District of Columbia Final Rule: Licensure of Pharmaceutical Detailers – Summary of Chapter 83, Title 17

By: Judy Fox, Senior Compliance Consultant
judyfox@cis-partners.com

The Director of the Department of Health for the District of Columbia (DC) has given notice of the adoption of a new chapter (83) of Title 17 (Business, Occupations and Professions) of the District of Columbia Municipal Regulations, entitled “Pharmaceutical Detailers”, which requires the licensure and regulation of the practice of pharmaceutical detailing in Washington, DC.

As of April 1, 2009, Pharmaceutical Detailers, more commonly known as pharmaceutical sales representatives, must hold a license to work in DC or risk a fine of up to ten thousand dollars ($10,000.00). In order to receive a license an applicant must: complete an application; submit two (2) recent passport-type photos and a photocopy of a government issued photo ID such as a driver’s license; submit a notarized statement attesting to the fact that the applicant agrees to abide by the requirements of pharmaceutical detailing including the code of ethics described in the law; and submit proof of graduating from an institute of higher education. (The Department of Health has made accommodations for an applicant that has worked as a pharmaceutical representative but is not a graduate by allowing a waiver for applicants who have worked fulltime as a representative for at least 12 months prior to March 26, 2008.) As the present ruling stands, after the initial licensing period, all licenses will expire at mid-night on the last day of February 2010 and at the same time on even numbered years thereafter.

In order to renew, reactivate or reinstate a license, an applicant must complete a minimum of fifteen (15) hours of approved continuing education during the two (2) year period proceeding the date the license will expire. The licensee will be required to attest to the completion of the continuing education and may be required to provide proof if requested to do so as part of an audit. To reactivate or reinstate an inactive license, the applicant would be required to submit proof of completing the continuing education credit within the two (2) year period preceding the date of the application, plus an additional eight (8) hours of continuing education credit for every year the license was inactive.

One continuing education credit is defined as a program of a minimum of fifty (50) minutes that provides instruction in one of the following areas: instructions in FDA laws and regulations pertaining to drug marketing, labeling and clinical trials; general medical and pharmaceutical terminology; professional ethics and pharmacology. Continuing education programs can be given through a variety of means including conferences, lectures, seminars or on the internet and can be offered through an accredited program provider, a governmental unit, a healthcare facility, a pharmaceutical company or an accredited institute of higher learning. The applicant is responsible for determining if a program is approved by the Board prior to attending the program. The Board allows for instructors, speakers, in-service training or publishing an article in a professional journal as alternative continuing education activities.

In addition to the requirements for continuing education, detailers will be required to retain documents and information regarding communications with healthcare professionals, the employees of healthcare professionals for five years. Retention of the records is addressed through the requirement that the Board be notified within ten (10) days of the end of the employment with the contact information of the contact person in the company who will be responsible for retrieving the records until the five years period is expired.

The final rule includes fees for the licensure and the provision for the Board to begin random audits of the licensed detailers after the year 2010.