2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8 - Prescription Drug Price Information › Subchapter IV-A - Definitions › § 48–804.51. Definitions

§ 48–804.51. Definitions.
For the purposes of this chapter, the term:
(1) “Agent” means an individual who:
(A) Is under the immediate and personal supervision of a prescriber or pharmacist and has written authorization, which shall be available for review upon request, to act on behalf of or at the direction of the prescriber or pharmacist when seeking or obtaining approval of a therapeutic interchange; or
(B) If not under the immediate and personal supervision of a prescriber or pharmacist, holds a license to administer drugs, such as a nurse, physician’s assistant, or other pharmacist.
(1A) "Biological product" shall have the same meaning as provided in 42 U.S.C. § 262.
(2) “Endorsing prescriber” means a prescriber who has reviewed the therapeutic interchange list and has notified the Boards of Pharmacy and Medicine in writing that he or she has agreed to allow the therapeutic interchange.
(2A) "Interchangeable biological product" means a biological product that is:
(A) Licensed and determined by the United States Food and Drug Administration to meet the standards for interchangeability under 42 U.S.C. § 262(k)(4); or
(B) Determined to be biosimilar to and interchangeable with a reference biological product as stated in the latest edition of, or supplement to, the United States and Food and Drug administration's ("FDA") publication, "Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations" (known as the Purple Book).
(3) “Issue date” means the 1st day of the 4th full calendar month after April 7, 1977, and the day following the end of each year after the 1st such issue date.
(4) “Most commonly used prescription drugs” means the prescription drug products that were most frequently paid for by the Medicaid program operated by the District of Columbia government under a state plan filed in accordance with section 1902 of the Social Security Act (§ 1396a of Title 42, United States Code), in the 3 consecutive months ending 60 days before an issue date.
(5) “Person” means any individual, partnership, corporation, organization, or association.
(6) “Pharmacy” means a pharmacy that provides services to the public on an outpatient basis.
(7) “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.
(8) “Substitute drug product” means a drug product different than the one originally prescribed by a prescriber.
(9) “Therapeutic interchange” means the dispensing of chemically dissimilar but therapeutically equivalent drug products.
(10) “Therapeutic interchange list” means a list of therapeutically equivalent drug products.
(11) “Therapeutically equivalent drug product” means a drug product that is chemically dissimilar but produces essentially the same therapeutic outcome.
(Sept. 10, 1976, D.C. Law 1-81, § 2, 23 DCR 2460; Apr. 7, 1977, D.C. Law 1-114, § 2, 23 DCR 8743; Mar. 11, 2010, D.C. Law 18-118, § 2(g), 57 DCR 901; Oct. 20, 2020, D.C. Law 23-133, § 2(a), 67 DCR 9880.)
Prior Codifications
1981 Ed., § 33-701.
1973 Ed., § 33-801.
Effect of Amendments
D.C. Law 18-118 rewrote the section.