Chapter 8E. Evaluation of Pharmaceutical Regulation.


  • Current through October 23, 2012
  • This chapter may be cited as the "SafeRX Evaluation Act of 2008".

    (Mar. 26, 2008, D.C. Law 17-131, § 501, 55 DCR 1659.)

    HISTORICAL AND STATUTORY NOTES

    Legislative History of Laws

    Law 17-131, the "SafeRx Amendment Act of 2008", was introduced in Council and assigned Bill No. 17-364 which was referred to the Committee on Health. The Bill was adopted on first and second readings on December 11, 2007, and January 8, 2008, respectively. Signed by the Mayor on February 1, 2008, it was assigned Act No. 17-282 and transmitted to both Houses of Congress for its review. D.C. Law 17-131 became effective on March 26, 2008.

    Delegation of Authority

    Delegation of Authority pursuant to D.C. Law 17-131, the SafeRX Amendment Act of 2008, see Mayor's Order 2008-94, July 3, 2008 (55 DCR 9375).

  • Current through October 23, 2012 Back to Top
  • For the purposes of this chapter, the term:

    (1) "Pharmaceutical product" shall have the same meaning as provided in § 3- 1201.02(10A)(B)(iii).

    (2) "Practice of pharmaceutical detailing" shall have the same meaning as provided in § 3-1201.02(10A).

    (Mar. 26, 2008, D.C. Law 17-131, § 502, 55 DCR 1659.)

    HISTORICAL AND STATUTORY NOTES

    Legislative History of Laws

    For Law 17-131, see notes following § 48-844.01.

  • Current through October 23, 2012 Back to Top
  • (a) Within 60 days of September 30, 2010, the Department of Health shall submit to the Council a comprehensive evaluation on the effectiveness of the SafeRx Amendment Act of 2008, effective March 26, 2008 (D.C. Law 17-131), which shall include:

    (1) The number of individuals licensed to engage in the practice of pharmaceutical detailing since March 26, 2008;

    (2) The number of applicants for licensure to engage in the practice of pharmaceutical detailing not approved by the Board of Pharmacy;

    (3) The number of applicants for licensure to engage in the practice of pharmaceutical detailing for whom the educational requirements were waived;

    (4) An assessment of the appropriateness and efficacy of the continuing education requirements established pursuant to D.C. Law 17-131;

    (5) The number of individuals identified as engaging in the practice of pharmaceutical detailing without a license;

    (6) The amount of fines levied against persons charged with engaging in the practice of pharmaceutical detailing without a license;

    (7) The total amount and origin of revenue deposited into the Board of Pharmacy Fund;

    (8) The total amount of funds deposited into the Board of Pharmacy Fund that were used for the administration of the duties of the Board of Pharmacy;

    (9) The number and types of penalties levied for failure to comply with the requirements of off-label use of medication as set forth in § 48-841.03;

    (10) The number and amount of fines levied for violations as a result of pharmaceutical companies offering gifts or remuneration in violation of § 48-842.03;

    (11) The number of persons who participated in the Pharmaceutical Education Program established by § 48-843.03;

    (12) An assessment of the quality and effectiveness of the Pharmaceutical Education Program based on an assessment of data gathered from those who participated in the program. The data may be gathered by surveying those who participated in the program, using an evaluative instrument developed for that purpose;

    (13) An assessment of the extent to which regulation of the practice of pharmaceutical detailing has improved the practice of selling, providing information about, or promoting a pharmaceutical product.

    (b) The evaluation may be used to determine if D.C. Law 17-131 should be repealed or amended.

    (Mar. 26, 2008, D.C. Law 17-131, § 503, 55 DCR 1659.)

    HISTORICAL AND STATUTORY NOTES

    Legislative History of Laws

    For Law 17-131, see notes following § 48-844.01.