Pharmacy operating regulations

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Basic data
Title: Ordinance on the operation of pharmacies
Short title: Pharmacy operating regulations
Abbreviation: ApBetrO
Type: Federal Ordinance
Scope: Federal Republic of Germany
Issued on the basis of: § 21 ApoG ; §§ 12, 73 Paragraph 3 AMG ; §§ 11, 37 MPG
Legal matter: Special administrative law , health law
References : 2121-2-2
Original version from: August 7, 1968
( Federal Law Gazette I p. 939 )
Entry into force on: 1st January 1969
New announcement from: September 26, 1995
( BGBl. I p. 1195 )
Last revision from: February 9, 1987
( BGBl. I p. 547 )
Entry into force of the
new version on: 		July 1, 1987
Last change by: Art. 2 G of January 13, 2020
( Federal Law Gazette I p. 66, 80 )
Effective date of the
last change: 		January 1, 2023
(Art. 4 G of January 13, 2020)
GESTA : M026
Please note the note on the applicable legal version.

The Pharmacy Operation Regulations (ApBetrO) regulate the details of the operation of pharmacies (public pharmacies, hospital pharmacies , emergency and branch pharmacies and hospital supply pharmacies) in Germany and was issued on the basis of the statutory authorization in Section 21 of the Pharmacies Act.

The pharmacy operating regulations have been changed several times in recent years. In June 2012, extensive changes came into force again.

Operation of public pharmacies

Public pharmacies must be managed personally by a pharmacy manager (usually the owner of the pharmacy). The pharmacy manager is responsible for the proper operation of the pharmacy: he has to ensure that the pharmacy is operated in compliance with all applicable regulations. In addition to medicines only-pharmaceutical products such as must medical devices , chemicals , agents for raising animals, pesticides and plant protection products are available in the range.

The pharmacy staff is divided into two groups: Pharmaceutical activities may include in particular the delivery of drugs and information and advice on medicines to be done by pharmaceutical staff (especially pharmacists , pharmaceutical engineers , pharmaceutical technicians ) are exercised. The non-pharmaceutical staff (especially pharmaceutical-commercial employees ) can provide limited support here and their main task is inventory management.

Minimum standards with respect to the premises of a pharmacy are accurately defined so must a public pharmacy at least one Offizin (the sales room), a laboratory , storage and a night service room (for the stay during the pharmacy emergency service ) with a total area of 110 m² have. In principle, all of the pharmacy's premises should be directly adjacent to one another; However, this does not include the night duty room , in the case of mail-order pharmacies, the rooms for processing pharmaceuticals and rooms for the exclusive production of cytostatics . It also stipulates which devices (for in-house production of drugs in the pharmacy), which scientific aids (e.g. the pharmacopoeia ) and pharmacy-relevant legislation must be available.

The manufacture of pharmaceuticals in the form of prescriptions and defects and the testing of finished pharmaceuticals in particular are regulated, as are the requirements for the mail-order business with pharmaceuticals. Certain drugs that are required immediately in urgent cases such as poisoning must be kept in every pharmacy or be available at short notice ( emergency depot ). The duty of the pharmacist to record drug risks, as well as his duties in providing drug information to patients and other health professionals, are also explicitly laid down .

Operation of hospital pharmacies

Regarding the regulations for the operation of hospital pharmacies, reference is mainly made to the regulations that also apply to public pharmacies. There are differences, for example, with the pharmacy manager. This is an employee of the hospital (not an independent entrepreneur ) and may only be represented by a pharmacist in the event of absence (in a public pharmacy this can also be done by a pharmacist's assistant or a pharmaceutical engineer). Other requirements apply to the premises (for example, two laboratories are stipulated, the floor space of the operating rooms must total at least 200 m²) and the pharmaceuticals to be kept available (must cover the requirement for two weeks instead of one).

Prescribed equipment

The 4 annexes valid until the new version of the ApBetrO 2012 are no longer applicable, their content is described in the respective paragraphs ( § 15 - Medicines, § 4 - Devices, § 5 - Scientific and other aids). In terms of the size and condition of the premises, all pharmacies have specifications for the design of the prescription (separation) and the dispensary (confidentiality zone). New regulations have been added for pharmacies that provide medicines (home supply) or blister packs, which are also reflected in the requirements for the rooms required for this.

Medicines to be kept available at all times

Regardless of the drugs prescribed in principle but not in detail (average weekly requirement), the following drugs must always be available in every pharmacy for emergencies ( Section 15 (1) sentence 2 ApBetrO):

In addition, the following drugs must be kept in stock by every pharmacy for emergencies or be able to be procured at short notice ( Section 15 (2) sentence 2 ApBetrO):

While the procurement of immune sera from certain hospitals has been a tried and tested concept for decades, the procurement of narcotics from hospitals for public pharmacies is not possible for legal reasons. Such a transfer is only permitted between the main pharmacy and branch pharmacy. For this reason, the chambers of pharmacists take the view that transdermal and transmucosal opioids must be available in every public pharmacy in addition to the narcotics already mentioned above.

Objectives of the 2012 revision

The main goals of the fourth regulation amending the ApBetrO of June 5, 2012 were improved drug safety, especially in drug production as well as in information and advice and improved supply by the pharmacy.

For example, the following were added or changed:

  • § 2a : an additional quality management system (QMS) for pharmaceutical activities. The QMS already introduced by most pharmacies was used to fulfill contracts with the health insurance companies in order to obtain authorization to supply aids such as needles for diabetics , compression stockings, etc.
  • § 4 : The minimum room size of 110 square meters remained unchanged. However, additional space is required when the special manufacturing processes (parenteral production, placement of drugs, blister packaging ) are carried outin the pharmacy, whichmust be subject to special space requirements for reasons of drug safety.
  • § 6 to § 8 : Requirements for the testing, production and documentation of prescription drugs
  • Section 11a : Pharmacies may outsource selected pharmaceutical activities to external companies.
  • Test devices, test equipment and custom-made solutions are no longer listed individually (previously in Appendix 1 of the pharmacy operating regulations).
  • Section 20 : Analysis and advice in the context of medication management in accordance with Section 3 (4) ApBetrO are particularly demanding pharmacy activities and cannot be transferred.

Web links

Individual evidence

  1. ↑ Fourth ordinance amending the ApBetrO of June 5, 2012, Federal Law Gazette I p. 1254
  2. ↑ New preparation list for emergency depots (AKNR)
  3. ↑ Fourth ordinance amending the DIP pharmacy operating regulations , accessed on July 20, 2020.
  4. ^ Ordinance of the Federal Ministry of Health, Fourth Ordinance to Change the Pharmacy Operating Regulations BR-Drs. 61/12 of February 3, 2012, p. 32.
  5. ↑ Pharmacy operating regulations Overview of the major changes. Die Apotheke 2012, p. 195 ff.