SECTION 291.15. Storage of Drugs

All drugs shall be stored at the proper temperature and conditions as defined by the following terms:

(1) Freezer--A place in which the temperature is maintained thermostatically between minus 25 degrees Celsius and minus 10 degrees Celsius (minus 13 degrees Fahrenheit and 14 degrees Fahrenheit).

(2) Cold--Any temperature not exceeding 8 degrees Celsius (46 degrees Fahrenheit). A refrigerator is a cold place in which the temperature is maintained thermostatically between 2 degrees Celsius and 8 degrees Celsius (36 degrees Fahrenheit and 46 degrees Fahrenheit).

(3) Cool--Any temperature between 8 degrees Celsius and 15 degrees Celsius (46 degrees Fahrenheit and 59 degrees Fahrenheit). An article for which storage in a cool place is directed may, alternatively, be stored and distributed in a refrigerator, unless otherwise specified by the individual monograph.

(4) Room temperature--The temperature prevailing in a working area.

(5) Controlled room temperature--A temperature maintained thermostatically between 15 degrees Celsius and 30 degrees Celsius (59 degrees Fahrenheit and 86 degrees Fahrenheit).

(6) Warm--Any temperature between 30 degrees Celsius and 40 degrees Celsius (86 degrees Fahrenheit and 104 degrees Fahrenheit).

(7) Excessive heat--Any temperature above 40 degrees Celsius (104 degrees Fahrenheit).

(8) Protection from freezing--Where, in addition to the risk of breakage of the container, freezing subjects a product to loss of strength or potency, or to destructive alteration of the dosage form, the container label bears an appropriate instruction to protect the product from freezing.

(9) Dry place--A place that does not exceed 40% average relative humidity at controlled room temperature or the equivalent water vapor pressure at other temperatures.

Source Note: The provisions of this §291.15 adopted to be effective September 7, 2008, 33 TexReg 7218