Section 22-B10399. DEFINITIONS

 

10399.1As used in this chapter, the following terms and phrases shall have the meanings ascribed:

 

Adequate directions for use - directions under which the layman can use a device safely and for the purposes for which it is intended.  Directions for use may be inadequate because, among other reasons, of omission in whole or in part or incorrect specification of:

 

(a) Statements of all conditions, purposes, or uses for which the device is intended, including conditions, purposes, or uses for which it is prescribed, recommended, or suggested in its oral, written, printed, or graphic advertising, and conditions, purposes, or uses for which the device is commonly used; except that such statements shall not refer to conditions, uses, or purposes for which the device can be safely used only under the supervision of a practitioner licensed by law and for which it is advertised solely to such practitioner;

 

(b) Quantity of dose, including usual quantities for each of the uses for which it is intended and usual quantities for persons of different ages and different physical conditions;

 

(c) Frequency of administration and application;

 

(d) Duration of administration or application;

 

(e) Time of administration or application, in relation to time of meals, time of onset of symptoms, or other factors;

 

(f) Route or method of administration or application; and

 

(g) Preparation for use (for example, adjustment of temperature or other manipulation or process).

Chlorofluorocarbon - means any fully halogenated chlorofluoroalkane. 

 

Principal display panel – the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale, as it applies to over-the-counter devices in package form and as used in this chapter.

 

Propellant - means a liquefied or compressed gas that is used in whole or in part to expel from the same self-pressurized container or from a separate container a liquid or solid material different from the propellant, but the term does not include the use of a chlorofluorocarbon as an aerating agent for foamed or sprayed food products.

 

 

authority

Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor’s Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor’s Order 98-88, dated May 29, 1998.

source

Final Rulemaking published at 60 DCR 10252 (July 12, 2013).