Code of the District of Columbia

Chapter 8B. Off-Label Informed Consent.

§ 48–841.01. Short title.

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

(Mar. 26, 2008, D.C. Law 17-131, § 201, 55 DCR 1659.)

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).

§ 48–841.02. Definitions.

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 Food and Drug Administration.

(3) “Prescriber” means a person who is licensed, registered, or otherwise authorized by the District to prescribe and administer prescription drugs for human use in the course of a professional practice.

(Mar. 26, 2008, D.C. Law 17-131, § 202, 55 DCR 1659; Mar. 25, 2009, D.C. Law 17-353, § 309(b), 56 DCR 1117.)

Effect of Amendments

D.C. Law 17-353, in par. (2), substituted “prescription drug for human use” for “prescription drug”; in par. (3), substituted “prescription drugs for human use” for “prescription drugs”.

§ 48–841.03. Off-label use of medication.

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 the FDA; and

(2) Provide the patient with information regarding the potential risks and side effects associated with using the medication for the off-label use.

(Mar. 26, 2008, D.C. Law 17-131, § 203, 55 DCR 1659.)

Section References

This section is referenced in § 48-844.03.

§ 48–841.04. Penalties.

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, administering, or furnishing of the prescription medication for the off-label use was clearly evidence-based and the common practice within the medical community.

(Mar. 26, 2008, D.C. Law 17-131, § 204, 55 DCR 1659.)