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

Unofficial table of contents

ApBetrO

Date of completion: 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 March 2015 (BGBl I). 278).

Status:	New by Bek. v. 26.9.1995 I 1195;
	Last amended by Art. 2a V v. 6.3.2015 I 278

For more details, please refer to the menu under Notes

Footnote

(+ + + Text evidence from: 1.7.1987 + + +)
(+ + + Changes due to EinigVtr cf. § § 2, 3, 17 and 35 + + +) Unofficial table of contents

Content Summary

First section
	General provision
§ 1		Scope
§ 1a		Definitions
Second section
	The operation of public pharmacies
§ 2		Pharmacist
§ 2a		Quality management system
§ 3		Pharmacies
§ 4		Nature, size and furnishing of the pharmacy premises
Section 4a		Hygiene measures
§ 5		Scientific and other tools
§ 6		General rules on production and testing
§ 7		Medicinal products for medicinal products
§ 8		Medicinal products for defectturation
§ 9		(dropped)
§ 10		(dropped)
§ 11		Starting materials
§ 11a		Activities on behalf of
§ 12		Testing of pharmaceutical products not manufactured in pharmacy and medical devices subject to pharmacies
§ 13		Containers
§ 14		Marking
§ 15		Stock option
§ 16		Storage
§ 17		Purchase and supply of medicinal products and medical devices
§ 18		Importation of medicinal products
§ 19		Purchase and supply of veterinary medicinal products subject to medical prescription
§ 20		Information and advice
Section 21		Drug risk, treatment of non-marketable medicines
Section 22		General documentation
Section 23		Serviceability
§ 24		Recipe collection points
Section 25		(dropped)
Third Section
	The operation of hospital pharmacies
Section 26		Rules to be applied
§ 27		Head of the hospital pharmacy
§ 28		Staff of the hospital pharmacy
§ 29		Rooms and furnishings of the hospital pharmacy
§ 30		Storage in the hospital pharmacy
Section 31		Levy in the hospital pharmacy
Section 32		Review of pharmaceutical stocks and medical devices subject to pharmacovigilanship at the stations
§ 33		Service of the hospital pharmacy
Fourth Section
	Special provisions
Section 34		Patients ' individual positions or the blister of medicinal products
§ 35		Manufacture of medicinal products for parenteral use
Fifth Section
	Procedural offences, transitional and final provisions
§ 36		Irregularities
Section 37		Transitional provisions
§ 35a		(dropped)
§ 36		(dropped)
Section 37		(dropped)

First section
General provision

Unofficial 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 lay down how to ensure the proper supply of medicinal products to the population and to medical devices subject to pharmacies. (2) This Regulation shall not apply to pharmacy operations in so far as a Permission under § 13, § 52a or § 72 of the Medicines Act has been granted. (3) The Medical Devices Operating Regulation as amended by the Notice of 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. Unofficial table of contents

§ 1a Definitions

(1) Hospital-supplying pharmacies are public pharmacies which provide hospital services in accordance with Article 14 (4) of the Law on Pharmacy. (2) Pharmaceutical staff are pharmacists, pharmaceutical-technical assistants, Pharmacists ' assistants, pharmacy assistants, pharmacy assistants, pharmaceutical assistants and persons who are in the training of pharmacists or the profession of pharmacotechnical assistant. (3) Pharmaceutical activity in the For the purposes of this Regulation:

1.

the development and manufacture of medicinal products;

2.

the testing of starting materials or medicinal products;

3.

the supply of medicinal products;

4.

information and advice on medicinal products,

5.

the review of medicinal products as well as the observation, collection and evaluation of drug risks and medication errors in hospitals or in hospitals according to § 14 paragraph 8 of the pharmacy law with regard to the supply of medicinal products Equivalent facilities or in the facilities to be supplied within the meaning of Section 12a of the Pharmacies Act,

6.

Medication management, with which the entire medication of the patient, including self-medication, is repeatedly analyzed with the goals of improving the drug therapy safety and the therapy remorse by using drug-related Problems are detected and solved.

(4) Patient-specific points are the manual re-packaging of ready-to-use medicaments, which is carried out on a single request and related to the patient, in a reusable container for certain times of acceptance of the patient. (5) Individual remaining patient-specific and patient-related manual or mechanical re-packaging of ready-to-use medicaments for specific patient-taking-time points of the patient in a non-reusable Container. (6) Starting material is each in the manufacture of a medicinal product (7) Primary packaging materials are containers or envelopes which come into contact with the medicinal products. (8) Medicinal products for prescription shall be a medicinal product which shall be used in accordance with the procedure referred to in Article 1 (2). the pharmacy is produced on a case-by-case basis on the basis of a prescription or other requirement of a single person and not in advance. (9) The medicinal product for defective products is a medicinal product which is available in advance as part of the normal operation of the pharmacy. one day in up to one hundred packings ready for delivery or in one of these (10) Pharmacy common goods are:

1.

Medicinal products not subject to the obligation to pharmacies,

2.

Means, as well as objects and information carriers, which directly serve or promote the health of humans and animals,

3.

means of personal care,

4.

Test equipment,

5.

chemicals,

6.

reagents,

7.

Laboratory requirements,

8.

pesticide and plant protection products, and

9.

Means for the rearing of animals.

(11) The usual pharmacy services are services that serve or promote the health of humans or animals, in particular:

1.

the consultation

a)

in health and nutrition,

b)

in the field of health education and education,

c)

on preventive measures,

d)

on medical devices,

2.

the implementation of simple health tests,

3.

The patient-specific adaptation of medical devices as well as

4.

the provision of health-related information.

(12) Inprocess controls shall be 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 product is of the expected quality; in the manufacture of sterile medicinal products, 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 containing the starting materials or medicines in contact or another major influence 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 obtained by means of a measuring instrument or a measuring instrument, and the other, the following: measuring system, or the values resulting from a material measurement and on the other hand the corresponding values of a reference standard. (15) Qualification is the provision of a documented proof, which with high security Shows that a specific item of equipment or a specific item of equipment The environmental condition for the manufacture or testing of the medicinal product corresponds to the previously defined quality characteristics. (16) Validation is the provision of a documented proof that proves with high certainty that a specific product is required to produce a (17) Production in the closed system is the transfer of sterile starting materials or solutions in the form of a product or a standard working method. a pre-sterilized closed container, without the contents comes into contact with the outside environment.

Second section
The operation of public pharmacies

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§ 2 Head of Pharmacy

(1) Pharmacy manager is

1.

in the case of a pharmacy which is operated in accordance with Article 1 (2) of the law on pharmacy, the holder of the licence pursuant to section 2 of the pharmacy law, in the case of leasing, the tenants,

2.

in the case of a pharmacy or a two-gas pharmacy, administered in accordance with section 13 or section 16 of the law on pharmacy, the holder of the authorisation,

3.

in the case of a pharmacy which is operated in accordance with Article 17 of the law on pharmacy, the pharmacist appointed by the competent authority and instructed by the management,

4.

in the case of a main mortgage pursuant to § 2 para. 5 no. 1 of the pharmacy law, the holders of the licence pursuant to § 2 para. 4 of the Pharmacy Act,

5.

in the case of a branch pharmacy pursuant to section 2 (5) (2) of the pharmacy law, the controller named by the operator.

(2) The pharmacist shall 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. (3) The head of pharmacies shall have any other professional or professional activity to the competent authority. (4) The Head of Pharmacies shall, in addition to medicinal products and medicinal products subject to pharmacies, offer the goods referred to in Article 1a (10) only to a degree or to a degree to which the proper operation is carried out. the pharmacy and the priority of the supply of medicinal products not impaired. The first sentence must be applied in accordance with the standard services provided for in Article 1a (11) of the pharmacy. (5) The head of pharmacies must, if he/she temporarily does not fulfil his obligation to manage the pharmacy in his own right, by means of a Pharmacists can be represented. 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 not be able to: He shall be represented by a pharmacist or pharmacist, provided that he is suitable, in particular, with regard to his/her knowledge and skills and, in the course of a period of at least six months prior to the start of representation, in the course of his or her career in of a public pharmacy or hospital pharmacy. 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 rates 1 to 3 shall not apply to the representation

1.

the holder of a permit pursuant to Section 2 (4) of the Pharmacy Act,

2.

of the head of a pharmacy providing hospital care, and

3.

The head of a pharmacy to which the special provisions of § 34 or § 35 apply.

(7) During the period of representation, the pharmacist or pharmacist assistant or pharmacist assistant responsible for the representation shall be responsible for the duties of a pharmacist. Unofficial table of contents

§ 2a Quality management system

(1) The Head of Pharmacies shall operate a quality management system according to the nature and extent of the 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 any confusion is avoided and that sufficient advisory services are provided. (2) In the framework of the Quality Management System, the Head of Pharmacies shall ensure that self-inspection by pharmaceutical personnel is carried out on a regular basis in order to check the operational procedures and, if necessary, Corrections are made. In addition, the pharmacy should take part in regular external quality audits. (3) The head of the pharmacy is responsible for ensuring that the verifications and the self-inspections referred to in paragraph 2, as well as the subsequent checks and inspections, are carried out. if necessary, the measures taken are documented. Unofficial table of contents

§ 3 Pharmacy staff

(1) Pharmacy personnel may only be used in accordance with their training and knowledge and must be regularly informed of the care provided in the course of their activities. 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 products, the Pharmacy must be sufficient to provide the necessary personnel, in particular the pharmaceutical personnel, 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 mutatily to the supply of facilities within the meaning of Section 12a of the Pharmacy 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 pharmacies or supervised by a pharmacist. Pharmaceutical assistants may not release any medicinal products. (5a) The refilling, including filling 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, pharmacies, pharmaceutical and commercial employees, as well as persons who are in training as a profession of pharmacomarketing employee. In addition, the pharmaceutical staff may be supported by the other staff of the pharmacy referred to in sentence 1.

1.

in the manufacture and testing of medicinal products,

2.

in the examination of the starting materials,

3.

by the operation, maintenance and maintenance of the work equipment,

4.

during the filling and packaging or marking of the medicinal products, and

5.

in the preparation of the medicinal products for delivery.

The staff employed in the manufacture of the first sentence or the assistance referred to in the second sentence shall be suitably qualified to perform these tasks and shall be shown to have taken due diligence in the course of their activities at the beginning and thereafter on a continuous basis. (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 holding. 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. Unofficial table of contents

§ 4 Nature, size and furnishing of the pharmacy premises

(1) The operating rooms must be suitable in accordance with the type, size, number, position and equipment, proper pharmacy operation, in particular the proper development, manufacture, testing, storage, packaging and proper delivery of To ensure that medicinal products or medical devices are to be provided and provided with 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)

of premises which are otherwise commercially or professionally used, including 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 traffic areas and shopping streets,

2.

protect against unauthorised access by appropriate measures,

3.

sufficiently to illuminate and ventilate and, if necessary, to air-conditioned,

4.

in a flawless construction and hygienic condition, and

5.

in such a way that each room can be reached without leaving the pharmacy (room unit).

The first subparagraph of point 1 (a) shall not apply to the manufacture of medicinal products for which a licence is required in accordance with Article 13 of the Medicines Act. (2) The pharmacy must at least be made from an officer, a laboratory, a sufficient storage space and of 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 to pharmacies providing hospital care. (2a) The Offizin must have access to public transport areas and should be accessible in a barrier-free manner. 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 (2b) For the manufacture of medicinal products which are not intended for parenteral use, provision should be made for their own place of work. 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 of the medicinal products 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) For the manufacture of medicinal products which are drugs or mixtures of drugs, or for the manufacture of medicinal products for the manufacture of medicinal products or pharmacies. other processing of drugs as starting materials must be provided with a separate workplace. The second sentence of the second sentence of paragraph 2b shall not apply. (2d) The storage room shall be sufficiently large and allow for the proper storage of products held or sold in stock in the pharmacy. It must be possible to store storage below a temperature of 25 degrees Celsius. 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 at least be made up of an officer, sufficient storage space 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 apply to:

1.

storage rooms intended solely for the supply of medicinal products to hospitals or for supplying residents of facilities to be supplied within the meaning of Section 12a of the Pharmacies Act;

2.

spaces relating to mail-order trade, including electronic trade in medicinal products, as well as to 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 in close proximity to the other premises. 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 Pharmacy Act is not permitted. (5) (omitted) (6) Essential changes in size and location (7) The pharmacy must be equipped with equipment in such a way that medicinal products, in particular in the forms of administration, must be provided with:

1.

solutions, emulsions, suspensions,

2.

Ointments, creams, gels, pastes,

3.

capsules, powder,

4.

Drug mixtures and

5.

Pawls 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. As far as there is no device for the production of water for injections, water must be kept in sufficient quantity for injection as a ready-to-use product. (8) In the pharmacy, equipment and test equipment shall be used for the examination of the Pharmacies and their starting materials are available in accordance with the recognised pharmaceutical rules. Unofficial table of contents

§ 4a Hygiene measures

The Head of Pharmacies shall take appropriate hygiene measures to ensure the microbiological quality of the medicinal product concerned, for the staff and the premises used for the manufacture of medicinal products. In particular, the following shall be laid down for the hygiene measures:

1.

the frequency and type of cleaning of the manufacturing areas or premises;

2.

where necessary, the frequency of disinfection of the manufacturing and manufacturing areas, and

3.

the means and equipment to be used.

The measures shall be laid down in a hygiene 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. Unofficial table of contents

§ 5 Scientific and other tools

In the pharmacy must be present

1.

scientific aids necessary for the manufacture and testing of medicinal products and raw materials in accordance with the recognised pharmaceutical rules in the course of pharmacies, in particular the pharmacopoeia;

2.

scientific means necessary for the provision of information and advice to the customer on medicinal products;

3.

scientific means necessary for the provision of information and advice on medicinal products authorised for the exercise of medicine, dentistry or veterinary medicinal products,

4.

Texts of the legislation applicable to pharmacies.

The scientific and other aids must be kept up-to-date and may also be available on electronic media. Unofficial table of contents

Section 6 General provisions on production 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 shall 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 test shall be repeated in reasonable periods of time. (2) For the manufacture of medicinal products, provision should be made for mutual adverse effects on medicinal products and for confiscations of medicinal products; and (3) The examination of the medicinal products may be carried out under the responsibility of the pharmacist outside the pharmacy:

1.

in an establishment for which permission is granted in accordance with Section 13 of the Pharmaceutical Act,

2.

in an establishment in a Member State of the European Union or of the European Economic Area, for which, in accordance with national law, a permit has been granted in accordance with Article 40 of Directive 2001 /83/EC of the European Parliament and of the Council of 6 June 2001, November 2001 on the Community code relating to medicinal products for human use (OJ C 327, 28.11.2001, 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 November 2001 on the Community code relating to veterinary medicinal products (OJ L 327, 22.12.2001, p. 1), as last amended by Regulation (EC) No 596/2009 (OJ L 311, 28.11.2009, p. 14), which is in force in the current version,

3.

in an establishment for which permission is granted in accordance with § 1 (2) in conjunction with Section 2 of the Pharmacy Act, or

4.

by an expert within the meaning of Section 65 (4) of the Medicines Act.

The person responsible for the inspection of the holding or the person referred to in point 4 of the first sentence shall certify that the medicinal product is tested in accordance with the recognised pharmaceutical rules, stating the batch and the date and the results of the test. has been and has the quality required (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; records must be made of the tests carried out. (4) The provisions of the Medical Devices Act on the production, special production and production of own products of medical devices is unaffected. Unofficial table of contents

§ 7 Medicinal Products For Prescription

(1) If a medicinal product is manufactured on the basis of a prescription of persons entitled to the exercise of the medicine, dentistry or veterinary medicine, it shall be in accordance with the prescription. 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 a prescription, the sentence 4 shall be applied accordingly. (1a) A medicinal product for prescription shall be prepared in accordance with a written production instruction previously prepared by a pharmacist or, in the case of a representative, in accordance with Article 2 (6). is to be signed by the person authorized to represent the pharmacy. The manufacturing instruction must be at least fixed

1.

for the production of the respective pharmaceutical form, including manufacturing technology and equipment,

2.

for the plausibility check referred to in paragraph 1b,

3.

on primary packaging materials and on labelling,

4.

on Inc-processing controls, where feasible,

5.

to prepare the workplace and

6.

for release and documentation.

In the case of standardized and general third-party manufacturing instructions, they must be adapted to the respective pharmacy establishment. (1b) The requirement for the manufacture of a prescription drug is by a pharmacist in accordance with Assess pharmaceutical aspects (plausibility check). The plausibility check shall in particular take account of:

1.

the dose,

2.

the mode of application,

3.

the nature, quantity and compatibility of the starting materials and their consistent quality in the ready-made formulation medicinal product, over the shelf life of the products, and

4.

the shelf life of the prescription drug.

The plausibility check is to be documented by a pharmacist or in the case of representation pursuant to § 2 (6) of the person entitled to represent the person. (1c) The preparation of the medicinal product for prescription shall be documented by the producing person. (production protocol) and shall include in particular:

1.

the nature and quantity of the 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.

the name of the patient and the prescribing physician or dentist,

5.

in the case of medicinal products for use in animals, the name of the keeper and animal species and the name of the prescribing veterinarian;

6.

in the case of prescription drugs produced on the customer's request, the name of the customer and

7.

the name of the person who produced the prescription drug.

In place of the name of the patient, keeper or customer in accordance with sentence 1, number 4, 5 or 6, a reference production number can also 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 carried out before delivery to the patient. (2) In the case of a prescription drug, an analytical examination may be carried out, provided that the quality of the medicinal product by the manufacturing process, the organoleptic examination of the product, is not possible. ready-made medicinal products and, where provided for, the results of the in-process controls. Unofficial table of contents

§ 8 Products for defecturation

(1) A defecturist shall be prepared in accordance with a previously prepared written production instruction, to be signed by a pharmacist at the pharmacy. In particular, the production statement must be made with the following provisions:

1.

to the starting materials to be used, the primary packaging materials and equipment,

2.

on the technical and organisational measures to avoid cross-contamination and confusion, including the preparation of the workplace;

3.

for the determination of the individual work steps, including the set values, and where feasible, of in-process controls,

4.

the labelling, including the date of manufacture and the date of decay or verification, and, where necessary, on storage conditions and precautions, and

5.

for release to the market within the meaning of Section 4 (17) of the Medicines Act.

(2) Production shall be documented in accordance with the manufacturing instruction at the time of manufacture by the person making the manufacture (the manufacturing protocol); the content of the Protocol must be based on all the important activities relating to the manufacture of such products. to be traced back. The manufacturing protocol shall indicate the basic manufacturing instruction and shall include in particular:

1.

the date of manufacture and the batch name,

2.

the starting materials used and their weighing or dimensions and their batch names 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 dosage forms that have been divided,

6.

the expiry date or the last date, and

7.

the signature of the person who manufactured the medicinal product.

The manufacturing protocol must be supplemented by a pharmacist with his confirmation that the manufactured medicinal products comply with the manufacturer's instructions (release). (3) A test instruction must be prepared for the examination of medicinal products for defectturation, which is to be signed by a pharmacist at the pharmacy. The test instruction must contain at least information on the sampling, the test method and the type of tests, including the permissible nominal or limit values. (4) The test shall be carried out in accordance with the test instruction referred to in paragraph 3 and shall be carried out by the Document the person who carried out the audit (audit trail). The audit trail must identify the underlying test statement and contain information in particular:

1.

on the date of the examination,

2.

the test results and their release by the pharmacist responsible for carrying out or supervising the test.

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§ § 9 and 10 (omitted)

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§ 11 Starting materials

(1) Only starting materials whose proper quality is established may be used for the manufacture of medicinal products. The requirements of § 6 (1) and (3) shall apply to the examination of the starting materials. (2) If starting materials are obtained, the quality of which is proven by a test certificate according to § 6 para. 3, at least the Identify identity. 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 at the pharmacy shall include records bearing the name of the pharmacist who is to be examined or supervised by the examination. (3) If medicinal products which are not ready for use are medicinal products for the manufacture of other medicinal products, , paragraphs 1 and 2 shall apply accordingly. Unofficial table of contents

Section 11a Activities on behalf of

(1) In so far as the pharmacy may have the manufacture of medicinal products carried out by other establishments in accordance with Section 21 (2) (1b) of the Medicinal Products Act or § 11 (3) or (4) of the Pharmacies Act, a written contract must be concluded between the pharmacy as a contracting authority and the other company as a contractor, which must be present in the two establishments. In the Treaty, the responsibilities of each side are clearly defined. The first sentence shall be applicable 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, insofar as they go beyond the identity check. (2) The Pharmacies shall not be required to produce a medicinal product until the medicinal product concerned has received a prescription from the medicinal product concerned and, after examination of the Regulation, there have been no objections. § 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. Unofficial table of contents

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

(1) Ready-to-use medicinal products which have not been 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. The first and second sentences apply to medical devices subject to apothecary requirements. (2) The test protocol to be produced must contain at least the following:

1.

the name or company of the marketing authorisation holder, 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 results of the examination;

5.

the name of the pharmacist supervising or supervising the inspection.

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§ 13 Containers

For the manufacture of medicinal products, only primary packaging materials may be used to ensure that the medicinal products are protected from physical, microbiological or chemical changes and which, therefore, are intended for use in the manufacture of medicinal products for the manufacture of medicinal products. are suitable for use. Unofficial table of contents

Section 14 Labelling

(1) Recipe medicinal products must have at least the following information on the containers and, where used, the outer envelopes:

1.

the name and address of the dispensing pharmacy and, where different, of the manufacturer,

2.

Content by weight, volume of space or number of pieces,

3.

the nature of the application,

4.

Instructions for use,

5.

Active substances by type, quantity and other ingredients, by type,

6.

the date of manufacture,

7.

Time of use with the reference "useable to" with the indication of day, month and year and, where necessary, indication of the shelf-life after opening the container or after the preparation of the ready-to-use preparation,

8.

where necessary, references to special precautions, storage or disposal of unused medicinal products or any other special precautions to avoid risks to the environment; and

9.

as far as the prescription drug has been established for use in human beings, the name of the patient.

The information must be in good legible writing and in a permanent manner, and must be written in German, with the exception of the number 5. 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 the case of medicinal products, subsets taken from ready-to-use medicinal products are, in addition to the label required by the Medicines Act, the name and the name of the medicinal product. (1b) For the labelling of medicinal products intended for human clinical trials, § 5 of the GCP Regulation shall be applied. (2) For the purpose of the marketing of medicinal products for use in the form of ready-to-use medicinal products, in one of the medicinal products used for the purpose of supplying the medicinal product, the following shall be applied. consumers are to be kept in stock and

1.

are medicinal products within the meaning of Section 2 (1) or (2) (1) of the Medicines Act and are not intended for clinical trial in humans; or

2.

are medicinal products within the meaning of Section 2 (2) (2), (3) or (4) of the Medicines Act;

§ 10 of the Medicines Act shall apply. If an admission pursuant to section 21 (2) (1) or a registration pursuant to § 38 (1) sentence 3 of the Medicines Act is not required for them, the indication of the approval or registration number is not required. The information provided for in Article 10 (1b) of the Medicinal Products Act may be waiver. (3) Medicines manufactured in pharmacy, which are not ready for use in manufacture and are intended for use in animals used for the production of foodstuffs, may not be used. shall be placed on the market only if the containers and, where used, the outer envelopes are provided with the information in accordance with § § 10 and 11 of the Medicines Act. (5) (omitted) Unofficial table of contents

§ 15 Prefratchkeeping

(1) The Head of Pharmacies shall keep in stock the medicinal products and medicinal products subject to pharmacies which are necessary to ensure the proper supply of medicinal products to the population, in a quantity which shall be at least equal to the average demand for one week. In addition, the pharmacy must be kept in stock:

1.

analgesics,

2.

Anaesthesia, including opioids for injection and immediate release of active substance and modified release of active substance,

3.

glucocorticosteroids for injection,

4.

antihistamines for injection,

5.

Glucocorticoids for inhalation for the treatment of flue gas intoxications,

6.

anti-foam agent for the 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.

Compounds, disposable syringes and cannulas, catheters, transfer devices for infusions, and products for blood glucose determination.

(2) The Head of Pharmacies shall 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 anti-toxin from horse,

2.

Diphtheria antitoxin from horse,

3.

Snake venom immune serum, polyvalent, Europe,

4.

Tollwut vaccine,

5.

Tollwut immunoglobulin,

6.

Varicella-Zoster-immunoglobulin,

7.

C1-esterase inhibitor,

8.

Hepatitis B immunoglobulin,

9.

Hepatitis B vaccine,

10.

Digitalis anti-toxin,

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 which is at least equal to the average requirement for two weeks. These medicinal products and medical devices are to be listed. Unofficial table of contents

§ 16 Storage

(1) Medicinal products, starting materials, medical devices and the usual pharmacotics and test equipment must be stored in a clear and clear manner 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 must be taken into account. (2) The storage containers for medicinal products and starting materials must be such 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. On the containers, the expiry date or, where appropriate, a verification date shall be indicated. (3) (omitted) (4) (omitted) Unofficial table of contents

§ 17 Acquisition and supply of medicinal products and medical devices

(1) Medicinal products may 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 Section 11a of the Pharmacies Act and paragraph 2a and only be handed out by pharmaceutical personnel. (2) The delivery by Boten of the pharmacy is permissible on a case-by-case basis without permission in accordance with § 11a of the pharmacy law; in so doing, the medicinal products are separate for each recipient. in each case, and each 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 shall also apply, where necessary. 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 in direct connection with the delivery. The provisions of § 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 Section 11a of the Pharmacies Act, the Head of Pharmacies shall have the right to to ensure that

1.

the medicinal product is packaged, transported and delivered in such a way as to maintain its quality and effectiveness,

2.

the medicinal product shall be delivered in accordance with the information provided by the contracting authority and, where appropriate, the delivery shall be In justified cases, the pharmacist may, contrary to the information provided by the contracting authority, in particular on account of the nature of the medicinal product, that the medicinal product will be delivered only against a written acknowledgement of receipt,

3.

the orderer shall be informed in an appropriate manner, if it is apparent that the dispatch of the medicinal product concerned cannot be effected within the time limit laid down in Section 11a (3) (a) of the Pharmacy Act,

4.

all medicinal products ordered, insofar as they may be placed on the market and available in the scope of the Medicines Act, shall be delivered,

5.

In the event of known risks in the case of medicinal products to the customer, possibilities for reporting such risks are available, the customer is informed of risks relating to him, and in order to prevent risks associated with medicinal products within the company defensive measures are carried out;

6.

the person being treated is indicated to be in contact with the treating physician or the treating physician, if any problems arise in the use of the medicinal product,

7.

the person being treated is informed that, as a condition for the supply of medicinal products, the person concerned must indicate, by placing an order, a telephone number under which it is to be sent by pharmaceutical staff of the pharmacy with permission to dispatch In accordance with § 11a of the pharmacy law, pharmacies will also be advised by means of telecommunication facilities without additional fees; 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 may not be carried out if there is a need for information or advice on the safe use of the medicinal product, which cannot be done in a different way than a 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 in the course of the in accordance with § 43 (1) sentence 1 of the German Medicines Act (Medicines Act). (3) Pharmacies shall not place on the market the medicinal products and medical devices subject to pharmacy requirements by means of self-service. (4) prescriptions of persons who are responsible for the exercise of the medicine, dentistry or veterinary medicine (5) The medicinal products issued 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 has been removed. The pharmacist shall have to record and sign any changes to the prescription or, in the case of prescribings in electronic form, to add the electronic prescription and the total document with a qualified electronic mail order. Signature according to the signature law. The provisions of the Narcotics prescriptions ordinance remain unaffected. (5a) By way of derogation from the first sentence of paragraph 5, the pharmacist may, during the period referred to in the second sentence of Article 23 (1), be entitled to another person, with whom he has prescribed the sentence. medicines by field of application and by the type and quantity of active ingredients of the same medicinal product as well as in the form of administration and pharmaceutical quality, if the prescribed medicinal product is not available and there is an urgent need to ensure the immediate use of the medicinal product (6) In the case of the release of the medicinal products, prescribtion and, in the case of a prescription pursuant to Article 3a (1), first sentence, of the prescription of the prescription of medicinal products, shall be indicated on the copy of the prescription, or in the case of prescribings in electronic form, add the electronic prescription

1.

the name or company of the proprietor of the pharmacy and its address,

2.

the name of the pharmacist, assistant pharmacist, pharmacist or pharmacist who has delivered the medicinal product, or the pharmacist who has supervised the charge; in the case of prescription in electronic form, the following shall be: to replace the name character with an electronic signature in accordance with the signature law, whereby the pharmacist has to ensure the traceability to the respective signatory and its documentation,

3.

the date of the levy,

4.

the price of the medicinal product,

5.

the uniform marking for the finished medicinal product, as defined in Section 300 (3) (1) of the Fifth Book of the Social Code, to the extent that it is intended for use in human beings.

By way of derogation from point 2, the head of pharmacy may, under the conditions laid down in section 3 (5), delegate the power to distinguish prescriptions to technical and 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, the following are: The following information shall be recorded for the purpose of tracing:

1.

the name of the medicinal product;

2.

the batch name and the quantity of the medicinal product,

3.

the date on which the purchase and the levy,

4.

the name and address of the prescribing physician and the name or company and address of the supplier; and

5.

Name, first name, date of birth and address of the patient or, in the case of the surrender intended for medical practice, the name and address of the prescribable physician.

(6b) The acquisition and supply of medicinal products containing the active substances lenalidomide, pomalidomide or thalidomide and the acquisition of these active substances shall be recorded as follows:

1.

the name and batch name of the medicinal product or the active substance;

2.

the quantity of the medicinal product or of the active substance,

3.

the date of purchase;

4.

the date of the levy,

5.

the name or the company and the address of the supplier;

6.

Name and address of the prescribing doctor or doctor and

7.

Name and address of the person for which the medicinal product is intended.

After dispatch of the copies of the forms pursuant to § 3a (7) of the Ordinance on prescription of medicinal products to the Federal Institute for Medicinal Products and Medical Devices, the date of dispatch shall be added to the data set out in sentence 1. (6c) Pharmacies shall be allowed to: from other pharmacies do not refer to medicinal products. Sentence 1 shall not be applied to medicinal products;

1.

referred to in Article 52a (7) of the Medicines Act in the context of the usual pharmacy operations of pharmacies,

2.

which are obtained from pharmacies for which the same permission has been granted in accordance with Article 1 (2) in conjunction with Section 2 (4) of the Pharmacy Act,

3.

which may be obtained from pharmacies in accordance with Article 11 (3) or (4) of the Pharmacy Act,

4.

which, after the closure of a pharmacy, are passed on to a subsequent authorisation holder in accordance with the pharmacies law; or

5.

which, in urgent cases, are obtained from a pharmacy; an urgent case exists if the medicinal product is to be administered without delay and if the medicinal product cannot be obtained or produced in good time.

Where medicinal products are obtained from pharmacies or passed on from them to other pharmacies, the batch name of the medicinal product must also be documented and communicated to the recipient. (7) As far as public pharmacies are concerned. The provisions of § 31 (1) to (3) as well as § 32 shall apply mutatily to hospitals with medicinal products. Sentence 1 shall apply to medical devices subject to apothecary requirements. (8) The pharmaceutical staff shall be able to confront a discernible drug abuse in a suitable manner. In case of reasonable suspicion of abuse, the levy shall be refused. Unofficial table of contents

Section 18 Imports of medicinal products

(1) Where ready-made medicinal products are brought within the scope of this Regulation in accordance with Article 73 (3) or (3a) of the Medicines Act, the following information shall be recorded:

1.

the name of the medicinal product imported;

2.

the name or business name and address of the marketing authorisation holder,

3.

the batch number, the amount of the medicinal product and the pharmaceutical form,

4.

the name or company name and 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 of the order and the levy,

8.

the name of the pharmacist who has issued the medicinal 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 the submission. 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 not be used by a pharmacy for the first time in shall be placed on the market if they are examined in accordance with Article 6 (3), sentences 1 to 3, and if 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 corresponding to the test protocol. Unofficial table of contents

Section 19 Acquisition and supply of veterinary medicinal products subject to medical prescription

(1) The acquisition and supply of medicinal products subject to medical prescription and intended for use in animals shall be subject to time-ordered evidence. The following shall be considered as sufficient proof:

1.

for the acquisition, the orderly compilation of delivery notes, invoices or goods accompanying documents, which result in:

a)

the name or company and address of the supplier;

b)

the name and quantity of the medicinal product, including its batch number,

c)

the date of purchase;

2.

for the submission of a double or a copy of the prescription with records of:

a)

the name and address of the consignee;

b)

the name and address of the prescribing veterinarian;

c)

the name and quantity of the medicinal product, including its batch number,

d)

the date of the levy.

To the extent that a prescription is not presented in written or electronic form in accordance with Section 4 (2) of the Ordinance on the prescription of medicinal products, the information provided for in the second sentence of sentence 2, also in conjunction with the fourth sentence, must be documented at the time of the submission. Where the medicinal product is not placed on the market in batches and has a date of manufacture in the cases of sentence 2 (1) (b) and (2) (c), it shall be indicated. (2) prescription-only medicinal products for use in the in the case of animals used for the production of foodstuffs, only one prescription submitted in two copies may be issued. 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 bears a date of manufacture. (3) The head of pharmacies shall have at least once a year the following: To calculate the inputs and outputs of the medicinal products subject to prescription to animals against the existing stock of these medicinal products and to detect deviations. Unofficial table of contents

Section 20 Information and advice

(1) In the framework of the quality management system, the pharmacy manager must ensure that patients and other customers, as well as persons entitled to the exercise of medicine, dentistry or veterinary medicine, are adequately informed about medicinal products and Medical devices subject to apothecary are informed and advised. 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) By providing information and advice to patients and other customers, the therapy of the practiser, dentistry or dentistry, may be used to treat the medicine. Veterinary medicinal products are not adversely affected. In so far as medicinal products are released without prescription, the pharmacist shall provide the patient and other customers with the information necessary for the proper application. (2) In particular, information and advice on medicinal products must be provided for: aspects of the safety of medicinal products are taken into account. 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 assist patients and other customers to make an informed decision, including in the case of: Reference to treatment options, availability, quality and safety of the services it provides; it also provides clear invoices and clear price information, as well as information on the permit or permit status of the pharmacy, the Insurance cover or other forms of personal or collective (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 pharmacies. Medical devices. He's a member of the Hospital's Medicines Commission. Unofficial table of contents

§ 21 Drug risks, treatment of non-marketable medicinal products

The Head of Pharmacies shall ensure that the following measures are taken in the case of medicinal products or medicinal products which are not marketable:

1.

All information on complaints concerning medicinal products, in particular on medicinal products such as quality and packaging defects, deficiencies in labelling and package leaflet, side effects, interactions with other medicinal products, contraindications and improper use shall be communicated to him or to the pharmacist responsible for his application without delay.

2.

He or the pharmacist appointed by him shall verify the information and arrange for the necessary security measures to be taken.

3.

Where it is justified in the case of medicinal products or starting materials which have referred to the pharmacy that the quality of the quality defects caused by the manufacturer is present, the competent authority shall be notified without delay.

4.

In the case of the recall of medicinal products which have been produced in the pharmacy, the competent authority shall be notified without delay, indicating the reason for the withdrawal.

5.

There are records of drug risks identified in the pharmacy, as well as the checks, measures and notifications that have been assessed.

6.

In the case of hospital pharmacies, without prejudice to points 1 to 5, he shall immediately inform the leading doctors and the medicinal products commission of the hospital of the risk of medicinal products which will become known to him.

7.

Medicinal products or starting materials which are not marketable or which are in the process of being returned shall be reworked, returned or destroyed, unless they are immediately re-worked, returned or destroyed, as such, to be identified as such and to be conserved. The measures shall be kept in record.

8.

Falsified medicinal products identified in the distribution network shall be kept separately from marketable medicinal products and secured in order to avoid confusion and access to unauthorised access to the market until the decision on further action is taken. prevent. They must clearly be labelled as non-sales medicines. The competent authority shall be immediately informed of the occurrence of counterfeit medicines. The measures taken are to be documented.

The Medical Devices Safety Planning Ordinance applies to medical devices. Unofficial table of contents

§ 22 General Documentation

(1) All records relating to the manufacture, testing, verification of the medicinal products in the hospital and facilities to be supplied within the meaning of Section 12a of the Pharmacies Act, storage, importation, placing on the market, recall, return of the medicinal products Medicinal products on the basis of a recall, the certificates according to § 6 (3) sentence 2 and § 11 (2) sentence 1 as well as the evidence in accordance with § 19 are complete and at least up to one year after expiry of the expiry date, but not less than five years, storage. 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 according to § 17 para. 6 sentence 1 No. 2 half-sentence 2 are after the last (2) records can also be recorded 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 time. In the case of a recording and storage exclusively on data carriers, a name symbol required by this Regulation shall be marked by an electronic signature according to the signature law and a personal signature by a qualified (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 § 17 (6a) shall be at least thirty years. to store or store and destroy or delete 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. Unofficial table of contents

§ 23 Service readiness

(1) Pharmacy shall be obliged to provide permanent service. The competent authority shall exempt a part of the pharmacies from the duty to service in whole or in part at the following times:

1.

from Monday to Sunday from 0:00 am to 8:00 am,

2.

Monday to Friday from 18:30 to 24:00,

3.

sonnabends from 14:00 to 24:00,

4.

on the 24th and 31 December from 14:00 to 24:00,

5.

on Sundays and on public holidays.

(2) The competent authority may, for the duration of the usual closing times, Wednesday afternoons, sunnights or operating holidays, and, if there is an justified reason, also outside of the obligation to provide service, the competent authority. During the period referred to in the second sentence of paragraph 1, it is sufficient to ensure that the supply of medicinal products by another pharmacy, which may also be located in another municipality, is ensured. Willingness to service when the head of the pharmacy or a person authorized to represent the person in question is in immediate vicinity to the pharmacy operating rooms and accessible at any time. 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 (5) In the case of pharmacies which are not ready for service, a legible notice to patients or other customers is to be affixed to the nearest pharmacies which are ready for use at the nearest point of view. (6) Pharmacies, hospitals with medicines and pharmacies Without prejudice to the provisions of paragraphs 1 to 4, provide medical products with the institution of the hospital to establish a service provision which shall ensure the proper supply of medicinal products to the hospital and to the provision of advice to the hospital. Pharmacist of the pharmacy is guaranteed. Unofficial table of contents

§ 24 Recipe of Recipes

(1) Bodies for the collection of prescriptions (reception centres) may only be maintained with the permission of 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 is permitted. (2) Recipe collection points must not be entertained in commercial establishments or in the case of health professionals. (3) prescriptions must be collected in a sealed container before access. protected by unauthorized 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 picked up at the times indicated by a messenger which must belong to the staff of the pharmacy. (4) The medicinal products are to be packed in the pharmacy separately for each recipient and each with its name. and address. 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

Section 25a Defense of menacing communicable diseases

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 11 (2) shall not apply to starting materials, which are used for the manufacture of medicinal products within the meaning of Article 21 (2) (c) of the Medicines Act, provided that:

1.

the quality of which is proven by a test certificate in accordance with § 6 (3),

2.

the container is closed in such a way that an intermediate opening of the container would be apparent, and

3.

Neither the container nor the closure are damaged.

In so far as the container is operated by an establishment in a Member State of the European Union or of the European Economic Area, which has an authorisation under Article 77 of Directive 2001 /83/EC, in accordance with national law, for the purpose of: If the raw material has been refilled or packaged in unaltered form, § 11 para. 2 shall not apply if the pharmacy has received a copy of the test certificate pursuant to § 6 (3) and a written confirmation of the holding that: in the case of the opening of the vessel, the conditions laid down in the first sentence of 1 to 3, and the The starting materials have been transferred or packed into suitable containers. 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 shall be made available to the competent authorities of the Federal Government or of the Länder.

Third Section
The operation of hospital pharmacies

Unofficial table of contents

Section 26 Applicable Rules

(1) The hospital pharmacy is the functional unit of a hospital, which ensures the proper care of one or more hospitals with medicinal products and medical devices subject to pharmacies, as well as information and (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 to the following: the operation of hospital pharmacies accordingly. Unofficial table of contents

§ 27 Head of the hospital pharmacy

(1) Pharmacy manager shall be the pharmacist appointed by the institution of the hospital and instructed by the management. (2) The head of the hospital pharmacist shall be responsible for ensuring that the pharmacy is operated in compliance with the applicable regulations. In particular, it shall ensure that:

1.

the ordered pharmaceuticals and medical devices subject to pharmacies are made available on demand and medicinal products that are urgently needed for acute medical care are made available immediately,

2.

the medicinal products stored in hospital and medical devices subject to pharmacotherapy are regularly reviewed and the verifications documented,

3.

a pharmacist of the pharmacy

a)

the staff of the hospital with a view to the safe, effective and cost-effective treatment of medicinal products and the use of medicinal products or medicinal products subject to pharmacovigilant medicinal products; and

b)

where necessary, the patient with a view to a safe use of medicinal products, in particular in connection with his dismissal from the hospital

advises.

The head of the hospital pharmacy is a member of the Medical Committee of the Hospital. (3) The head of the hospital pharmacist can only be represented by a pharmacist. This has the duties of the pharmacist during the period of representation. (4) The provisions of § 2 (3) and (5) shall apply accordingly. Unofficial table of contents

Section 28 Staff of the hospital pharmacy

(1) The staff necessary for the proper operation of the hospital pharmacy, and in particular the pharmaceutical staff, must be in sufficient numbers. The staffing requirements result from the type and extent of a medically appropriate 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. In accordance with the provisions of Section 3 (1), (5) and (6), the head of the hospital pharmacist shall be responsible for the use of the pharmacy staff. (3) accordingly. Unofficial table of contents

§ 29 Rooms and furnishings of the hospital pharmacy

(1) The rooms necessary for the proper operation of the hospital pharmacy must be present. In this connection, the type, nature, size and number of the rooms and the establishment of the hospital pharmacy must be aligned with the standards of § 28 (1) sentence 2. (2) The hospital pharmacy shall at least be made up of an officer, two laboratories, one There shall be a business area and a sub-room and must have sufficient storage space; in a laboratory, a deduction must 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 by analogy. (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 must be aligned with the size, type and performance structure of the hospital. The provisions of Section 4 (7) and (8) shall apply. Unofficial table of contents

§ 30 Vorratshaltung in der Krankenhausapotheke

The medicinal products and medical devices required to ensure proper care for the patients of the hospital must be kept in sufficient quantity to meet at least the average requirement for two weeks. These medicinal products and medical devices subject to pharmacotherapy are to be listed. Unofficial table of contents

§ 31 levy in the hospital pharmacy

(1) Medicinal products and medical devices subject to pharmacotherapy may only be delivered to stations or other subunits of the hospital on the basis of a prescription in individual cases or on the basis of a written request. This applies accordingly to prescriptions or requirements in electronic form. (2) In the case of delivery to stations and other sub-units of the hospital, the medicinal products and medical devices subject to pharmacies shall be unauthorised to access . 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 out-patient operation for use outside the hospital shall be subject to the conditions laid down in section 14 (1) (3) Medicinal products intended to be delivered to the consumer may not be delivered without an outer packaging only if the name of the medicinal product on the container is the name of the medicinal product, the product containing the product must be labelled with the following: the name of the batch and, where prescribed for the medicinal product, the The provisions of § 17 (1), (1a), (4), (5), (1) (1) to (3) and (2) and (3) and (3) and (6a) to (6c) shall apply accordingly. Unofficial table of contents

Section 32 Review of stocks of medicinal products and medical devices subject to pharmacovigilanship at the stations

(1) The obligation of the head of the hospital pharmacy or of a pharmacist responsible for the pharmacy to check the stocks of medicinal products in accordance with Article 14 (6) of the law on pharmacy extends to all the stations and medicinal products held in other subunits of the hospital; the review of the stocks of medicinal products must be carried out at least half a year. The first sentence applies to medical devices subject to pharmacies. (2) The checking pharmacist and the pharmacist who supports him are authorized to enter the rooms that serve the pharmaceutical supply. The hospital management and the remaining hospital staff must support the conduct of the review. (3) The head of the hospital pharmacy or the pharmacist responsible for the pharmacy of the pharmacy shall have a protocol in place for each inspection. To produce four copies. The Protocol shall contain at least:

1.

the date of the review;

2.

the name of the station or the other sub-unit of the hospital;

3.

the name of the pharmacist and of the other persons involved in the review;

4.

the nature and extent of the review, in particular with regard to:

a)

the general storage and storage conditions,

b)

the storage and storage of medicinal products and medical devices in accordance with the recognised pharmaceutical regulations;

c)

of the nature, including the labelling of medicinal products and medical devices,

d)

of the decay data,

5.

the deficiencies noted,

6.

the measures to be taken to remedy the shortcomings,

7.

the deadline set for the elimination of the deficiencies,

8.

Information on the removal of previously identified deficiencies,

9.

the signature with the date of the pharmacist responsible for the inspection.

A copy of the protocol shall be assigned to the hospital management at the latest four weeks, in the event of serious defects immediately after the examination has been carried out, and one more shall be handed out to the physician and to the care service, who shall: for 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. Unofficial table of contents

§ 33 Service of the hospital pharmacy

The holder of the permit shall ensure that a service is available to ensure that the hospital is properly supplied to the hospital. This also implies that advice is provided by a pharmacist of the pharmacy.

Fourth Section
Special provisions

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Section 34 Patient-specific points or sublimation of medicinal products

(1) In the quality management system according to § 2a, the following provisions shall in particular be made:

1.

for the selection of medicinal products which are in principle eligible for a job or a re-remainder, or which are not suitable for vacancies or for the re-remainder,

2.

the decision on which medicinal products may not be stored in the same container for simultaneous use or which may be left in the same single blister pack,

3.

for the decision, in which exceptional cases a written medical request concerning a division of tablets to be carried out in front of the body or the blister, if otherwise the supply cannot be secured and in the case of a proven condition Validation of the stability of their quality over the shelf life of the blister or the reusable container may be followed, if necessary, although the subsequent modification of the finished medicinal product is generally prevented should,

4.

on the temporary storage and labelling of the medicinal products which have been unleaned,

5.

on the technical and organisational measures to maintain the quality of the deblistered medicinal products and, in particular, to avoid cross-contamination and confusion, including the verification of their effectiveness,

6.

for the calibration, qualification, maintenance and cleaning of the automatic blister machines, where used, or other critical equipment or equipment,

7.

to the primary packaging materials and their quality checks,

8.

to the manufacturing instructions and the production protocols referred to in § 7,

9.

to the hygiene plan and

10.

to the hygienic behaviour of the staff at the workplace and the nature of the protective clothing for the manufacture of medicinal products, including the manner and frequency of the changing operations.

(2) The staff must be sufficiently qualified for the activities and must be trained on a regular basis; the training measures must be documented. The staff required for the first sentence of Article 3 (2) shall be determined by the scope of the production. (3) By way of derogation from § 4 (2b), the individual bodies or submasters shall be provided in a separate room, which shall be reserved exclusively for this purpose. Purpose may be used. 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 the body or the manual blister of medicinal products is to be carried out in exceptional cases for a single patient. (4) From the labelling of the newly packaged medicinal product the following information must be provided:

1.

the name of the patient,

2.

the medicinal products contained therein and their batch designations;

3.

the expiry date of the newly assembled medicinal product and its batch number;

4.

the statement of revenue,

5.

any storage or storage instructions, and

6.

the dispensing pharmacy and, where different, the manufacturer.

The package leaflet of the pre-packaged medicinal products shall be attached to the newly packaged medicinal product in accordance with Article 11 (7) of the Medicines Act. Unofficial table of contents

Section 35 Manufacture of medicinal products for parenteral use

(1) In the quality management system according to § 2a, provisions shall be made, in particular,

1.

to the medicinal products to be used and to the primary packaging materials and their quality checks,

2.

on the technical and organisational measures to avoid contamination, cross-contamination and confusion, including verification of their effectiveness,

3.

the calibration, qualification, maintenance and cleaning of equipment and the manufacturing area,

4.

for the validation of the processes, methods and systems influencing the quality of the product and for revalidation; in aseptic production processes at the end of each working day, involving the manufacturing staff concerned,

5.

to the critical equipment or equipment,

6.

to the manufacturing instructions and production protocols in accordance with § 7 or § 8,

7.

on the possible transport of the manufactured medicinal products,

8.

to the hygiene measures and

9.

to the hygienic behaviour of the staff at the workplace and the nature of the protective clothing for the manufacture of medicinal products, including the manner and frequency of the changing operations.

(2) The staff must be sufficiently qualified for the activities and must be trained on a regular basis; the training measures must be documented. The staff required under the first sentence of Article 3 (2) 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, in so far as it may be is not 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 carried out by means of filters adequate effectiveness. 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 must be applied accordingly. (4) Insofar as the medicinal products are not subjected to a sterilization procedure in the final container and are not produced in the closed system, during preparation and filling

1.

In the local area for the operations, an air quality level for the number of bacteria and the number of particles corresponding to class A of the definition of the EC-GMP guideline, Annex 1, which is made known by the Federal Ministry in the Federal Gazette in the current version shall be respected and

2.

a suitable environment is required in relation to particle and germ count

a)

at least equal to category B of the Annex to the guide

b)

or, by way of derogation from category B, at least in accordance with class C of the Annex to the Guide, where the quality of the medicinal product is demonstrated by the method used, and if the procedure is validated by appropriate validation;

c)

or in the case of the use of an insulator of class D of the Annex to the guide.

For the preparation of medicinal products which are not produced in the closed system but are subjected to a sterilisation process in the final container, a derogation from the first subparagraph of point 2 (a) shall require an environment in respect of: The number of particles and germs of at least Class D of the Annex to the guide shall be equal to a level of air purity of Class C for the filling of these medicinal products. (5) Clean room conditions shall be determined by appropriate air control, Surfaces and personnel on the basis of particle and germ payment provisions during of the manufacturing process in open systems. The pharmacists responsible for the release procedure must set appropriate limits for warning and action for this purpose. (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. . Unofficial table of contents

§ § 35a and Others 35b (omitted)

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Fifth Section
Irregularities, Transitions and Final Provisions

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§ 36 Administrative Offences

Contrary to the provisions of Section 25 (2) of the law on pharmacy, who intentionally or negligently is acting in a negligent manner

1.

in accordance with Article 3 (5) sentence 1 in conjunction with the second sentence, carries out pharmaceutical activities,

1a.

, contrary to Article 17 (1a), first sentence, of a medicinal product,

1b.

Contrary to § 17 para. 2b, a medicinal product referred to in this section shall be placed on the market by means of a marketing agent,

2.

as a pharmacist

a)

a provision of the first, second or third sentences of § 2 (5) or (3) concerning the representation of the head of pharmacist,

b)

does not operate a quality management system in accordance with the first sentence of Article 2a (1)

c)

, contrary to § 3 (5) sentence 1, in conjunction with § 2 para. 2 sentence 2 and 3 or § 3 para. 5 sentence 2, the pharmaceutical activities can be carried out,

d)

, contrary to § 3 (5) sentence 3 in conjunction with § 2 para. 2 sentence 2 and 3, pharmaceutical activities are not supervised or cannot be supervised by a pharmacist,

e)

, contrary to Article 15 (1), second sentence, a medicinal product referred to therein is not held in stock;

f)

does not ensure, contrary to Section 15 (2), that a medicinal product referred to therein is held in stock or that it can be procured in the short term,

g)

Contrary to § 17 (1a) sentence 1, medicinal products outside of the pharmacy premises or, contrary to § 17 para. 3, medicinal products subject to pharmacies shall be placed on the market by means of self-service,

h)

Article 17, paragraph 7, in conjunction with section 31 (1) sentence 1 or paragraph 3, also in connection with § 2 para. 2 sentence 2 and 3, issuing or allowing the release of medicinal products,

i)

Contrary to § 17 (7) in conjunction with section 32 (1) and with § 2 (2) sentence 2 and 3 on the stations or in other subunits of the hospital, medicinal products held in stock are not, not completely or not checked in time, or by means of a Pharmacist, in connection with § 32 para. 3 and with § 2 para. 2 sentence 2, does not allow the prescribed protocol to be checked, not correctly or incompletely, not to be directed to the hospital management, not to the competent authority Doctor or do not store or do not carry out these measures by a pharmacist ,

j)

Contrary to § 21, it is not ensured that the measures referred to therein are taken in the case of medicinal products or non-marketable medicinal products,

k)

Contrary to Article 23 (1), the pharmacy is not ready for service,

l)

Contrary to § 23 (5) in conjunction with the second sentence of § 2 (2) and 3 (3), a legible indication of the nearest serviceable pharmacies shall not be applied or brought to the attention of the nearest pharmacies in the near future,

m)

, contrary to the first sentence of Article 24 (1), a reception office without the necessary permission has been given,

3.

as a pharmacist or a member of the pharmaceutical staff

a)

(dropped)

b)

Contrary to § 7 (1) sentence 1, medicinal products are not manufactured in accordance with the prescription or are used in the manufacture of other components other than those mentioned in the prescribing without the consent of the presenter, contrary to § 7 para. 1 sentence 2.

c)

(dropped)

d)

Article 14, para. 1, medicinal products without the prescribed labelling,

e)

, contrary to the first sentence of Article 16 (1) or the second sentence, a medicinal product, a starting material or a medical device is not stored correctly or not in the prescribed manner;

f)

(dropped)

g)

(dropped)

h)

Contrary to the first sentence of Article 18 (1), the prescribed data shall not be drawn up when medicinal products are placed on the market,

i)

Contrary to the first sentence of Article 19 (1), it does not carry out the evidence required there or, contrary to the first sentence of Article 19 (2), provides the medicinal products referred to therein without there being a two-fold prescription,

j)

keeping records, certificates or proof of proof not corresponding to the first sentence of Article 22 (1) 1 or, contrary to § 22 (1) sentence 2 or 3, records, certificates or evidence of unrecognizable power or changes,

k)

shall not, contrary to the first sentence of Article 22 (4), retain a record, or not, for at least thirty years, or store it or not, or not,

4.

as head of a hospital pharmacy

a)

Contrary to Article 26 (2) in conjunction with Section 21, the measures referred to therein shall not be taken into account in the case of medicinal products or non-marketable medicinal products,

b)

Contrary to § 28 (3) in conjunction with § 3 (5) sentence 1 and with section 27 (2) sentence 1, the pharmaceutical activities can be carried out,

c)

Contrary to § 28 (3) in conjunction with Section 3 (5) sentence 3 and with Section 27 (2) sentence 1, pharmaceutical activities are not supervised or cannot be supervised by a pharmacist,

d)

in accordance with § 31 (1) sentence 1, para. 3 or 4 in conjunction with section 17 (5) sentence 1, in each case in conjunction with section 27 (2) sentence 1, issuing or issuing medicinal products, or

e)

, contrary to § 32 (1) in conjunction with Section 27 (2) sentence 1 on the stations or in other subunits of the hospital, no medicinal product is kept in stock, is not fully or not checked in time or is checked by a pharmacist or, contrary to § 32 (3) in conjunction with § 27 (2) sentence 1, does not allow the prescribed protocol, not properly or incompletely, not to be supplied to the hospital management, not to be handed over to the competent doctor or not to be kept , or these measures cannot be carried out by a pharmacist.

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Section 37 Transitional provisions

(1) In pharmacies, for which a permit pursuant to § 1 (2), also in conjunction with § 2 (4), of the Pharmacy Act has been granted before 11 June 2012, § § 2a, 4 (1) sentence 2 (1) (a), § 34 (3) sentence 1 and 4, and § § § 2 (1) (1) (1) (a)) 35 (3), second sentence, not to be applied until 1 June 2014; however, until that date, the rooms must continue to comply with the provisions in force until 11 June 2012. (2) On pharmacies for which prior to 11 June 2012 a permit pursuant to § 1 paragraph 2, also in connection with § 2 paragraph 4, of the pharmacy law has been granted, is § 35 paragraph 5 as of 1 June 2013 , until that date, the clean room requirements must be verifiably at least equivalent to the requirements of Class A for the local zone and Class C for the surrounding area. Unofficial table of contents

Appendix 1 (omitted)

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Appendix 2 (omitted)

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Appendix 3 (omitted)

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Appendix 4 (dropped)

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