(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.
(c) If a therapeutic interchange list is established pursuant to subsection (b) of this section:
(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.
(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.)
HISTORICAL AND STATUTORY NOTES
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."
Legislative History of Laws
For legislative history of D.C. Law 1-81, see Historical and Statutory Notes following § 48-804.51.
For legislative history of D.C. Law 1-114, see Historical and Statutory Notes following § 48-804.51.
Law 18-118, the "Prescription Drug Dispensing Practices Reform Act of 2009", was introduced in Council and assigned Bill No. 18-240, which was referred to the Committee on Health. The bill was adopted on first and second readings on November 3, 2009, and December 1, 2009, respectively. Signed by the Mayor on January 11, 2010, it was assigned Act No. 18-266 and transmitted to both Houses of Congress for its review. D.C. Law 18-118 became effective on March 11, 2010.
(a)(1) When a pharmacist receives a prescription for a brand name drug, the pharmacist may dispense a generically equivalent drug product that is listed in the Orange Book; provided, that the pharmacist shall dispense a generically equivalent drug product if requested by the purchaser, except as provided in § 48-803.03.
(2) If a generic substitution is made pursuant to this subsection, the pharmacist shall dispense the generically equivalent drug product in stock having the lowest cost to the person purchasing the drug product.
(b) When a pharmacist receives a prescription for a drug by generic name, the pharmacist shall dispense the listed product in stock that has the lowest cost to the person purchasing the drug product.
(c) Repealed.
(Sept. 10, 1976, D.C. Law 1-81, title III, § 302, 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(b), 57 DCR 901.)
HISTORICAL AND STATUTORY NOTES
Prior Codifications
1981 Ed., § 33-732.
1973 Ed., § 33-832.
Effect of Amendments
D.C. Law 18-118 rewrote the heading and section, which had read as follows:
§ 48-803.02. Dispensation of equivalent products by pharmacists--Conditions under which authorized; prices for prescribed drugs.
"(a)(1) When a pharmacist receives a prescription for a brand name drug, the pharmacist may dispense a generically equivalent drug product that is listed in the Orange Book; provided, that the pharmacist shall dispense a generically equivalent drug product if requested by the purchaser, except as provided in § 48-803.02.
"(2) If a generic substitution is made pursuant to this subsection, the pharmacist shall dispense the generically equivalent drug product in stock having the lowest cost to the person purchasing the drug product.
"(b) When a pharmacist receives a prescription for a drug by generic name, the pharmacist shall dispense the listed product in stock having the lowest current selling price.
"(c) Until the first promulgation of the formulary by the Department of Human Services, pharmacists licensed in the District shall have the same power which they had prior to September 10, 1976, to exercise their professional judgment in selecting the drug product to be dispensed."
Legislative History of Laws
For legislative history of D.C. Law 1-81, see Historical and Statutory Notes following § 48-804.51.
For legislative history of D.C. Law 1-114, see Historical and Statutory Notes following § 48-804.51.
For Law 18-118, see notes following § 48-803.01.
A pharmacist shall not dispense a:
(1) Substitute drug product if the person purchasing the drug product or the patient for whom it is intended indicates a preference for the drug product actually prescribed;
(2) Generically equivalent drug product pursuant to § 48-803.02 if:
(A) The prescriber writes on a prescription order, signed by the prescriber, in the prescriber's own handwriting "dispense as written" or "D.A.W." or a similar notation; provided, that checking or initialing a box preprinted or stamped on a prescription form shall not constitute an acceptable notation; or
(B) The prescriber, by telephone, expressly indicates that the prescription is to be dispensed as communicated and this indication is noted in the pharmacist's own handwriting in the manner provided in subparagraph (A) of this paragraph;
(3)(A) Therapeutically equivalent drug product unless:
(i)(I) The pharmacist or pharmacist's agent obtains prior approval from the prescriber or the prescriber's agent before the therapeutically equivalent drug product can be dispensed; or
(II) The therapeutically equivalent drug product is included on the therapeutic interchange list and the endorsing prescriber has given consent to the Boards of Pharmacy and Medicine to permit therapeutic interchange without prior approval;
(ii) The person purchasing the drug product provides consent to the therapeutic interchange;
(iii) The therapeutically equivalent drug product does not have a higher cost to the purchaser than the originally prescribed drug product; provided, that the pharmacist may dispense a more expensive therapeutically equivalent drug product if consent is provided by the purchaser; and
(iv) The dispensing pharmacist, or pharmacist's agent, has notified the prescriber or prescriber's agent of the specific drug and dose dispensed.
(B) A pharmacist shall not dispense a therapeutically equivalent drug product for a prescription refill of an antipsychotic, antidepressant, chemotherapy, antiretroviral, or immunosuppressive drug but shall dispense the drug as prescribed.
(Sept. 10, 1976, D.C. Law 1-81, title III, § 303, 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(c), 57 DCR 901.)
HISTORICAL AND STATUTORY NOTES
Prior Codifications
1981 Ed., § 33-733.
1973 Ed., § 33-833.
Effect of Amendments
D.C. Law 18-118 rewrote the section, which had read as follows:
"The pharmacist shall not dispense an equivalent drug product under § 48-803.02 if:
"(1) The person purchasing the drug product or the patient for whom it is intended indicates a preference for the drug product actually prescribed;
"(2) The prescriber, in the case of a written prescription order signed by the prescriber, writes in the prescriber's own handwriting 'dispense as written' or 'D.A.W.' or a similar notation. A procedure for checking or initialing a box, preprinted or stamped on a prescription form, will not constitute an acceptable notation;
"(3) The prescriber, in the case of a prescription communicated by telephone, expressly indicates the prescription is to be dispensed as communicated, and this indication is noted in the pharmacist's own handwriting in the manner provided in subsection (b) of this section."
Legislative History of Laws
For legislative history of D.C. Law 1-81, see Historical and Statutory Notes following § 48-804.51.
For legislative history of D.C. Law 1-114, see Historical and Statutory Notes following § 48-805.51.
For Law 18-118, see notes following § 48-803.01.
(a) An individual shall be notified of a drug substitution and provided the right to refuse the substitution prior to purchase of the substitute drug product.
(b)(1) The Department of Health shall create and distribute to all pharmacies signs that state in block letters not less than one inch in height: "This pharmacy may substitute a less expensive drug product that is equivalent to the one prescribed by your health care practitioner unless you request otherwise.
(2) Each pharmacy shall display the sign in a prominent place that has a clear and unobstructed public view at or near the place where prescriptions are dispensed.
(Sept. 10, 1976, D.C. Law 1-81, § 301, as added Mar. 11, 2010, D.C. Law 18-118, § 2(d), 57 DCR 901.)
HISTORICAL AND STATUTORY NOTES
Legislative History of Laws
For Law 18-118, see notes following § 48-803.01.
When a drug is substituted under this subchapter, the pharmacist shall record on the prescription form the drug substituted by name and manufacturer, and retain the form for inspection by District officials. The pharmacist shall also label the prescription container with the name of the drug substituted, unless the prescribing physician writes "do not label," or words of similar import, on the prescription, or, in communicating the prescription by telephone, orders that the container not be so labelled.
(Sept. 10, 1976, D.C. Law 1-81, title III, § 304, 23 DCR 2460; Mar. 11, 2010, D.C. Law 18-118, § 2(e), 57 DCR 901.)
HISTORICAL AND STATUTORY NOTES
Prior Codifications
1981 Ed., § 33-734.
1973 Ed., § 33-834.
Effect of Amendments
D.C. Law 18-118 substituted "this subchapter" for "§ 48-803.02".
Legislative History of Laws
For legislative history of D.C. Law 1-81, see Historical and Statutory Notes following § 48-804.51.
For Law 18-118, see notes following § 48-803.01.
(a) The substitution of drugs by a licensed pharmacist under this subchapter shall not constitute the practice of medicine. Nothing in this subchapter shall be construed as authorizing a pharmacist to prescribe any drug or medication.
(b) Substitution of drugs made in accordance with § 48-803.02 shall not constitute evidence of negligence or improper pharmacy practice if the substitution was made within reasonable and prudent pharmacy practice or if the prescribed and substituted drugs were generically equivalent drug products drugs as determined under this chapter.
(c) Failure of a licensed physician to specify that a specific brand is necessary for the particular patient shall not constitute evidence of negligence unless the physician had reasonable cause to believe that the health of the patient required the use of that brand and no other.
(Sept. 10, 1976, D.C. Law 1-81, title III, § 305, 23 DCR 2460; Apr. 7, 1977, D.C. Law 1-114, § 4(b), 23 DCR 8743; Mar. 11, 2010, D.C. Law 18-118, § 2(f), 57 DCR 901.)
HISTORICAL AND STATUTORY NOTES
Prior Codifications
1981 Ed., § 33-735.
1973 Ed., § 33-835.
Effect of Amendments
D.C. Law 18-118 rewrote subsec. (a); and, in subsec. (b), substituted "generically equivalent drug products" for "therapeutically equivalent". Prior to amendment, subsec. (a) read as follows:
"(a) The substitution of therapeutically equivalent drugs by a licensed pharmacist under § 48-803.02 shall not constitute the practice of medicine."
Legislative History of Laws
For legislative history of D.C. Law 1-81, see Historical and Statutory Notes following § 48-804.51.
For legislative history of D.C. Law 1-114, see Historical and Statutory Notes following § 48-804.51.
For Law 18-118, see notes following § 48-803.01.
