Interpretation Response #15-0142 ([Covington & Burling LLP.] [Mr. Thomas Brugato])
Below is the interpretation response detail and a list of regulations sections applicable to this response.
Interpretation Response Details
Response Publish Date:
Company Name: Covington & Burling LLP.
Individual Name: Mr. Thomas Brugato
Location State: DC Country: US
View the Interpretation Document
Response text:
May 17, 2016
Mr. Thomas Brugato
Covington & Burling LLP
One CityCenter
850 Tenth Street NW
Washington, DC 20001-495
Ref. No. 15-0142
Dear Mr. Brugato:
This letter is in response to your July 7, 2015 e-mail requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to medicines containing limited quantities of ethyl alcohol or ethanol. You ask whether Federal Drug Administration (FDA) regulated drugs which are transported for clinical trials or which must be dispensed to patients directly by doctors or similar healthcare professionals are considered “medicines” for the purposes of the exception provided in § 173.150(g). You also ask whether “medicines” must be “sold as retail products” to be transported under the exception provided in
§ 173.150(g).
As you are aware, final rule HM-233C, published March 18, 2014 [79 FR 15033] adopted DOT Special Permit 9275 (DOT-SP 9275) with modifications into the HMR in § 173.150(g). The intent of the rule was to limit the exception to consumer products containing ethyl alcohol. As adopted, the exception in § 173.150(g) applies to the following specific consumer products containing ethyl alcohol, “beverages, food, cosmetics, and medicines, medical screening solutions.” The final rule also provides an exception for ethyl alcohol contained in “concentrates sold as retail products.” The HMR does not define the terms beverages, food, cosmetics, or medicines. The word “medicine” is defined by the Merriam Webster’s dictionary as a “substance that is used in treating disease or relieving pain.” In accordance with § 173.22, it is the shipper's responsibility to properly classify a hazardous material. This Office does not generally perform that function.
However, it is the opinion of this Office that any medicines containing ethyl alcohol, including those intended for use in a clinical trial or administered to patients by healthcare professionals are eligible for the exception in § 173.150(g), provided all other requirements are met.
I trust this information is helpful. If you have further questions, please do not hesitate to contact this office.
Sincerely,
T. Glenn Foster
Chief, Regulatory Review and Reinvention Branch
Standards and Rulemaking Division
173.150(g), 173.22