Air Freight Center, Inc. — Hazardous Materials Safety Interpretation

Page 1• = U.S. Department of Transportation 400 Seventh St., S.W. Washington, D.C. 20590 Research and Special Programs Administration AUG 1 3 2001 Mr. William G. Warder Ref. No. 01-0168 Air Freight Center, Inc. Kansas City International Airport P.O. Box 20104 Kansas City, MO 64195 Dear Mr. Warder: This responds to your letter of June 26, 2001, regarding the classification of drugs or medicines as Consumer Commodity, ORM-D under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). Your questions have been paraphrased and answered as follows: Q1. May a drug or medicine used solely for animals be described as "Consumer Commodity, ORM- D?" Al. The answer is yes. The definition of "Consumer commodity" in § 171.8 states that the term includes drugs and medicines. This applies even if the drug or medicine is used solely on animals, provided it is listed in the U.S. Pharmacopeia. Q2. May raw materials (chemicals intended to become a drug or medicine) that are listed in the U.S. Pharmacopeia be described as "Consumer Commodity, ORM-D?" A2. The answer is no. The material must be in a form intended or suitable for sale and household use. In this scenario only materials that are in a final form as a drug or medicine qualify for shipment as Consumer Commodity, ORM-D. I hope this information is helpful. Sincerely dest shn A. Gal Transportation Regulations Specialist Office of Hazardous Materials Standards#

Page 21 AIr PHONE (816) 243-5535 FREIGHT KANSAS CITY INTERNATIONAL AIRPORT CENTER, INC. P.O. BOX 20104 KANSAS CITY, MO 64195 LaValle Mr. Edward T. Mazzullo, Director Office of Hazardous Materials Standards 8171.8c Research and Special Programs Administration US Department of Transportation 400 Seventh Street, S.W. Consumer Commodity Washington, D.C. 20590 01-0168 Monday, June 26, 2001 Dear Mr. Mazzullo, Subject: Request expansion of; DOT Letters of Interpretation \ 10/02/2000 171.8; Consumer Commodities, reclassification of drugs or medicines; animal. I have a client that manufacturers ANIMAL drugs rather than human drugs. Of course, the same PDA approval is necessary before these products can be marketed. They are also listed in the U.S.P. • First, does the "Consumer Commodity" term for drugs and medicines found in 171.8 apply to animal drugs and medicines? • Second, Are the raw materials, also listed in the U.S.P. as "drugs and medicines" subject to any restrictions beyond the requirements for "Consumer Commodities"? • Or - for my benefit, can any chemical intended to become a "drug or medicine" listed in the U.S.P., and which qualifies for reclassification as a "consumer commodity" be reclassified? William G. Warder, Agent#