D.C. Municipal Regulations (Last Updated: September 13, 2017) |
Title 22. HEALTH |
SubTilte 22-B. PUBLIC HEALTH AND MEDICINE |
Chapter 22-B18. PRESCRIPTION DRUG MARKETING COSTS |
Section 22-B1800. MANNER OF REPORTING AND FILING FEE
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1800.1Beginning July 1, 2007, each manufacturer or labeler of prescription drugs, directly or indirectly distributed for dispensation in the District, that employs, directs or utilizes marketing representatives in the District shall file the annual report required by section 302 of the Act ("annual report") in the form and manner provided by the Director.
1800.2The annual report shall be filed with the Department by July 1st of each year and shall contain, for the previous calendar year, all of the information required by the Act and be accompanied by payment of the required filing fee.
1800.3Manufacturers and labelers shall use the date of the activity to assign a reporting period and where the activity spans between more than one reporting period the cost shall be prorated by each applicable reporting period.
1800.4Manufacturer and labeler grant amounts shall be reported for the period in which the money is provided and are not required to be allocated over the life of the grant.
1800.5For purposes of the annual report due July 1, 2007 only, manufacturers and labelers shall report the required information by quarters. If any or all of the data for the first three quarters of 2006 is not available, then the manufacturers and labelers may substitute an explanation of why the data is not available for the data itself.
1800.6In conjunction with filing the required annual report, each manufacturer or labeler shall pay to the Department the required filing fee of five thousand ($5,000), by mailing a check, made out to "D.C. Treasurer," to District of Columbia Department of Health, Chief Financial Officer, 825 North Capitol Street, N.E., Room 5100,Washington, D.C. 20002.
1800.7The Department may reduce the amount of the filing fee through rulemaking if the Department finds that its administrative costs are less than anticipated.