§ 48–803.01. Generically equivalent drug formulary; therapeutic interchange list.

(a) The formulary of generically equivalent drug products for the District of Columbia shall be the chemical and generic drugs contained in the Food and Drug Administration publication, “Approved Drug Products with Therapeutic Equivalence Evaluations,” including all updates issued by the Food and Drug Administration (“Orange Book”).

(b) The Boards of Pharmacy and Medicine may jointly establish a therapeutic interchange list.

(1) The Boards of Pharmacy and Medicine shall:

(A) Revise or supplement the therapeutic interchange list as necessary;

(B) Establish procedures to allow a prescriber to consent to the substitution of therapeutically equivalent drug products without prior approval based on the therapeutic interchange list; provided, that a prescriber be allowed to limit authorization to specific conditions or patients and that no prescriber be required for any reason to consent to participation in the therapeutic interchange list; and

(C) Establish and maintain a database, searchable in real time, of those prescribers who have consented to use of the therapeutic interchange list, including any restrictions based on specific conditions or patients; and

(2) The Department of Health shall distribute the therapeutic interchange list to all pharmacies licensed in the District and shall publish it regularly in the District of Columbia Register.

(d) The Board of Pharmacy and the Board of Medicine shall maintain a link on their websites to the current list of biological products determined by the FDA to be interchangeable with a specific biological product.

(Sept. 10, 1976, D.C. Law 1-81, title III, § 301, 23 DCR 2460; Apr. 7, 1977, D.C. Law 1-114, § 4(a), 23 DCR 8743; Mar. 11, 2010, D.C. Law 18-118, § 2(a), 57 DCR 901; Oct. 20, 2020, D.C. Law 23-133, § 2(b), 67 DCR 9880.)

Prior Codifications

1981 Ed., § 33-731.

1973 Ed., § 33-831.

Effect of Amendments

D.C. Law 18-118 rewrote the section, which had read as follows: “The Department of Human Services shall publish a formulary of drug products, with the chemical or generic name of each, that are determined to be therapeutically equivalent to specified brand name drug products. The Department shall determine the contents of the formulary only after recommendations are made by a committee of 9 members appointed by the Director of that Department. The committee shall consist of one licensed physician and one licensed pharmacist employed by the Department, 2 licensed physicians and 3 licensed pharmacists in private practice in the District, and 2 pharmacologists on the faculty of a university in the District. The recommendations of the committee shall require concurrence of a majority of the members of the committee. The committee’s recommendations shall be published in the District of Columbia Register as proposed regulations of the Department. The Department’s determinations shall be made in accordance with §§ 2-503, 2-504 and 2-505 and published in the District of Columbia Register as final regulations. The committee shall review the published formulary annually, or whenever an amendment to it appears necessary. The committee shall publish its 1st recommendations no later than 8 months after April 7, 1977.”