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.

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