Larry M. Simonsmeier Writing Award
The American Society for Pharmacy Law (ASPL) is a nationwide organization with the purposes of: (i) furthering knowledge in the law related to pharmacists, pharmacies, the provision of pharmaceutical care, the manufacturing and distribution of drugs, and other food, drug, and medical device policy issues ("Pharmacy Law"); (ii) communicating accurate legal educational information; and (iii) providing education opportunities for pharmacists, attorneys, and others who are interested in Pharmacy Law.
ASPL recognizes outstanding scholarship related to Pharmacy Law with the Simonsmeier Award. The Award recognizes an outstanding paper relating to the interests of ASPL published during the prior two years (2013-2015). The 2016 Award includes an honorarium plus support for travel to the ASPL Developments in Pharmacy Law Seminar XXVII in Austin, Texas, November 9-13, 2016.
The Award is named in honor of the late Larry Simonsmeier (1944-2009), who was a pharmacist and attorney, professor and dean of Washington State University College of Pharmacy, president of ASPL, and editor of the Rx Ipsa Loquitur for more than twenty years.
Papers related to Pharmacy Law, as defined above, published in or accepted for publication in any English-language peer-reviewed journal (including law reviews) during the period from January 2013 through December 2015 are eligible. Interested parties are invited to nominate published papers written by themselves or other authors. Authors may submit manuscripts that are in press.
Submission of Nominations
Nominations should provide the name, address, daytime telephone number, and e-mail address of the nominator, a reprint of the full paper, and a complete journal citation for the paper being nominated. If an author is submitting a manuscript that is in press, the copy of the manuscript should be accompanied by documentation from the journal editor of the status of the paper, and should include contact information for the journal editor. The deadline for submission of nominations for the Larry M. Simonsmeier Award is June 30, 2016.
Nominations should be addressed to:
Education & Scholarship Committee
Questions may be directed to ASPL at:
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FDA and CDC issue emergency dispensing orders for doxycycline and ciprofloxacin during anthrax exposures; draft guidance published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