Pharmacy Ambient Temperature and Medication Efficacy

How do I know those pills I just bought that were sitting on the shelf are still good?

In the previous, second piece of this series about temperature monitoring and best storage practices in retail pharmacies we looked at the shelf-life of food as it relates to ambient temperature inside the store. In general, shelf-stable food products including canned, bottled and packaged goods are designed to be stored below 85°F (30°C), ideally 70°F (21°C). But what about pharmaceuticals stored at ambient store temperatures, those bottles of pills, capsules, and tablets sitting there on the shelf?

When pharmaceutical companies develop medications, they examine many factors such as effective dose, side effects, how it needs to be administered (orally, injection, transdermal etc.), effects of overdose, safety, and efficacy. A significant amount of time is spent understanding the effects of storage on the preparation. These studies will determine if the medication is stable at room temperature, needs refrigeration or needs to be frozen, as well as degradation during such storage. How this applies to pharmacies takes us on a journey.

Fortunately room temperature pharmaceutical storage is subject to regulation in the U.S. The U.S. Food and Drug Administration (FDA) regulations in CFR 21 (CFR2111) defines stability testing for pharmaceutical manufacturers, and notes testing shall be used in determining appropriate storage conditions and expiration dates. (Section 211.166) In 21CFR205.50 the FDA guidelines for State Licensing of Wholesale Prescription Drug Distributors states that all facilities where prescription drugs are stored, warehoused, handled, marketed or displayed to be maintained properly. FDA wording follows in italic.

(c) Storage. All prescription drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs, or with requirements in the current edition of an official compendium, such as the United States Pharmacopeia/National Formulary (USP/NF). 

(1) If no storage requirements are established for a prescription drug, the drug may be held at "controlled" room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected.

(2) Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and/or logs shall be utilized to document proper storage of prescription drugs.

(3) The record keeping requirements in paragraph (f) of this section shall be followed for all stored drugs.

Pharmacy regulations are issued by each state. In general they refer to or mirror the FDA guidelines which often refer to manufacturer’s guidelines. In Massachusetts for example, 247CMR9.00, section 901(5) states, While on duty, a pharmacist shall be responsible for proper preservation and security of all drugs in the pharmacy or pharmacy department, including the proper refrigeration and storage of said drugs. Massachusetts 247CMR9.00 for wholesale druggists, section 7.04(3) states,

All prescription drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs, or with requirements in the current edition of an official compendium such as the United States Pharmacopoeia/National Formulary (USP/NF).

(b) If no storage requirements are established for a prescription drug, the drug may be held at "controlled"room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected. 

(c) appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and/or logs shall be utilized to document proper storage of prescription drugs.

(d) The record-keeping requirements in 247 CMR 7.04(6) shall be followed for all stored drugs.