Title 48 — Foods and Drugs.

Notwithstanding any provision of law to the contrary, information submitted to the Department pursuant to this subchapter is confidential and is not a public record. Data compiled in aggregate form by the Department for the purposes of reporting required by this subchapter is a p…

This subchapter may be enforced in a civil action brought by the Corporation Counsel. A manufacturer or labeler that fails to provide a report as required by this subchapter commits a civil violation for which a fine of $1,000 plus costs and attorney’s fees may be adjudged.

The Mayor is authorized to issue any rules necessary to implement the provisions of this subchapter.

The Department shall report to the committee of the Council having jurisdiction over health and human services matters on or before January 1, 2005 and on or before July 1, 2005 on the assessment of fees on manufacturers and labelers of prescription drugs.

This subchapter shall apply as of July 1, 2004.

This chapter may be cited as the “Off-Label Informed Consent Act of 2008”.

For the purposes of this chapter, the term: (1) “FDA” means the federal Food and Drug Administration. (2) “Off-label use” means the use of a prescription drug for human use to treat a condition that is not included in the labeling for that medication, as approved by the federal F…

Before prescribing, administering, or furnishing a prescription medication for an off-label use, a prescriber shall make every reasonable effort to: (1) Explain to the patient, in easily understood terms, that the medication is not within the uses approved for that medication by …

Failure to comply with this chapter may be used by a health-occupation board as a factor when determining licensure status for a prescriber; provided, that a prescriber shall not be subject to an adverse licensure action if the Board of Medicine determines that the prescribing, a…

This chapter may be cited as the “Medication Advisory Committee Receiving Gifts or Remuneration Prohibition Act of 2008”.

For the purposes of this chapter, the term: (1) “Medication advisory committee” means any committee or panel that is responsible for making recommendations or decisions regarding a formulary to be used by a health program administered by the government of the District of Columbia…

(a) A pharmaceutical company shall not offer a gift or remuneration of any kind to a member of a medication advisory committee. (b) A member of a medication advisory committee shall not accept a gift or remuneration of any kind from a pharmaceutical company. (c) Nothing in this s…

A violation of this chapter shall be punishable by a fine of $1,000 per violation.

This chapter may be cited as the “Pharmaceutical Education Program Establishment Act of 2008”.

For the purposes of this chapter, the term “pharmaceutical product” shall have the same meaning as provided in § 3-1201.02(10A)(B)(iii).

(a) There is established an evidence-based Pharmaceutical Education Program (“Program”) within the Department of Health. The Program shall: (1) Educate prescribers who participate in the District of Columbia Medicaid program, and other publicly funded, contracted, or subsidized h…

This chapter shall apply upon inclusion of its fiscal effect in an approved budget and financial plan.

This chapter may be cited as the “SafeRX Evaluation Act of 2008”.

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) [§ 3-1201.02(10A)(A)].

(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 licen…

For the purposes of this chapter, the term: (a)(1) “Health care facility” means a hospital, assisted living facility, nursing home, or institutional pharmacy. (2) “Institutional pharmacy” means that physical portion of a health care facility where drugs, devices, and other materi…

(a)(1) The Board of Pharmacy shall design a public education campaign to educate individuals on: (A) The importance of promptly disposing of unused pharmaceuticals to avoid accidental overdoses, medication errors, and household drug theft; (B) How disposing of pharmaceuticals by …

(a) Effective January 1, 2011, it shall be unlawful for a health care facility to dispose of any pharmaceutical product, used or unused, by flushing the product down a drain or by any other method that utilizes the public sewer system, except as authorized by the Mayor through ru…

(a) The Mayor, pursuant to subchapter I of Chapter 5 of Title 2 [§ 2-501 et seq.], shall issue rules to implement the provisions of § 48-851.03. The rules shall specify safe, secure, and environmentally sound methods for health care facilities to dispose of used and unused pharma…

For the purposes of this chapter, the term: (1) “Administer” shall have the same meaning as provided in § 48-901.02(1). (2) “Controlled substance” shall have the same meaning as provided in § 48-901.02(4). (3) “Controlled Substances Act” means Unit A of Chapter 9 of this title [§…

(a) There is established the Prescription Drug Monitoring Program within the Department. The Program shall: (1) Establish, maintain, and administer an electronic system to monitor the dispensing of covered substances; (2) Provide dispensers with a basic file layout to enable elec…

(a)(1) Each dispenser shall submit to the Program the required reporting information for each prescription dispensed for a covered substance within 24 hours after the covered substance is dispensed, unless otherwise established by the Director through rulemaking, but this does no…

A prescriber or dispenser authorized to access the information in the possession of the Program pursuant to this chapter may delegate, pursuant to regulations promulgated by the Director to implement the provisions of this section, such authority to up to 2 health care profession…

(a) All data, records, and reports relating to the prescribing and dispensing of covered substances to patients and any abstracts from such data, records, and reports that are in the possession of the Program pursuant to this chapter and any materials relating to the operation or…

(a) The Director may enter into written agreements with other prescription drug monitoring programs, or a third party, approved by the Director, that operates an interstate prescription drug monitoring exchange, for the purpose of interoperability and the mutual exchange of infor…

(a) The Director may establish through rulemaking: (1) Criteria for indicators of misuse; and (2) A method for analysis of data collected by the Program using the criteria for indicators of misuse. (b) Upon the development of the criteria and data analysis, the Director may, in a…

(a) The Director and the employees of the Department shall not be liable for any civil damages resulting from the accuracy or inaccuracy of any information reported, compiled, or maintained by the Program pursuant to this chapter. (b) The Director and the employees of the Departm…

(a) It shall be unlawful for any person having access to the confidential information in possession of the Program or any data or reports produced by the Program to disclose the confidential information except as provided in this chapter. Any person who discloses this confidentia…

The Director, pursuant subchapter I of Chapter 5 of Title 2 [§ 2-501 et seq.], shall issue rules to implement the provisions of this chapter, including the establishment of criteria for granting waivers to the reporting requirements set forth in this chapter.

[Repealed or reserved.]

As used in this chapter, the term: (a)(1) “Administer” means the direct application of a controlled substance, whether by injection, inhalation, ingestion, or any other means, to the body of a patient or research subject by: (A) A practitioner (or, in the practitioner’s presence,…

(a) The Mayor shall administer this chapter and, with provision for public notice and comment, may add substances to or delete or reschedule all substances enumerated in the schedules in § 48-902.04, § 48-902.06, § 48-902.08, § 48-902.10 or § 48-902.12 pursuant to subchapter I of…

The controlled substances listed or to be listed in the schedules in §§ 48-902.04, 48-902.06, 48-902.08, 48-902.10 and 48-902.12 are included by whatever official, common, usual, chemical, or trade name designated.

The Mayor shall place a substance in Schedule I if the Mayor finds that the substance: (a)(1) Has high potential for abuse; and (2) Has no accepted medical use in treatment in the United States or in the District of Columbia or lacks accepted safety for use in treatment under med…

The controlled substances listed in this section are included in Schedule I, unless and until removed therefrom pursuant to § 48-902.01: (a)(1) Unless specifically excepted or unless listed in another schedule, any of the following opiates, including their isomers, esters, ethers…

The Mayor shall place a substance in Schedule II if the Mayor finds that: (1) The substance has high potential for abuse; (2) The substance has currently accepted medical use in treatment in the United States or the District of Columbia, or currently accepted medical use, with se…

The controlled substances listed in this section are included in Schedule II unless and until removed therefrom pursuant to § 48-902.01: (1) Unless specifically excepted or unless listed in another schedule, any of the following substances, whether produced directly or indirectly…

The Mayor shall place a substance in Schedule III if the Mayor finds that: (1) The substance has a potential for abuse less than the substances listed in Schedules I and II; (2) The substance has currently accepted medical use in treatment in the United States or the District of …

(a) The controlled substances listed in this section are included in Schedule III, unless and until removed therefrom pursuant to § 48-902.01: (1) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any…

The Mayor shall place a substance in Schedule IV if the Mayor finds that: (1) The substance has a low potential for abuse relative to substances in Schedule III; (2) The substance has currently accepted medical use in treatment in the United States or the District of Columbia; an…

(a) The controlled substances listed in this section are included in Schedule IV, unless and until removed therefrom pursuant to § 48-902.01: (1) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any …

The Mayor shall place a substance in Schedule V if the Mayor finds that: (1) The substance has low potential for abuse relative to the controlled substances listed in Schedule IV; (2) The substance has currently accepted medical use in treatment in the United States or the Distri…

The controlled substances listed in this section are included in Schedule V unless and until removed therefrom pursuant to § 48-902.01. (1) Any compound, mixture, or preparation containing limited quantities of any of the following narcotic drugs, or salts thereof, which also con…

The Mayor shall revise and republish the schedules semiannually for 2 years from August 5, 1981, and thereafter annually. The published schedules may include the brand or trade names of the substances controlled.

(a) A controlled substances analogue shall, to the extent intended for human consumption, be treated for the purposes of any District of Columbia law as a controlled substance in Schedule I. (b) Except as provided in subsection (c) of this section, the term “controlled analogue” …