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. Therefore, the question raised whether it would be possible to define subsets of temperature conditions in order to simplify the storage and distribution management of raw materials. The data set was further analyzed and it resulted in a new storage and distribution model of three temperature conditions for raw materials: 15-25 °C, 2-30 °C and unrestricted (no minimum and maximum temperature limit). The model can be applied to all non-cold chain raw materials by suppliers and manufacturers in order to harmonize temperature conditions and to manage temperature excursions easier during operations.

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.fda.gov), presentations from meetings or workshops, and websites of professional organizations. Additional resources were identified from bibliographies collected by the authors. DATA EXTRACTION: Relevant data were extracted independently by the authors. DATA SYNTHESIS: The important role of pharmacists in ensuring the quality of drugs dispensed to and handled/stored by patients is supported by business practices that (a) promote purchase of quality temperature-controlled drugs (including quality agreements with providers), (b) ensure appropriate handling and storage upon receipt, (c) ensure proper packaging for receipt by patients, (d) provide relevant information to patients, and (e) evaluate issues associated with possible compromised transit, handling, and storage of temperature-controlled drug products. CONCLUSION: The transit, handling, and storage of temperature-controlled drug products within complex supply chains provide opportunities for exposure of such drugs to temperatures above or below those recommended by the manufacturer. Pharmacists have opportunities to integrate business practices that facilitate the proper receipt, handling, and storage of temperature-controlled drug products. These practices will enhance the dispensing of high-quality, efficacious drug products to patients and proper handling and storage by patients.