Pursuant to Section 1 (2) of the Pharmacy Operations Ordinance 2005, public pharmacies are responsible for the proper supply of medicines to the population. This duty of care is fulfilled, among other things, by
- the dispensing of medicinal products in small quantities
- the preparation of medicinal products in accordance with medical, dental or veterinary prescriptions,
- the independent preparation of medicinal products for consumers or users,
- the manufacture and marketing of proprietary medicinal products in accordance with legal requirements,
- the occasional supply of medicinal products to other pharmacies,
- the import of medicinal products in accordance with the provisions of the Act on the Import of Medicinal Products.
Institutional pharmacies may also, in accordance with Section 36(1) of the Pharmacy Act, supply medicinal products only to
- institutional pharmacies and
- persons under the care of the institution or residing in the institution.
The general rules on the distribution of medicinal products are standardized in Section VI of the Medicinal Products Act. Sections 57 et seq. of the Medicinal Products Act regulate who may dispense medicinal products to whom and under what conditions. The distribution of medicinal products by a pharmacy (public pharmacy or institutional pharmacy) to wholesalers is not provided for.
In summary, it can be stated that the supply of medicinal products to wholesalers is not provided for by law, neither for public pharmacies nor for institutional pharmacies, and is therefore not permitted. This does not apply to the justified withdrawal of medicinal products pursuant to Section 33 of the Medicinal Products Ordinance 2009 by the wholesaler supplying the pharmacy.
In order to achieve the objectives of pharmaceutical quality assurance, every company must have a sufficient number of competent and appropriately qualified personnel, whose tasks and responsibilities must be reflected within the company in an organizational chart and in job descriptions.
The pharmaceutical company regulations do not specify a specific number of competent and appropriately qualified persons, although this number must be determined by interpretation based on the size of the company and the associated tasks.
On the part of the Federal Office for Safety in Health Care (BASG)/AGES Medical Market Inspectorate, there is no question that each establishment, in accordance with its licensed activity, must have more than the minimum number of qualified persons specified in §§ 6 ff of the Medicinal Product Establishment Ordinance (AMBO), BGBl. II no. 324/2008, as amended, i.e., they must be employed locally in Austria and the responsibilities and tasks assigned to the personnel in question cannot, in principle, be outsourced or shared by a third company, even if it belongs to the same group of companies or "the like".
In summary, it can be said that the personnel who are competent and appropriately qualified to achieve the objectives of pharmaceutical quality assurance must be employees of the pharmaceutical company in Austria. Delegation of tasks and responsibilities to another company in the EEA is not permitted.
As a rule, pharmacies are not allowed to supply medicinal products to wholesalers or wholesalers are not allowed to purchase medicinal products from pharmacies (cf. Section 3 AMBO and Section 1 ABO). An exception to this generally inadmissible supply by pharmacies to wholesalers are returns that are unavoidable in business life.
A pharmacy's return to wholesalers is permissible without exception if it can be documented comprehensibly and without gaps that the returned goods were also delivered to this pharmacy by the wholesaler to whom the return was made or that a recall was initiated by the wholesaler. In all other cases, from the point of view of the BASG, this is a non-permitted delivery to the wholesaler.
If the goods were accepted by the wholesaler, this would constitute a violation of Section 3 AMBO 2009.
If the medicinal product is intended for destruction at the time of return (medicinal product is or will soon be no longer marketable) and it is ensured that it will not reach the consumer/patient, there is no placing on the market according to Section 2 (11) AMG. In this case, the product can be taken back for disposal by the wholesale trade.
For returns of narcotic drugs and psychotropic substances, the following should also be noted:
- Returns of narcotic drugs and psychotropic substances must be kept to a minimum. This is due to the fact that each company has a license limited to substances and quantities and that complete traceability of the management is required.
- Each return must also be recorded as a reference in the reservations and consequently in the statement. Returns of complete retail packages are to be reported in the statement as a reference in the column "Returns from retail trade (for examination of disposal/reintegration)" in the tab "Preparations". After checking the saleability, these can be assigned to the sales stock or sent for destruction. After physical disposal, the quantity must be reported in the "Disposal" column as part of the verification report. Reference is made to Section 8 (1) (2) of the Narcotic Drugs Ordinance and Section 8 (1) of the Psychotropic Drugs Ordinance.
- The return of narcotic drugs by pharmacies to wholesalers for the purpose of disposal must also be recorded in the records and consequently in the verification report. Due to the fact that pharmacies and institutional pharmacies can dispose of addictive substances free of charge via the laboratory of the Austrian Chamber of Pharmacists, however, there should be no need to return them to wholesalers.
Wholesalers are not allowed to sell medicinal products directly to physicians in charge of a home pharmacy or to veterinarians without a home pharmacy (Section 57 AMG). This means that returns to wholesalers by physicians in charge of a home pharmacy or physicians in private practice as well as veterinarians without a home pharmacy are not permitted. The wholesale trade can only act as a vicarious agent of a commissioning pharmacy, which is authorized to dispense to house pharmacy-managing or established physicians and veterinarians. The following points must be observed:
- The dispensing of medicinal products takes place without exception in the name and on the responsibility of the pharmacy (§ 59 AMG).
- It must be ensured by means of a contract that the orders/deliveries/returns received by the vicarious agent (wholesaler) can be checked, monitored and objected to by the commissioning pharmacy at any time in order to ensure that the commissioning pharmacy is involved in accordance with the law.
- In the case of returns, a return form must exist, which must contain at least the following information:
- Name and address of the returning pharmacy
- Return date
- Pharmaceutical speciality
- Reason for return
- Date of receipt of the drug
- Name and address of the pharmacy responsible for the order
- in case of refrigerated goods and narcotic drugs - temperature protocols as attachment
For the assessment of marketability, § 33 par. 3, 4 and 5 AMBO 2009 in conjunction with Commission Guideline 2013/C 343/01 point 6.3 and Directive 2011/62/EU must be observed.
The processing of returns requires the following documentation, which must be available at the wholesaler (vicarious agent) when the goods are reintegrated:
- Date of receipt of the return
- Check whether and when the goods or batch were actually delivered
- indication of a reason for the return (wrong delivery/misorder/other discrepancy/quality defect/recall)
- Check and evaluation of the enclosed temperature records over the period of delivery until return
- Date and decision of the assessment of marketability
Does an identified deficiency in the quality assurance system of one contractual partner also lead to a deficiency in the quality assurance system of the other contractual partner? Compliance with the legal requirements, in particular Good Manufacturing Practice and Good Distribution Practice, must be ensured and contractually regulated by both contracting parties. The customer must ensure the suitability of the contractor before taking over the activity in the contract and verify this in audits. A prerequisite for this is also that the contractor has all the information required to perform the contractually agreed service in compliance with the law and guidelines. The quality assurance systems of the contracting parties are thus interconnected in a wide variety of areas and cannot be considered exclusively separately. A defect that is identified in the course of an inspection in the quality assurance system of one contractual partner can therefore also lead to a defect in the quality assurance system of the other contractual partner. The obligation to remedy such a defect is borne by both contracting parties, but primarily by the party in whose inspection the defect was initially detected. Alternatively, a separate § 63 AMG permit must be obtained at the external site or § 12 AMBO 2009 "Transfer of premises" must be applied. Legal basis: §§ 63 ff AMG, §§ 12 and 29 AMBO, GMP Guideline Part 1 Chapter 7 "Outsourced Activities".