Statutes, codes, and regulations
District Of Columbia Administrative Code
Title 22 - HEALTHSubtitle 22-B - PUBLIC HEALTH AND MEDICINE
Chapter 22-B18 - PRESCRIPTION DRUG MARKETING COSTS
Rule 22-B1899 - DEFINITIONS

D.C. Mun. Regs. tit. 22, r. 22-B1899

Download
PDF
Current through Register Vol. 71, No. 52, December 27, 2024
Rule 22-B1899 - DEFINITIONS
1899.1

As used in this Chapter the following terms shall have the meanings ascribed:

Act - AccessRx Act of 2004, effective May 18, 2004 (D.C. Law 15-164; D.C. Official Code § 48-831.01 et seq.)

Affiliate - any individuals, partnerships, corporations, joint ventures, companies, firms, contractors or other legal entities, if directly or indirectly, either one owns, controls or can control the other, or a third party owns, controls or can control both.

Council - Council of the District of Columbia

Department - Department of Health

Director - Director of the Department

Attorney General - Attorney General for the District of Columbia, formerly known as the Corporation Counsel.

GAAP - Generally Accepted Accounting Principles. A widely accepted set of rules, conventions, standards, and procedures for reporting financial information.

Independent survey research organization- a survey research organization, marketing research organization, or similar entity that is not owned or affiliated, directly or indirectly, with a pharmaceutical company, manufacturer, or labeler, and which does not share employees or independent contractors with a pharmaceutical company, manufacturer, or labeler.

Labeler - An entity or person that receives prescription drugs from a manufacturer or wholesaler and repackages those drugs for later retail sale and that has a labeler code from the federal Food and Drug Administration under 21 C.F.R. § 207.20.

Manufacturer - a manufacturer of prescription drugs and includes subsidiary or affiliate of a manufacturer.

Marketing Representative - an individual who is employed by or is under contract to represent a manufacturer or labeler and engages in the marketing of prescription drugs in the District to any person or entity licensed to provide health care in the District.

Trade secret - information, including a formula, pattern, compilation, program, device, method, technique, or process, that:

(A) Derives actual or potential independent economic value, from not being generally known to, and not being readily ascertainable by, proper means by another who can obtain economic value from its disclosure or use; and
(B) Is the subject of reasonable efforts to maintain its secrecy.

Wet signature - means a physically generated signature of a person that can be compared to other physically generated signatures of the person for verification of authenticity.

D.C. Mun. Regs. tit. 22, r. 22-B1899

Notice of Final Rulemaking published at 54 DCR 5287 (May 25, 2007); as amended by Notice of Final Rulemaking published at 59 DCR 535, 536 (January 27, 2012)
Authority: The Director of the Department of Health (Department), pursuant to § 307 of the District of AccessRx Act of 2004 , effective May 18, 2004 (D.C. Law 15-164; D.C. Official Code § 48-833.07 (2008 Repl.)) (the Act), and Mayor's Order 2006-60, dated June 7, 2006.