to the prescription.(5) The medicinal products delivered must comply with the prescriptions and the related provisions of the Fifth Book of the Social Code on the supply of medicinal products. If a prescription contains a mistake which can be discernible for the donor, if it is not legible or if there are other concerns, the medicinal product must not be delivered before the ambiguity is removed. The pharmacist shall record and sign any changes to the prescription or, in the case of prescription, to be added to the electronic prescription in electronic form and the overall document with a qualified electronic mail order. Signature according to the signature law. The provisions of the Narcotics presenter Regulation shall remain unaffected.(5a) By way of derogation from the first sentence of paragraph 5, the pharmacist may, during the period referred to in Article 23 (1), second sentence, another person, with the prescribed medicinal product, in accordance with the field of application and in the manner and quantity of the active ingredients. the same medicinal product, as well as in the pharmaceutical form and pharmaceutical quality, if the prescribed medicinal product is not available and there is an urgent case for the immediate use of the medicinal product is required.(6) In the case of the delivery of medicinal products, prescribtion and, in the case of a prescription pursuant to Section 3a (1), first sentence, of the Regulation on prescription of medicinal products shall be indicated on the copy of the prescription, or in the case of the prescription. Add a prescription in electronic form to the electronic prescription
1.
the name or the Company of the owner of the pharmacy and its address,
2.
the name symbol of the pharmacist, the pharmacist assistant, the pharmacist or the pharmacist assistant, the medicinal product or the pharmacist who has supervised the charge; in the case of prescription in electronic form, the name symbol shall be replaced by an electronic signature in accordance with the signature law, with the To ensure traceability to the respective signatory and its documentation,
3.
the date of the delivery,
4.
the price of the medicine,
5.
referred to in § 300 para. 3 No. 1 of the Fifth Book of the Social Code National uniform marks for the finished pharmaceutical product, insofar as it is intended for use in humans.
By way of derogation from point 2, the head of pharmacy may have the power to distinguish prescriptions in accordance with section 3 (5) to pharmaceutical-technical assistants. In the cases referred to in the second sentence of paragraph 5 and in the case of prescriptions which do not remain in the pharmacy, the pharmaceutical-technical assistant shall, in all other cases, immediately after delivery of the medicinal products, prescribe the prescribings to a pharmacist. .(6a) In the case of the acquisition and delivery of blood preparations, sera from human blood and preparations from other substances of human origin, as well as genetically engineered plasma proteins, for the treatment of haemostasis disorders, are Trace the following information:
1.
the name of the medicine,
2.
the batch name and quantity of the medicine,
3.
the date of purchase and the amount of the medicine Delivery,
4.
Name and address of the prescribing physician as well as name or company and address of the supplier and
5.
The name, first name, date of birth and address of the patient, or the name and address of the prescribing physician in the case of the medical practice.
(6b) and the supply of medicinal products containing lenalidomide, pomalidomide or thalidomide, and the acquisition of these active substances, the following information shall be recorded:
1.
the name and the batch name of the medicine or the active substance,
2.
the amount of Medicinal product or active substance,
3.
the date of purchase,
4.
the date of the Levy,
5.
Name or company and address of the supplier,
6.
Name and address the prescribing doctor or the prescribing physician and
7.
the name and address of the person for whom the medicinal product is intended.
Copies of the forms referred to in Section 3a (7) of the Ordinance on prescription of medicinal products to the Federal Institute for Medicinal Products and Medical Devices shall be added to the date of the association according to the first sentence of the first sentence.(6c) Pharmacies may not obtain medicinal products from other pharmacies. Sentence 1 is not applied to medicinal products,
1.
which, in accordance with Section 52a (7) of the Medicinal Products Act, in the Framework of the usual pharmacy operation of pharmacies,
2.
which are obtained from pharmacies, for which the same permission pursuant to § 1 paragraph 2 in conjunction with § 2 4.
3.
may be obtained from pharmacies pursuant to § 11 (3) or (4) of the Pharmacy Act,
4.
after a pharmacy has been closed to a subsequent license holder after the pharmacy law, or
5.
who are referred to in urgent cases by a pharmacy; an urgent case exists if the immediate use of the medicinal product is required and if the medicine is can not be obtained in time or in good time.
If medicinal products are obtained from pharmacies or passed on to other pharmacies, the batch name of the medicinal product must also be documented and the product also must be Receivers are communicated.(7) In so far as public pharmacies supply hospitals with medicinal products, the provisions of § 31 (1) to (3) and § 32 shall apply accordingly. The first sentence shall apply to medical devices subject to pharmacies.(8) The pharmaceutical staff shall be able to respond appropriately to a discernible drug abuse. If there is a reasonable suspicion of abuse, the levy shall be refused. Non-official table of contents

§ 18 Imports of medicinal products

(1) Are manufactured medicinal products in accordance with § 73 (3) or (3a) of the German Medicines Act (Medicines Act) in the The scope of this Regulation shall be used to record the following information
1.
the name of the imported medicinal product,
2.
the name or the company and the address of the pharmaceutical entrepre,
3.
the batch name, the amount of the medicine and the dosage form,
4.
the name or the company 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 the prescribing veterinarian,
7.
the date the order and the levy,
8.
the name of the pharmacist who has made the product or supervises the levy. To the extent that, for reasons of pharmaceutical safety, special instructions are provided, they shall be communicated at the time of delivery. This communication shall be recorded.
(2) Ready-to-use medicinal products which are brought into the scope of this Regulation from a Member State of the European Communities beyond the scope of Article 73 (3) of the Medicines Act, may be placed on the market for the first time by a pharmacy only if they are tested in accordance with § 6 (3), sentence 1 to 3, and the required quality is confirmed. The test may not be carried out if the medicinal products are examined in the Member State in accordance with the legislation in force there and there are documents relating to the test protocol. Non-official table of contents

§ 19 Acquisition and delivery of veterinary medicinal products subject to medical prescription

(1) On the acquisition and delivery of Medicinal products subject to medical prescription, intended for use in animals, must be carried out in a timely manner. The following must be considered as sufficient proof:
1.
for the acquisition of the ordered compilation of the Delivery notes, invoices or receipts of goods resulting from the following:
a)
Name or Company and Address of the supplier,
b)
designation and quantity of the medicinal product, including its batch name,
c)
the date of purchase;
2.
to submit a double or a copy of the prescription.
a)
Recipient name and address,
b)
Name and address of the prescribing veterinarian,
c)
Name and quantity of the medicine including its batch title,
d)
the date of delivery.
the extent that a prescription is required under section 4 (2) of the Ordinance on prescription of medicinal products shall not be presented in written or electronic form, shall be recorded at the time of the submission of the information provided for in the second sentence of the second sentence, also in conjunction with the fourth sentence of paragraph 2. Where, in the cases referred to in sentence 2 (1) (b) and (2) (c), the medicinal product is not placed on the market in batches and has a date of manufacture, it shall be indicated.(2) prescription-only medicinal products intended for use in animals used for the production of foodstuffs may only be made on a prescription that is submitted in two copies. The original of the prescription is intended for the animal keeper, the copy remains in the pharmacy. The original shall indicate the batch name of the medicinal product, unless it is placed on the market in batches and has a date of manufacture, it shall be indicated.The head of pharmacies shall, at least once a year, calculate the inputs and outputs of the medicinal products subject to medical prescription intended for use in animals against the existing stock of these medicinal products, and shall establish deviations. Non-official table of contents

§ 20 Information and advice

(1) The pharmacy manager must ensure, within the framework of the quality management system, that Patients and other customers, as well as the persons entitled to exercise the medicine, dentistry or veterinary medicine, are adequately informed and advised on medicinal products and medical devices subject to apothecary. The obligation to provide information and advice on medicinal products must be carried out by pharmacists at the pharmacy, and may be taken over by other members of the pharmacy's pharmaceutical staff, if the pharmacist has previously been informed. in writing. In doing so, he also has to define the cases in which a pharmacist is to be added to the pharmacy in principle.(1a) The provision of information and advice to patients and other customers shall not affect the treatment of persons entitled to exercise the medicinal product, dentistry or veterinary medicinal product. To the extent that medicinal products are released without prescription, the pharmacist shall provide the patient and other customers with the information necessary for the proper application.(2) Information and advice on medicinal products must take into account, in particular, aspects of the safety of medicinal products. The advice must include the necessary information on the appropriate use of the medicinal product, where necessary, including any adverse reactions or interactions resulting from the information provided on the prescription as well as the information provided on the information provided on the prescription. of the patient or of the customer, and on the proper storage or disposal of the medicinal product. In the case of the supply of medicinal products to a patient or other customer, it is also possible, by demand, to determine to what extent this need, if necessary, further information and advice requirements and to offer appropriate advice. In the case of self-medication, it is also possible to determine whether the desired product appears to be suitable for use in the intended person or in which cases it should be recommended to consult a doctor if necessary. The sentences 1 to 4 shall apply accordingly to medical devices subject to pharmacies.(3) The Head of Pharmacies shall provide relevant information in order to help patients and other customers to make an informed decision, including in relation to treatment options, availability, quality and safety of the services; it also provides clear invoices and clear pricing information, as well as information on the permit or permit status of the pharmacy, the insurance cover or other forms of personal or collective protection in relation to: his professional liability.(4) The head of a pharmacy or pharmacist responsible for the hospital is responsible for providing information and advice to doctors at the hospital on medicinal products and medical devices subject to pharmacotherapy. He's a member of the Hospital's Medicines Commission. Non-official table of contents

§ 21 Medicinal Products Risks, Treatment of Non-Transport Medicines

The Head of Pharmacist has to ensure that: the following measures shall be taken:
1.
All information about complaints about medicines, in particular drug risks such as quality and packaging defects, flaws of labelling and package leaflet, Adverse reactions, interactions with other medicinal products, contraindications and abusive use must be reported to him or his pharmacist immediately.
2.
He or the pharmacist he has commissioned has to verify the information and to take the necessary security measures.
3.
In the case of medicinal products or starting materials which have been obtained by the pharmacy, the acceptance of quality defects caused by the manufacturer is justified by the competent to notify the authority without delay.
4.
The competent authority shall be informed of the withdrawal of medicinal products manufactured in the pharmacy, indicating the reason for the withdrawal of medicinal products. immediately.
5.
About the drug risks identified in the pharmacy, as well as the subsequent assessments, measures and measures, and Notifications shall be recorded.
6.
In the case of hospital pharmacies, without prejudice to points 1 to 5, he has become aware of the number of pharmacies he has become aware of. to immediately inform the leading doctors and the hospital's Medicinal Products Commission.
7.
Medicinal products or starting materials that do not shall be able to rework, return, or destroy, unless immediately re-worked, returned or destroyed, they shall be identified as such and shall be identified as such and shall be identified as such; and shall be sent to the public. The measures are to be kept records.
8.
Counterfeit medicines found in the distribution network are up to the decision on the way forward. shall be kept separately from marketable medicinal products and secured in order to avoid confusion and to prevent unauthorised access. They must be clearly labelled as not intended for sale. The competent authority shall be immediately informed of the occurrence of counterfeit medicines. The measures taken are to be documented.
Medical products are subject to the Medical Devices Safety Planning Ordinance. Non-official table of contents

§ 22 General documentation

(1) All records relating to the manufacture, review, review of the medicinal products in the Hospital and facilities to be supplied within the meaning of § 12a of the pharmacies act, storage, importation, placing on the market, the recall, the return of the medicinal products on the basis of a recall, the certificates according to § 6 para. 3 sentence 2 and § 11 The first sentence of paragraph 2 and the evidence in accordance with § 19 shall be kept in full and at least one year after expiry of the expiry date, but not for less than five years. The original content of an entry must not be made unrecognizable. No changes may be made which do not indicate whether they have been made at or after the original registration.(1a) (omitted) (1b) Records in accordance with Article 17 (6), first sentence, No. 2, half sentence 2 shall be kept after the last registration for three years.(2) Recordings may also be made and stored on image or data carriers. In this case, it must be ensured that the data are available during the retention period and can be made legible within a reasonable period of time. In the case of a recording and storage exclusively on data carriers, a name character required under this Regulation shall be marked by an electronic signature according to the signature law and a personal signature by a qualified electronic signature in accordance with the signature law.(3) The records and evidence shall be submitted to the competent authority upon request.(4) By way of derogation from paragraph 1, the records in accordance with Section 17 (6a) shall be kept or stored and destroyed or deleted for at least thirty years if the storage or storage is no longer required. If the records are kept or stored for more than thirty years, they shall be anonymized. Non-official table of contents

§ 23 serviceability

(1) Pharmacies are committed to a permanent service. The competent authority shall exempt a part of the pharmacies from the duty to be ready for service in whole or in part at the following times:
1.
Mondays to sonnabends 0:00 Watch until 8:00 a.m.,
2.
Monday to Friday from 18:30 to 24:00,
3.
sonnabends 14:00 to 24:00,
4.
on 24. and 31. December from 14:00 to 24:00,
5.
on Sundays and on public holidays.
(2) The competent authority may be required to have a service. the duration of the normal closing times, Wednesday afternoons, sunnights or operating holidays and, if there is an justified reason, also outside these periods, if the supply of medicinal products during that period has been caused by another Pharmacy, which can also be located in another community, is ensured.(3) During the periods referred to in the second sentence of paragraph 1, it is sufficient to ensure that the head of the pharmacy or an authorised person is in the immediate vicinity of the pharmacy premises and at any time when the person is in a position to take up a service. can be reached. The competent authority may, in duly substantiated individual cases, free a pharmacist on request from the obligation set out in the first sentence if the head of pharmacies or a person entitled to represent a representative can be reached at any time and if the supply of medicinal products is available in a way that is reasonable for the customer.(5) For patients or other customers, a readily legible indication of the nearest pharmacies to be prepared should be affixed to pharmacies which are not ready for service.Without prejudice to the provisions of paragraphs 1 to 4, pharmacies supplying hospitals with medicinal products and medical devices subject to pharmacies shall, without prejudice to the provisions laid down in paragraphs 1 to 4, have a service provision scheme with the institution of the hospital which shall: to ensure proper hospital care and advice from a pharmacist at the pharmacy. Non-official table of contents

§ 24 Recipe collection points

(1) Bodies for collection of prescriptions (prescription collection points) may only be used with permission shall be maintained by the competent authority. Permission shall be granted to the holder of a pharmacy on request, if a reception office is required for the proper supply of medicinal products from remote places or districts without pharmacies. The permit shall be limited and shall not exceed the duration of three years. A repeated grant shall be permitted.(2) Recipe collection points shall not be entertained in commercial establishments or in the case of health professionals.(3) The prescriptions must be collected in a sealed container which is protected from access by unauthorised persons. The name and address of the pharmacy as well as the pick-up times must be clearly indicated on the container. In addition, on or immediately adjacent to the container, a clear indication shall be made of the fact that the prescription shall be made up by name, first name, place of residence, street and house number of the consignee and indicating whether the order has been picked up in the pharmacy or The receiver is to be provided. The container must be emptied or collected at the times indicated at the time by a messenger, who must belong to the staff of the pharmacy.(4) The medicinal products must be packaged separately in the pharmacy for each recipient and shall be provided with the name and address of each recipient. If they are not collected, they are to be delivered to the recipient in a reliable manner by way of messenger delivery in accordance with § 17 (2). unofficial table of contents

§ 25 (omitted)

- unofficial Table of Contents

§ 25a Abwehr of Threatening Communicable Diseases

In the event of a threatening communicable disease, the spread of which is an immediate and the usual measure of the provision of specific Article 11 (2) does not apply to raw materials used in the manufacture of medicinal products within the meaning of Article 21 (2) (c) of the German Medicines Act, provided that
1.
whose quality is proven by a test certificate in accordance with § 6 para. 3,
2.
the container is closed in such a way that an intermediate opening of the container would be visible and
3.
neither the container nor the closure are damaged.
If the container is operated in a Member State of the European Union or the European Union The economic area, which has an authorisation under Article 77 of Directive 2001 /83/EC, in accordance with national law, has been opened in unaltered form for the purpose of refilling or packaging the raw material, and finds Article 11 (2) no application if the pharmacy has a copy of the test certificate in accordance with section 6 (3) and a written confirmation of the holding that, when the vessel is opened, the conditions laid down in the first sentence of the first sentence of 1 to 3 and the starting materials are in place in suitable containers have been refilled or packed. In the case of a threatening communicable disease, the spread of which requires an immediate and a normal level of delivery of specific medicinal products, Article 17 (1) shall not be applied to medicinal products which are be made available to the competent federal or state authorities.

Third section
The operation of hospital pharmacies

unofficial table of contents

§ 26 applicable rules

(1) The hospital pharmacist is the functional unit of a hospital that ensures the proper care of one or more hospitals with medicinal products and medical products subject to pharmacies, as well as information and advice on these products, in particular doctors, nursing staff and patients.(2) The provisions of § § 1a and 2a as well as § § 4a, 5 to 8 and 11 to 14, 16, 17 (1) and (6c), § § 18, 20 (1) and § § 21, 22 and 25a shall apply accordingly for the operation of hospital pharmacies. Non-official table of contents

§ 27 Head of hospital pharmacy

(1) Pharmacy leader is the one employed by the hospital institution and with the Management instructed pharmacists.(2) The head of the hospital pharmacist is responsible for ensuring that the pharmacy is operated in compliance with the applicable regulations. In particular, it has to ensure that
1.
supplies the ordered medicines and pharmacy-based medical devices as needed and medicinal products that are available to acute medical care is urgently needed, immediately available,
2.
the medicine stored in the hospital, and Medical devices subject to pharmacies are regularly checked and the checks are documented,
3.
a pharmacist at the pharmacy
a)
the hospital's staff with a view to safe, convenient and cost-effective drug therapy and use of medicines or pharmacovigilant medical devices and
b)
where necessary, the patient with a view to ensuring a safe use of medicinal products, in particular in connection with his dismissal from the Hospital
.
The head of hospital pharmacies is a member of the hospital's pharmaceutical commission.(3) The head of the hospital pharmacist can only be represented by a pharmacist. During the period of representation, the Office shall be responsible for the duties of the pharmacist.(4) The provisions of section 2 (3) and (5) shall apply accordingly. Non-official table of contents

§ 28 Hospital hospital staff

(1) The necessary for the proper operation of the hospital pharmacy Personnel, in particular the pharmaceutical personnel, must be present in sufficient numbers. The staffing requirements result from the type and extent of a medically expedient and adequate supply of the hospital with medicinal products and medical devices subject to apothecary, taking into account the size, type and performance structure of the medical device. Hospital. The second sentence shall apply in so far as the hospital pharmacist also provides care for other hospitals.(2) The head of the hospital pharmacy is responsible for the use of the pharmacist.(3) The provisions of § 3 (1), (5) and (6) shall apply accordingly. Non-official table of contents

§ 29 Spaces and establishment of the hospital pharmacist

(1) The health care service for the hospital pharmacies necessary spaces must be present. In this connection, the type, nature, size and number of rooms, as well as the establishment of the hospital pharmacy, must be aligned with the standards of § 28 (1) sentence 2.(2) The hospital pharmacy shall consist of at least one officer, two laboratories, one business area and one side room, and shall have sufficient storage space; in a laboratory, a withdrawal shall be provided with a suction device. Storage below a temperature of 25 degrees Celsius must be possible. The total area of these operating rooms must be at least 200 square metres. The provisions of § 4 (1) sentence 1, 2 (1) to (4), third sentence, (2) sentence 4, (2b), (2d), (2d), (4), third sentence, and (6) shall apply accordingly.(3) The type and number of equipment for the manufacture, testing and determination of starting materials and medicinal products as well as the type and number of test equipment shall be based on the size, type and performance structure of the hospital. The provisions of Section 4 (7) and (8) shall apply. Non-official table of contents

§ 30 Prefrath in the hospital pharmacist

The guarantee of proper care for patients Hospitals and medical devices required for pharmacies must be kept in stock in sufficient quantities, which must be at least equal to the average requirement for two weeks. These medicinal products and medicinal products subject to pharmacotherapy are to be listed. Non-official table of contents

§ 31 levy in the hospital pharmacy

(1) Medicinal products and medical devices subject to apothecary may be used at stations or Other sub-units of the hospital shall be issued only on the basis of a prescription in individual cases or on the basis of a written request. This shall apply in accordance with prescriptions or requirements in electronic form.(2) In the case of the delivery to stations and other sub-units of the hospital, the medicinal products and medical devices subject to pharmacies shall be protected from the access of unauthorized persons. They shall be delivered in a suitable sealed container on which the pharmacy and the consignee are to be indicated. Partial quantities of ready-to-use medicinal products to be handed out to patients in connection with pre-or post-hospital treatment or an outpatient operation for use outside the hospital shall be subject to the conditions laid down in section 14 (1) A package leaflet shall be marked and provided with a package leaflet.(3) Medicinal products derived from a pack intended for sale to the consumer may be dispensed without an outer packaging only if the name of the medicinal product, the name of the batch and, where appropriate for the medicinal product, the name of the medicinal product on the container. required, the expiry date and the retention instructions are indicated and the package leaflet is added.(4) The provisions of Article 17 (1), (1a), (4), (5), (1) (1) to (3), and the second and third sentences of paragraphs (2) and (3) and (6c) shall apply muta Non-official table of contents

§ 32 Review of the stocks of medicinal products and medical devices subject to pharmacies on the stations

(1) Obligation of the head of the hospital pharmacy or of a pharmacist who is responsible for checking the stocks of medicinal products in accordance with § 14 (6) of the law on pharmacy extends to all the stations and to the pharmacists 'pharmacists' , the review of the stocks of medicinal products must be carried out at least half-yearly. The first sentence shall apply to medical devices subject to apothecary requirements.(2) The checking pharmacist and the pharmacist supporting him shall be entitled to enter the premises used for the supply of medicinal products. The hospital management and the rest of the hospital staff shall support the conduct of the review.(3) The head of the hospital pharmacy or the pharmacist of the pharmacy responsible for the pharmacy has to make a protocol in four copies of each inspection. The log must contain at least
1.
the date of the review,
2.
the name of the station or the other subunit of the hospital,
3.
the name of the pharmacist and the other persons involved in the review,
4.
the nature and scope of the review, in particular with regard to
a)
the general storage and retention conditions,
b)
the storage and storage of medicines and medical devices according to the recognized pharmaceutical rules,
c)
the composition including the medicines and medical devices,
d)
the Fail data
5.
the identified defects,
6.
to eliminate the defects. assessed measures,
7.
the deadline set for the elimination of defects,
8.
on the elimination of previously identified defects,
9.
the signature with the date of the pharmacist responsible for the inspection.
A copy of the Minutes shall be assigned to the hospital management at the latest four weeks, in the event of serious defects immediately after the inspection has been carried out, in each case one additional person shall be handed out to the physician and to the care service, who shall be responsible for the The supply of medicinal products to the station or to the other subunit of the hospital and the fourth is to be kept in the pharmacy. Non-official table of contents

§ 33 Readiness to service the hospital pharmacist

One of the hospital's proper medical care The holder of the permit shall ensure that the service is ready for service. This also implies that advice is provided by a pharmacist at the pharmacy.

Fourth Section
Special Regulations

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§ 34 Patient-specific bodies or the blister of medicinal products

(1) In the quality management system according to § 2a, the following provisions shall be made in particular: meet:
1.
for the selection of medicinal products that are in principle eligible for a job or a new remaining product or which are not available for the job or the
2.
to decide which medicinal products may not be stored in the same single container for simultaneous administration, or in the same single blister,
3.
for a decision in which exceptional cases of a written medical request concerning a prior to the job, or Remaining division of tablets, if otherwise the supply cannot be secured and, in the case of proven validation of the stability of its quality, over the shelf life of the blister or the reusable If necessary, although the subsequent modification of the finished product should in principle be prevented,
4.
for interim storage and labelling of the bleed medicinal products,
5.
on technical and organisational measures to maintain the quality of the medicines that have been unleaned and to ensure that avoid, in particular, cross-contamination and confusion, including verification of their effectiveness,
6.
for calibration, qualification, maintenance, and Cleaning of the blister machines, as far as used, or other critical equipment or equipment,
7.
to the primary packaging materials and their Quality checks,
8.
to the manufacturing instructions and to the production logs according to § 7,
9.
to the hygiene plan as well as
10.
to the hygienic behavior of the staff at the workplace and to the type of Protective clothing for the manufacture of medicinal products, including the manner and frequency of changing operations.
(2) The staff must be sufficiently qualified to carry out the activities and be trained on a regular basis; Training measures must be documented. The staff required for the first sentence of Article 3 (2) shall be obtained from the scope of manufacture.(3) By way of derogation from § 4 (2b), the patient-specific body or the blister shall be made in a separate room, which shall be used exclusively for this purpose. The space must be of an appropriate size in order to be able to carry out the individual operations in specifically assigned areas. Its walls and surfaces, as well as the floor, must be easy to clean, so that the risk of contamination of the medicinal products due to the environment is minimal. The access and the introduction of the materials should take place, at least in the case of machine blistering, via a space (lock) for maintaining a room quality suitable in the production space. § 4a shall apply accordingly. A derogation from the first sentence of the first sentence and the fourth sentence may be waived if, in exceptional circumstances, the body or the manual sublimation of medicinal products is to be carried out for a single patient.(4) The following information must be derived from the labelling of the newly packaged medicinal product:
1.
the name of the patient,
2.
the included medicines and their batch designations,
3.
the expiration date of the new and its batch name,
4.
the take-in notes,
5.
Possible storage hints as well as
6.
the dispensing pharmacy and, if different, of the Manufacturers.
The newly packaged medicinal product must be accompanied by the package leaflets of the pre-packaged medicinal products in accordance with Section 11 (7) of the Medicines Act. Non-official table of contents

§ 35 Manufacture of medicinal products for parenteral use

(1) In the quality management system according to § 2a, in particular: See
1.
for the medicines to be used, as well as the primary packaging materials and their quality checks,
2.
to the technical and organizational measures to avoid contamination, cross-contamination and confusion, including the review of their Effectiveness,
3.
for calibration, qualification, maintenance, and cleaning of equipment and manufacturing space,
4.
to validate the processes, methods and systems influencing product quality, and to revalidate; for aseptic manufacturing processes at the end of each working day, Inclusion of the manufacturing personnel concerned,
5.
on critical equipment or devices,
6.
to the manufacturing instructions and manufacturing protocols according to § 7 or § 8,
7.
to a possible Transport of the manufactured medicinal products,
8.
to the hygiene measures as well as
9.
to the hygienic behaviour of the staff at the workplace and the type of protective clothing for the manufacture of medicinal products, including the manner and frequency of the changing operations.
(2) The staff must be sufficient to carry out the activities be qualified and trained on a regular basis; the training measures must be documented. The staff required pursuant to Article 3 (2), first sentence, shall be obtained from the type and extent of manufacture.(3) The manufacture of parenteral medicinal products shall be carried out in a separate room which may not be used for other activities, except for the manufacture of other sterile preparations according to the pharmacopoeia. Access to this space as well as the introduction of materials must take place via an intermediate space (lock), which is suitable for maintaining the clean room classes required in the production area. The space must be used solely for the purpose of producing parenteral medicinal products, of appropriate size, in order to be able to carry out the individual operations in specifically assigned areas, and ventilation must be more appropriate via filters. Efficacy shall be carried out. Its walls and surfaces, as well as the floor, must be easy to clean, so that the risk of contamination of the medicinal products due to the environment is minimal. In the room at the time of manufacture, only employees who carry out activities there may be present; their protective clothing must be adapted to the activities and must be changed at least in the working day. § 4a shall apply accordingly.(4) Insofar as the medicinal products are not subjected to a sterilisation process in the final container and they are not produced in the closed system, during preparation and filling,
1.
in the local area for the operations, an air purity level for the number of bacteria and the number of particles corresponding to Class A of the definition of the EC-GMP guide, Annex 1, of the Federal Ministry of the Federal Gazette (Bundesanzeiger) in the current version is made known, to be followed and
2.
a suitable environment required in relation to Particle and seed count
a)
at least equal to Class B of the Appendix of the guide
b)
or deviating from Class B at least of Class C of the Appendix of the Guide, if the quality of the medicinal product is demonstrably guaranteed by the method used and by appropriate validation of the method,
c)
or when using an isolator of class D of the Appendix of the guide
For the preparation of medicinal products which are not produced in the closed system but which are subjected to a sterilisation process in the final container, an environment shall, by way of derogation from the first sentence of point 2, point (a) in respect of the number of particles and germs of at least Class D of the Annex to the Guide; for the bottling of these medicinal products, a degree of air purity of class C shall be complied with.(5) Clean room conditions must be checked by means of appropriate controls on the air, critical surfaces and the personnel on the basis of particle and germ count determinates during the production in open systems. The pharmacists responsible for the release procedure must set appropriate warning and action limits for this.(6) § § 6 to 8 shall apply to the manufacture of parenteral medicinal products. The plausibility check of the medical prescription must also include, in particular, patient-specific factors, as well as the control dosage and the individual dose possibly resulting therefrom. The manufacturing instruction must also check the calculations, the weighing and the starting materials to be used by a second person, or by validated electronic procedures, and a leak test of the container filled in. . Non-official table of contents

§ § 35a u. 35b (omitted)

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Fifth section
Administrative Offences, Transitions and Final Provisions

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§ 36 Administrative Offences

is an administrative offence within the meaning of Section 25 (2) of the law on pharmacy, who deliberately or negligently
1.
contrary to § 3 paragraph 5 sentence 1 in conjunction with sentence 2 pharmaceutical activities
1a.
contrary to § 17, paragraph 1a, sentence 1, a medicinal product,
1b.
contrary to § 2
2.
as Head of Pharmacy
a)
a regulation of § 2 para. 5 or 6 sentence 1, 2 or 3 on the representation of the pharmacist
b)
contrary to § 2a, paragraph 1, sentence 1, a quality management system does not operate a quality management system,
c)
contrary to § 3 paragraph 5 sentence 1 in conjunction with § 2 para. 2 sentence 2 and 3 or § 3 para. 5 sentence 2 pharmaceutical activities can be carried out,
d)
contrary to § 3 para. 5 sentence 3 in conjunction with § 2 para. 2 sentence 2 and 3 pharmaceutical activities not supervised or not supervised by a pharmacist
e)
contrary to § 15, paragraph 1, sentence 2, does not hold a medicinal product referred to there,
f)
contrary to § 15, paragraph 2, it does not ensure that a medicine referred to there can be held in stock or can be procured in the short term,
g)
contrary to § 17 para. 1a sentence 1 medicinal product outside of the pharmacy premises or contrary to § 17 para. 3 pharmacy-subject medicinal products by way of self-service to the market ,
h)
in conjunction with § 31 (1) sentence 1 or paragraph 3, also in connection with § 2 para. 2 sentence 2 and 3, releases or surrender of medicinal products ,
i)
in conjunction with section 32 (1) and with § 2 para. 2 sentence 2 and 3 on the stations or in other subunits of the hospital in stock shall not be checked in full or in a timely manner or checked by a pharmacist or, contrary to § 17 (7) in conjunction with section 32 (3) and with § 2 (2) sentence 2, the prescribed protocol shall not be verified, not either correctly or not entirely, not to the hospital management, not to the doctor responsible or not to be kept or not to be carried out by a pharmacist,
j)
contrary to § 21, it does not ensure that the measures referred to there are taken in the case of drug risks or non-marketable medicinal products,
k)
contrary to § 23 para. 1, the pharmacy is not ready for service,
l)
contrary to § 23 para. 5 in conjunction with § 2 2 (2) and 3 (3) in a visible place, do not apply a legible notice to the nearest pharmacies, or cannot be brought in,
m)
§ 24 para. 1 sentence 1 a prescription office without the required permission to maintain,
3.
as a pharmacist or a member of the pharmaceutical staff
a)
(omitted)
b)
contrary to § 7 para. 1 sentence 1 medicinal product not produced in accordance with the prescription or contrary to § 7 para. 1 sentence 2 in the manufacture of other products other than those mentioned in the prescription Components without the consent of the presenter used,
c)
(omitted)
d)
§ 14 para. 1 medicinal product without the prescribed labelling,
e)
contrary to § 16 (1) sentence 1 or second sentence 2, a medicinal product, a starting material or a Medical device not stored correctly or not in the prescribed way,
f)
(dropped)
g)
(omitted)
h)
contrary to § 18 para. 1 sentence 1 on the prescription of medicines the prescribed Disclosures,
i)
contrary to the first sentence of Article 19 (1), do not carry out the evidence required there or, contrary to the first sentence of Article 19 (2), sentence 1 of the medicinal products referred to therein. , without a prescribtion in two copies,
j)
Records, certificates or evidence not corresponding to § 22 (1) sentence 1 Retained or contrary to § 22 para. 1 sentence 2 or 3 records, certificates or evidence unrecognizable or underwriting changes,
k)
contrary to § 22 (4) Record 1 does not retain a record, or not, or not, for at least thirty years, or stores it, or stores it not at least thirty years,
4.
as the director of a Hospital pharmacist
a)
contrary to § 26 (2) in conjunction with § 21, not to ensure that the
b)
contrary to § 28 (3) in conjunction with § 3 (5) sentence 1 and with § 27 para. 2 sentence 1 pharmaceutical activities can be carried out,
c)
contrary to § 28 (3) in conjunction with § 3 para. 5 sentence 3 and with § 27 para. 2 sentence 1 pharmaceutical
d)
contrary to the first sentence of Article 31 (1), (3) or (4) in conjunction with § 17 (5) sentence 1, in connection with § 27 (2) sentence 1, medicinal product, or
e)
contrary to § 32 (1) in conjunction with § 27 (2) sentence 1 on the stations or in other sub-units of the hospital not to be checked in full or not in good time or to be checked by a pharmacist or in accordance with § 32 (3) in conjunction with section 27 (2) sentence 1 of the shall not be carried out, not properly or not fully prepared, not sent to the hospital, shall not be handed over to the competent doctor or not kept, or shall not be carried out by a pharmacist
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§ 37 Transitional rules

(1) On pharmacies, for which prior to the 11. § § 2a, 4 (1) sentence 2 (1) (a), § 34 (3) sentence 1 and 4 as well as § 35 (3) sentence 2 shall not be granted until 1 June 2012. However, until this date, the rooms must continue to be used until 11 June 2014. June 2012.(2) At pharmacies, for which before the 11. Article 35 (5) of the German Pharmacies Act (Pharmacy Act) has been granted in connection with § 2 (4) of the German Pharmacies Act (Pharmacy Act) in June 2012. Until this date, the cleanroom requirements must be proven to meet at least the requirements of class A for the local zone and the class C for the ambient environment. unofficial table of contents

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