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May 24, 2016
FDA and CDC issue emergency dispensing orders for doxycycline and ciprofloxacin during anthrax exposures; draft guidance published
Under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), the FDA gained expanded authority to authorize use of medical countermeasures (MCMs) via emergency dispensing orders and Emergency Use Instructions - a speedier pathway than promulgation of an Emergency Use Authorization. Under a memorandum of agreement between FDA and the CDC, CDC may "facilitate the availability of streamlined information about the use of eligible, approved MCMs needed during public health emergencies ..."
In April, the FDA published a draft guidance on Emergency Use Authorization of Medical Products and Related Authorities, and replaced prior EUAs for doxycycline and ciprofloxacin with emergency dispensing orders. Emergency dispensing, which may include mass distribution at a Point of Dispensing (POD), allows delivery of approved MCMs during an actual emergency without individual prescriptions for each recipient when permitted by state law or in accordance with an order issued by FDA.
The new emergency dispensing orders allow use of "eligible doxycycline products" or "eligible ciprofloxacin products" to be dispensed for post-exposure prophylaxis of inhalational anthrax during an anthrax emergency. [USDHHA, FDA. Emergency Dispensing Orders, 2016 Apr 13; http://1.usa.gov/1Uc3nPH; USDHHS, FDA. Emergency Use Authorization of Medical Products and Related Authorities - (Draft) Guidance for Industry and Public Health Stakeholders; 2016 Apr 1; http://1.usa.gov/1sOFJkb]
2016 DPLXXVII Seminar
November 10-13, 2016