Regulatory issues regarding veterinary medicines production in compounding pharmacies and pharmaceutical industries

Authors

  • Larissa Ferreira de Jesus Departamento de Produção e Controle de Medicamentos, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul. Endereço: Av. Ipiranga, 2752, Bairro Petrópolis, Porto Alegre - RS, CEP: 90610-000.
  • Diego Fontana de Andrade Departamento de Produção de Matéria-Prima, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul. Endereço: Av. Ipiranga, 2752, Bairro Petrópolis, Porto Alegre - RS, CEP: 90610-000. http://orcid.org/0000-0003-4639-3519
  • Karina Paese Departamento de Produção e Controle de Medicamentos, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul. Endereço: Av. Ipiranga, 2752, Bairro Petrópolis, Porto Alegre - RS, CEP: 90610-000.

DOI:

https://doi.org/10.14450/2318-9312.v35.e1.a2023.pp14-28

Keywords:

veterinary medicinal product, veterinary pharmacy, pharmaceutical regulation

Abstract

The animal health products segment has been growing steadily, reflected in an increase in veterinary medicines and veterinary-compounded preparations. In this scenario, a critical analysis of Brazilian law in force, which establishes norms for the exercise of veterinary pharmacy, is necessary. An integrative review was carried out, through the search for scientific articles in the PubMed, Science Direct, and Scielo databases, in addition to a consultation with the current Brazilian legal system relevant to the subject. As a result, 193 documents were retrieved, including scientific articles and legal norms. Furthermore, after the screening and eligibility assessment processes, according to previously established inclusion and exclusion criteria, 36 references were included in the review. Veterinary compounding stands out for the possibility of a customized product for each animal. The pharmacist’s role is to evaluate the prescription, manipulate, supervise, and guide the use of the prescribed formulation. In the veterinary industry, although the law allows veterinarians to act as technical managers for both pharmaceutica  products and the establishments that produce them, the pharmacist is a professional who is more able to assume this role due to the particularities of technical and scientific training. When reviewing the main legislation related to veterinary pharmacy, the need to review the law in force in Brazil is noted.

Author Biography

Diego Fontana de Andrade, Departamento de Produção de Matéria-Prima, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul. Endereço: Av. Ipiranga, 2752, Bairro Petrópolis, Porto Alegre - RS, CEP: 90610-000.


Professor Adjunto A no Departamento de Produção de Matéria-Prima da Faculdade de Farmácia da Universidade Federal do Rio Grande do Sul. Pesquisador colaborador dos grupos de pesquisa Nano3D, da Faculdade de Farmácia, da Universidade Federal do Rio Grande do Sul (UFRGS) e do Grupo GEPROS da Universidade Federal de Santa Catarina (UFSC). Farmacêutico pela Universidade Federal de Santa Maria (2011), Mestre (2013) e Doutor (2017) em Ciências Farmacêuticas pela Universidade Federal do Rio Grande do Sul. Tem experiência no desenvolvimento, caracterização e controle de qualidade de insumos farmacêuticos e medicamentos para uso humano e veterinário. Possui vivência em sistemas de gestão da qualidade baseados na norma ABNT NBR ISO/IEC 17025. É membro da Associação Brasileira de Ciências Farmacêuticas (ABCF).

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Published

2023-04-24

How to Cite

de Jesus, L. F., de Andrade, D. F., & Paese, K. (2023). Regulatory issues regarding veterinary medicines production in compounding pharmacies and pharmaceutical industries. Infarma - Pharmaceutical Sciences, 35(1), 14–28. https://doi.org/10.14450/2318-9312.v35.e1.a2023.pp14-28

Issue

Vol. 35 No. 1 (2023)

Section

Review Article

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