How to define the right ambient temperature range for storage and distribution of pharmaceutical raw materials.

To ensure the quality of raw materials for pharmaceutical products, the right storage and distribution temperature conditions should be applied. Labeled temperature conditions of 539 raw materials at non-cold chain conditions (thus excluding 2-8 °C or < 0 °C conditions) were reviewed that revealed a set of 26 different temperature requirements. From a manufacturer perspective, it is hard or undoable to manage that number of temperature conditions, especially because regulatory guidance towards raw material temperature conditions is lacking.

Integration of temperature-controlled requirements into pharmacy practice.

Objectives: To describe (a) Food and Drug Administration (FDA) regulations and guidelines issued by several professional organizations to ensure appropriate storage, handling, and distribution of temperature-controlled prescription drugs from manufacturer to wholesaler to pharmacy to patients; (b) pharmacy business practices that ensure the dispensing of high-quality temperature-controlled drug products; and (c) education that facilitates patients' important role in maintaining product quality.

Data Sources: PubMed from 1950 to 2007 using the search terms drug stability in transit, drug stability storage tablet, drug stability testing, drug stability transportation, drug stability relative humidity, and drug storage high temperature. Nonprimary sources included the FDA website (www.