Title 48 — Foods and Drugs.

This chapter shall not apply to any cosmetic unless the cosmetic is a drug as defined by § 201 of the Food, Drug and Cosmetic Act [21 U.S.C. § 321 ].

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.

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 prescriptio…

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…

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,…

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 …

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.

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 advertis…

(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 issue…

(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 purc…

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)…

(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 …

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…

(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 …

(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 sancti…

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 co…

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 ch…

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 direct…

The Council finds that: (1) Affordability is critical in providing access to prescription drugs for District of Columbia residents. (2) AccessRx enables the District to take steps to make prescription drugs more affordable for qualified District residents, thereby increasing the …

For the purposes of this chapter, the term: (1) “AccessRx” means the District of Columbia AccessRx program established by § 48-831.03. (2) “Average wholesale price” means the wholesale price charged for a specific commodity that is assigned by the drug wholesaler and is listed in…

(a) AccessRx is hereby established. AccessRx shall be administered by the Department, which shall utilize, among other things, manufacturer rebates, pharmacy discounts, and aggregate purchasing to reduce prescription drug prices. In addition, the Department shall investigate the …

The Department shall make every effort to reduce and contain the cost of prescription drugs purchased for publicly funded pharmaceutical assistance programs, including D.C. Medicaid, the D.C. Health Care Alliance, and the Department of Mental Health. These efforts shall include m…

A drug manufacturer or labeler that sells prescription drugs in the District through any publicly funded pharmaceutical assistance program shall enter into a rebate agreement with the Department under AccessRx. The rebate agreement shall require the manufacturer or labeler to mak…

(a) The Director of the Department shall negotiate the amount of the rebate required from a manufacturer or labeler in accordance with this subchapter. (b) The Director shall take into consideration the rebate calculated under the Medicaid Rebate Program pursuant to section 1927 …

(a) Participating retail pharmacies shall submit claims to the Department to verify the amount charged to qualified residents and to receive reimbursement. (b) The Department shall not impose transaction charges on participating retail pharmacies that submit claims or receive pay…

(a)(1) Upon receipt of the data from the Department, the manufacturer or labeler shall calculate the quarterly payment. If a discrepancy is discovered, the Department may, at its expense, hire a mutually agreed-upon independent auditor to verify the manufacturer’s calculation. If…

(a) The names of manufacturers and labelers who do and do not enter into rebate agreements pursuant to this subchapter are public information. The Department shall release this information to health care providers and the public on a regular basis. The Department also shall publi…

(a) The AccessRx Fund is established as a nonlapsing, dedicated fund, into which shall be deposited revenue from manufacturers and labelers that pay rebates pursuant to this subchapter and any appropriations or allocations designated for the AccessRx Fund, along with accruing int…

The Department shall: (1) Establish simplified procedures for determining eligibility and issuing AccessRx enrollment cards to qualified residents; (2) Undertake outreach efforts to build public awareness of AccessRx and maximize enrollment of qualified residents; and (3) Adjust …

The method of prescribing or ordering drugs may include, but is not limited to, the use of standard or larger prescription refill sizes in order to minimize operational costs and maximize economy. Unless the prescribing physician indicates otherwise, the use of the lowest cost ge…

The Department may contract with one or more third parties to administer any or all components of AccessRx, including outreach, eligibility, claims, administration, and rebate recovery and redistribution.

The Department may seek any waivers of federal law, rule or regulation necessary to implement the provisions of this chapter.

The Department shall submit a written report on the enrollment and financial status of AccessRx to the Council by the 2nd week of January each year.

The District may negotiate and enter into purchasing alliances and regional strategies with the governments of other jurisdictions, and with other public and private entities, for the purpose of reducing prescription drug prices for residents of the District.

The Mayor is authorized to issue any rules necessary to implement the provisions of this subchapter.

(a) The Department shall conduct a program to provide low-cost prescription and nonprescription drugs, medications, and medical supplies to low-income elderly individuals (“AccessRx for low-income elderly”). (b) The Director shall provide sufficient personnel to ensure efficient …

To be eligible, an individual shall: (1) Be a resident of the District; (2) Be at least 62 years of age; and (3) Have a household income that is not more than 200% of the federal poverty level.

(a) The Director shall establish the amount of payment to be made by eligible low-income elderly individuals toward the cost of prescription or nonprescription drugs, medications, and medical supplies furnished under AccessRx for low-income elderly; provided, that: (1) The total …

The Department shall conduct a program to negotiate low-cost prescription and nonprescription drugs, medications, and medical supplies for uninsured District residents (“AccessRx for uninsured”). The Director shall provide sufficient personnel to ensure efficient administration o…

To be eligible, an individual shall: (1) Be a resident of the District; (2) Have a household income that is not more than 350% of the federal poverty level; and (3) Not be enrolled in any public or private medical insurance program.

(a) Any participating retail pharmacy that sells prescription drugs covered by a rebate agreement pursuant to § 48-831.05 shall discount the retail price of those drugs sold to uninsured qualified residents. (b) The Department shall establish discounted prices for drugs covered b…

The Department shall conduct a program to provide life saving prescription and nonprescription medications and medical supplies by enrolling eligible individuals into pharmaceutical assistance programs. Of the funds appropriated for the Department of Health for fiscal year 2006, …

(a) To be eligible, an individual shall: (1) Be a resident of the District; (2) Have a household income not exceeding 300% of the federal poverty level; and (3) Lack prescription coverage. (b) Eligibility shall be determined by the contract organization administering the program.…

(a) A pharmacy benefits manager owes a fiduciary duty to a covered entity and shall discharge that duty in accordance with all applicable laws. In performance of that duty, a pharmacy benefits manager shall adhere to the practices set forth in this section. (b)(1) A pharmacy bene…

Compliance with the requirements of this subchapter is required in all contracts between a pharmacy benefits manager and a covered entity entered into in the District of Columbia or by a covered entity in the District of Columbia executed after May 18, 2004.

A violation of this subchapter is a violation of Chapter 39 of Title 28, for which a fine of not more than $10,000 may be adjudged.

A manufacturer or labeler of prescription drugs dispensed in the District that employs, directs, or utilizes marketing representatives in the District shall report marketing costs for prescription drugs in the District. These marketing costs shall be reported to the Department fo…

By July 1st of each year, a manufacturer or labeler of prescription drugs that directly or indirectly distributes prescription drugs for dispensation to residents of the District shall file a report with the Department in the form and manner provided by the Department. The report…

(a) Except as provided in subsection (b) of this section, the annual report filed pursuant to § 48-833.02 shall include the following information as it pertains to marketing activities conducted within the District in a form that provides the value, nature, purpose, and recipient…

By November 30th of each year, the Department shall provide an annual report, providing information in aggregate form, on prescription drug marketing expenses to the Council and the Corporation Counsel. By January 1, 2005, and every 2 years thereafter, the Department shall provid…