Lucyna Bułaś, Michał Jachowicz, Agnieszka Skowron

Legal regulations for preparation of compounding and commercial (pharmaceutic) medications in the community pharmacy
2018-03-15

Pharmaceutical compounding and preparation of pharmaceutics are strictly regulated by appropriate standards of their manufacturing, depending not only on the knowledge and experience of the pharmacy staff, by also on the Pharmaceutical Law and relevant administrative acts.

The article provides a comprehensive analysis of some legal issues, related to the pharmaceutical compounding, aiming at its possible application for establishing procedures, and instructions, as well as for organizing a daily work, involving preparation of compounding and commercial (pharmaceutic) medications.

Complying with the legal rules, which determine requirements with regard to the place of medication manufacturing, necessary equipment and facilities, qualified pharmacy personnel, and documentation of the performance (mandatory for an appropriate manufacturing) directly translates into the medication quality.

This article is also showing that the basic definitions, included in the regulatory procedures, determine not only the place of service, but also the source of indications for the formulary ingredients, and methods of the medication manufacturing.

Keywords: compounding medication, commercial (pharmaceutic) medication, community pharmacy, legal regulations

© Farm Pol, 2018, 74 (3): 170–177