Dear Sir or Madam,
Thank you for the opportunity to provide comments on the Draft "Frequently Asked Questions: Licensure and Regulation of Pharmaceutical Detailers in the District of Columbia." The Biotechnology Industry Organization (BIO) appreciates the Board of Pharmacy's efforts in seeking to clarify the provisions of the regulations enacted pursuant to the SafeRx Amendment Act of 2008. However, BIO continues to have concerns regarding the interpretation and lack of clarity with regard to certain provisions of the law and regualtions. As addressed below, certain issues related to the applicability of the law and definition of "pharmaceutical detailer" remain ambiguous and some of these concerns previously communicated by BIO and other stakeholders have not been addressed by the Board.