Commissioner's Ruling - Exempt Distribution to Facilitate Humanitarian Relief Efforts in Response to the Haitian Natural Disaster of January 2010
January 22, 2010
Whereas, the New York State Department of Health is aware of the critical need to provide humanitarian aid, including medical care, to the people of Haiti to respond to the natural disaster befalling that country in January 2010, and the critical need for medical supplies, including controlled substances, to assist medical responders in providing care to the victims of that disaster; and
Whereas, it is not possible for all health care providers seeking to provide medical services in response to that disaster to obtain the controlled substances necessary to provide such care from a distributor or manufacturer of such substances in a timely fashion;
Now, Therefore, pursuant to the authority contained in Public Health Law Section 3321(1)(b), I hereby make the following ruling:
- Any health care provider otherwise authorized to possess, administer, or dispense controlled substances under New York State law may obtain such controlled substances from a pharmacy otherwise authorized to distribute such controlled substances for purposes of providing medical care in Haiti to victims of the Haitian natural disaster of January 2010.
- This ruling shall only apply to distribution of controlled substances. Distribution of other prescription medications are governed by the State Education Law.
- The pharmacy shall retain a record of any such distribution, including the name and United States Drug Enforcement Administration (DEA) number of the health care provider, the date of distribution, and the name, strength, dosage form and quantity of the controlled substance being requested and provided. Schedule II controlled substances shall be provided only on an official DEA 222 order form or any successor form and/or methodology authorized by the DEA, except where the DEA provides an exemption from such requirement.
- The pharmacy shall provide the health care provider with an itemized list of the drugs sold or transferred and shall include the name and address of the pharmacy, the DEA number of the pharmacy, the date of distribution and name, strength, dosage form and quantity of controlled substances being sold or transferred. Upon receipt of the controlled substance, the health care provider shall sign and date the itemized list of drugs sold or transferred and a statement 2 that they will be used for the purpose of providing medical care in Haiti only. The pharmacy shall report, within seventy-two hours, all such distributions to the Bureau of Narcotic Enforcement, New York State Department of Health, including the information listed above.
- The pharmacy and the health care provider shall maintain all required records of each such distribution in a separate file or in such a manner as will make them readily available for inspection by authorized representatives of the Bureau of Narcotic Enforcement, New York State Health Department and/or the United States DEA or other law enforcement officials authorized by law to inspect such records.
- This ruling shall only apply to distribution of controlled substances to health care providers who bring them to Haiti for the purpose of providing direct care to victims of the Haitian natural disaster of January 2010, where such distribution occurs between January 21, 2010 and March 2, 2010, inclusive.
Richard F. Daines, M.D.