Chapter 8. Prescription Drug Price Information.
Subchapter I. Prescription Drug Price Posting.
§ 48–801.01. List of most commonly used prescription drugs.
Thirty days prior to each issue date, the Department of Human Services shall furnish to the Office of Consumer Protection a list of the 100 most commonly used prescription drugs.
§ 48–801.02. Posters to be furnished pharmacies; contents.
Ten days prior to each issue date, the Office of Consumer Protection shall furnish to each pharmacy in the District a poster suitable for display of a type style and size so as to be easily readable at a reasonable distance, which:
(1) Lists the 100 most commonly used prescription drugs in 2 commonly prescribed quantities, with space for the current selling price of each quantity;
(2) Lists professional and convenience services, with space for each pharmacy to indicate:
(A) Whether it offers each service; and
(B) The additional charge, if any, for that service;
(3) Contains a heading stating “OUR CURRENT PRESCRIPTION PRICES” and containing spaces for the insertion of the name and address of each pharmacy;
(4) Indicates in simple language that:
(A) The price of a prescription drug is often different at different pharmacies, and that the consumer may want to make a comparison on the cost of a prescription;
(B) The pharmacy may be able to substitute a less expensive drug which is therapeutically equivalent to the one prescribed by the consumer’s doctor, unless the consumer does not approve; and
(C) The consumer has the right to know the exact price of a prescription before it is filled; and
(5) Provides space for each pharmacy to indicate the eligibility and terms of any discount it offers on legend drugs.
§ 48–801.03. Completion and display of posters.
On and after each issue date, each pharmacy shall legibly post on the poster its current selling prices for the 100 most commonly used prescription drugs, the professional and convenience services it offers and the additional charges therefor, and the eligibility and terms of any discount it offers on prescription drugs. The completed poster shall be displayed prominently in the immediate vicinity of the prescription drug service area in such a manner as to be easily visible to consumers without having to obtain permission or assistance of an employee of the pharmacy.
§ 48–801.04. Quotation of prices, services and charges.
The current selling price of all prescription drugs (including those not required to be posted) dispensed by each pharmacy, and the pharmacy’s discounts and professional and convenience services and charges therefor, shall be available and be quoted, correctly and free of charge, by the pharmacy upon request identifying the name, strength, and quantity prescribed by a physician, whether the request is made in person, in writing or by telephone.
§ 48–801.05. Services and drugs to be furnished at prices posted; exception.
No pharmacy may fail to provide to any consumer the discounts and services stated on the poster, under the eligibility, price, and other terms there stated. Every sale of one of the 100 most commonly used prescription drugs, in a quantity and strength which requires the price of the drug to be posted, shall be at the posted price, unless a decrease in price is authorized by subchapter III of this chapter.
§ 48–801.06. Consumer information to reflect actual charges.
A pharmacy may charge any current selling price, discount, service availability or service charge, at any time; provided, that the poster and sources of consumer information are adjusted accordingly.
Subchapter II. Advertising.
§ 48–802.01. Interference with disclosure of price information prohibited.
No person may directly or indirectly prohibit, hinder or restrict or attempt to prohibit or restrict the disclosure by any pharmacy, government agency, or other person, of accurate price information regarding prescription drugs, including such disclosure made by means of advertisements in print or broadcast media, or by other means.
Subchapter III. Substitution of Therapeutically Equivalent Drugs.
§ 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.
(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.
(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.
§ 48–803.02. Dispensing of generically equivalent drug product or interchangeable biological product.
(a)(1) When a pharmacist receives a prescription for a brand name drug, the pharmacist may dispense a generically equivalent drug product or interchangeable biological product that is listed in the Orange Book; provided, that the pharmacist shall dispense a generically equivalent drug product or interchangeable biological 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 or interchangeable biological 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 or interchangeable biological product, the pharmacist shall dispense the listed product in stock that has the lowest cost to the person purchasing the drug product.
(c) Repealed.
§ 48–803.03. Dispensing of substitute drug products — conditions.
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 or interchangeable biological 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.
§ 48–803.03a. Dispensing of substitute drug products by pharmacists — notification of substitution.
(a) An individual shall be notified of a drug substitution, including an interchangeable biological product, 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.
§ 48–803.04. Dispensation of equivalent products by pharmacists — Recording and labeling required.
When a drug is substituted under this subchapter, including the substitution of an interchangeable biological product, 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.
§ 48–803.05. Dispensation of equivalent products by pharmacists — Consideration as practice of medicine or evidence of negligence; failure of physician to specify specific brand.
(a) The substitution of drugs by a licensed pharmacist under this subchapter, including the substitution of an interchangeable biological product 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 drugs products or an interchangeable biological product 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.
§ 48–803.06. Pharmacist notification to prescriber of substitution of interchangeable biological product.
(a) Within 5 business days after dispensing a biological product to a patient, the dispensing pharmacist or the pharmacist's designee shall communicate to the prescriber the specific biological product dispensed, including the name and manufacturer of the biological product; except, that this communication shall not be required if the FDA has not approved an interchangeable biological product for the biological product prescribed to the patient or a refill prescription is not changed from the biological product dispensed on the most recent filling of the prescription.
(b)(1) Except as provided under subsection (c) of this section, the communication required under subsection (a) of this section shall be provided by making an entry that is electronically accessible to the health care provider through:
(A) An interoperable electronic medical records system;
(B) An electronic prescribing technology; or
(C) A pharmacy benefits management system.
(2) Making an entry through a mechanism listed in paragraph (1) of this subsection shall be presumed to provide the communication to the prescriber required under subsection (a) of this section.
(c) If the mechanisms listed in subsection (b)(1) of this section are unavailable, the communication required under subsection (a) of this section may be provided by facsimile, telephone, electronic transmission, or other means.
(d) The requirements under subsections (a) through (c) of this section shall not apply to dispensing pharmacists or their designees at a health maintenance organization that operates as a group model for services furnished through internal pharmacy operations for members and patients of the health maintenance organization.
Subchapter IV. Enforcement.
§ 48–804.01. Violations of posting provisions.
(a) Any pharmacy which sells a legend drug in violation of § 48-801.03, § 48-801.04, or § 48-801.05 is liable to the buyer, or the provider or insurer of the buyer, for the full amount charged for the drug.
(b) Civil fines, penalties, and fees may be imposed as alternative sanctions for any infraction of the provisions of this subchapter, or any rules or regulations issued under the authority of this subchapter, pursuant to Chapter 18 of Title 2. Adjudication of any infraction of this subchapter shall be pursuant to Chapter 18 of Title 2.
§ 48–804.02. Restraints of trade.
Any person who, by any means, interferes with, prevents, discourages, or attempts to interfere with, prevent, or discourage: (1) any disclosure of, or attempt to disclose, or action necessary to disclose, substantially accurate prices, discounts, services, or other information concerning any prescription drug, whether or not such disclosure is authorized or directed in this chapter, or is through any media or other form of communication, or is made or to be made by any publisher, broadcaster, pharmacy, pharmacist, advertiser, drug manufacturer, wholesaler, or chain, government agency, or any other person; or (2) any retail drug price-setting, substitution, or marketing policy or action required, encouraged or permitted by, or consistent with this chapter; has committed a restraint of trade, and has caused a tortious injury in the District of Columbia as described in § 13-423(a)(3) and (4), and shall be liable for treble civil damages to each and every person (including a pharmacy or pharmacist), health insurer, and government agency the object of or injured by such interference, prevention, discouragement, or attempt to interfere, prevent, or discourage. Any action which jeopardizes in any way, or raises the net price of, the supply from manufacturers or wholesalers of drugs to any pharmacy, government agency, health insurer, or person providing or paying for a drug in the District may comprise such an interference, prevention, discouragement, or attempt.
§ 48–804.03. Inspection of pricing records and practices; cease and desist orders.
After reasonable notice, the Office of Consumer Protection may inspect the pricing records and practices of any pharmacy or other person, to assure compliance with this chapter. After appropriate notice and hearing, the Office may, if it finds that any person has violated this chapter, issue a cease and desist order against continued or future violation, and such other orders as may otherwise be within powers of that Office.
Subchapter IV-A. 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.
