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Ars Pharmaceutica (Internet)
versão On-line ISSN 2340-9894
Resumo
NOGUERA-PENA, Alfonso e CASTILLO-RODRIGUEZ, Carlos del. Non-industrially elaborated or prepared drugs: a new classification proposal. Ars Pharm [online]. 2021, vol.62, n.4, pp.379-388. Epub 15-Nov-2021. ISSN 2340-9894. https://dx.doi.org/10.30827/ars.v62i4.21094.
Introduction:
Neither the legislator nor the different previous studies have established an exhaustive classification of non-industrially elaborated or prepared drugs in the Spanish regulatory territory.
Method:
Bibliographic review on the regulations (national and community) and doctrinal studies related to the legal framework of medicines for human use, and their analysis.
Results:
There is no adequate classification of non-industrially elaborated or prepared drugs in the literature.
Conclusions:
A doctrinal classification of non-industrially elaborated or prepared drugs has been proposed based on four main categories.
Palavras-chave : Legislation; Radiopharmaceuticals; Advanced Therapy: Gene Therapy; Pharmacy compounding.