reglab/statecodes huggingface dataset:
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter I - AccessRx › Part A - General › § 48–831.08. Discrepancies in rebate amounts

§ 48–831.08. Discrepancies in rebate amounts.
(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 discrepancy is still found, the manufacturer or labeler shall justify its calculation or make payments to the Department for any additional amount due. The manufacturer or labeler may, at its expense, hire a mutually agreed-upon independent auditor to verify the accuracy of the utilization data provided by the Department. If a discrepancy is discovered, the Department shall justify its data or refund any excess payment to the manufacturer or labeler.
(2) If the dispute over the rebate amount is not resolved, a request for a hearing with supporting documentation shall be submitted to the Office of Administrative Hearings. Failure to resolve the dispute may be cause for terminating the drug rebate agreement and denying payment to the manufacturer or labeler for any drugs.
(b) All prescription drugs of a manufacturer or labeler that enters into a rebate agreement that appear on the list of approved drugs shall be immediately available and the cost of the drugs shall be reimbursed, except as provided in this section.
(May 18, 2004, D.C. Law 15-164, § 108, 51 DCR 3688.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter I - AccessRx › Part A - General › § 48–831.09. Action with regard to nonparticipating manufacturers and labelers

§ 48–831.09. Action with regard to nonparticipating manufacturers and labelers.
(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 publicize participation by manufacturers and labelers that is of particular benefit to the public.
(b) The Department shall impose prior authorization requirements, as permitted by law, in all publicly funded pharmaceutical assistance programs to the extent the Department determines it is appropriate to do so in order to encourage manufacturer and labeler participation in AccessRx, as long as the additional prior authorization requirements remain consistent with the goals of the D.C. Medicaid program and Title 19 of the Social Security Act, approved July 30, 1965 (79 Stat. 343; 42 U.S.C. § 1396 et seq.).
(May 18, 2004, D.C. Law 15-164, § 109, 51 DCR 3688.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter I - AccessRx › Part A - General › § 48–831.10. AccessRx Fund

§ 48–831.10. AccessRx Fund.
(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 interest, to be used for the purposes specified in subsection (b) of this section.
(b) All funds in the AccessRx Fund, including any surplus or interest, shall be used to:
(1) Reimburse retail pharmacies for discounted prices provided to uninsured qualified residents pursuant to § 48-831.33;
(2) Pay benefits described in § 48-831.23; and
(3) Reimburse the Department for contracted services, including pharmacy claims processing fees, administrative and associated computer costs, and other reasonable program costs.
(c) The funds deposited in the AccessRx Fund shall not revert to the General Fund but shall continually be available for the uses designated in subsection (b) of this section, subject to authorization by Congress in an appropriations act.
(May 18, 2004, D.C. Law 15-164, § 110, 51 DCR 3688; Mar. 2, 2007, D.C. Law 16-191, § 88(a), 53 DCR 6794.)
Section References
This section is referenced in § 48-831.04.
Effect of Amendments
D.C. Law 16-191, in subsec. (b)(1), validated a previously made technical correction.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter I - AccessRx › Part A - General › § 48–831.11. Eligibility procedures

§ 48–831.11. Eligibility procedures.
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 requirements and terms of AccessRx to accommodate any new federally funded prescription drug program.
(May 18, 2004, D.C. Law 15-164, § 111, 51 DCR 3688.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter I - AccessRx › Part A - General › § 48–831.12. Method of prescribing or ordering drugs

§ 48–831.12. Method of prescribing or ordering drugs.
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 generic or chemically equivalent drugs is required; provided, that these drugs are of the same quality and have the same mode of delivery as is provided to the general public, consistent with good pharmaceutical practice.
(May 18, 2004, D.C. Law 15-164, § 112, 51 DCR 3688.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter I - AccessRx › Part A - General › § 48–831.13. Third-party administration

§ 48–831.13. Third-party administration.
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.
(May 18, 2004, D.C. Law 15-164, § 113, 51 DCR 3688.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter I - AccessRx › Part A - General › § 48–831.14. Waivers

§ 48–831.14. Waivers.
The Department may seek any waivers of federal law, rule or regulation necessary to implement the provisions of this chapter.
(May 18, 2004, D.C. Law 15-164, § 114, 51 DCR 3688.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter I - AccessRx › Part A - General › § 48–831.15. Annual summary report

§ 48–831.15. Annual summary report.
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.
(May 18, 2004, D.C. Law 15-164, § 115, 51 DCR 3688.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter I - AccessRx › Part A - General › § 48–831.16. Agreements with governments of other jurisdictions and other entities

§ 48–831.16. Agreements with governments of other jurisdictions and other entities.
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.
(May 18, 2004, D.C. Law 15-164, § 116, 51 DCR 3688.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter I - AccessRx › Part A - General › § 48–831.17. Rulemaking

§ 48–831.17. Rulemaking.
The Mayor is authorized to issue any rules necessary to implement the provisions of this subchapter.
(May 18, 2004, D.C. Law 15-164, § 117, 51 DCR 3688.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter I - AccessRx › Part B - AccessRx for the Elderly › § 48–831.21. Establishment of AccessRx for the low-income elderly

§ 48–831.21. Establishment of AccessRx for the low-income elderly.
(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 administration of the program. The extent and magnitude of the program shall be determined by the Director on the basis of the calculated need of the recipient population and the available funds.
(c) The Department may not spend more on this program than is available through appropriations from the General Fund, dedicated revenue, federal or other grants, and other established and committed funding sources. The Director may accept, for the purpose of carrying out this program:
(1) Federal funds appropriated under any federal law relating to the furnishing of free or low-cost drugs to elderly individuals, and may take such action as is necessary for the purposes of carrying out that federal law; and
(2) Funds that may be available from any other agency of government, individual, group, or corporation.
(May 18, 2004, D.C. Law 15-164, § 121, 51 DCR 3688.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter I - AccessRx › Part B - AccessRx for the Elderly › § 48–831.22. Eligibility for low-income elderly

§ 48–831.22. Eligibility for low-income elderly.
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.
(May 18, 2004, D.C. Law 15-164, § 122, 51 DCR 3688.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter I - AccessRx › Part B - AccessRx for the Elderly › § 48–831.23. Payment for drugs by low-income elderly

§ 48–831.23. Payment for drugs by low-income elderly.
(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 cost paid by the low-income elderly individual for any covered purchase of a prescription or nonprescription drug or medication provided under the basic component of AccessRx does not exceed 20% of the price allowed for that prescription under AccessRx rules, or $2, whichever is greater; and
(2) For the supplemental component of AccessRx, except as otherwise provided in this section, the total cost paid by the low-income elderly individual for any covered purchase of a prescription drug or medication shall not exceed 50% of the price allowed for that prescription under AccessRx.
(b) Prior to January 1, 2006, the Director shall establish annual limits on the costs incurred by eligible household members for prescription or nonprescription drugs or medications covered under AccessRx for low-income elderly. After the annual limits have been established, beginning on January 1, 2007, AccessRx for low-income elderly shall pay 80% of the cost of all prescription or nonprescription drugs or medications covered by the supplemental component of AccessRx. The limits shall be set by the Director by regulation as necessary to operate the program within the AccessRx for low-income elderly budget.
(May 18, 2004, D.C. Law 15-164, § 123, 51 DCR 3688.)
Section References
This section is referenced in § 48-831.07 and § 48-831.10.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter I - AccessRx › Part C - AccessRx for Uninsured Residents of the District of Columbia › § 48–831.31. Establishment of AccessRx for uninsured District residents

§ 48–831.31. Establishment of AccessRx for uninsured District residents.
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 of the program. The extent and magnitude of the program shall be determined by the Director on the basis of the calculated need of the recipient population and available funds.
(May 18, 2004, D.C. Law 15-164, § 131, 51 DCR 3688.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter I - AccessRx › Part C - AccessRx for Uninsured Residents of the District of Columbia › § 48–831.32. Eligibility of the uninsured

§ 48–831.32. Eligibility of the uninsured.
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.
(May 18, 2004, D.C. Law 15-164, § 132, 51 DCR 3688.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter I - AccessRx › Part C - AccessRx for Uninsured Residents of the District of Columbia › § 48–831.33. Discounted prices for uninsured qualified residents

§ 48–831.33. Discounted prices for uninsured qualified residents.
(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 by a rebate agreement and shall promote the use of efficacious and reduced-cost drugs, taking into consideration reduced prices for state and federally capped drug programs, differential dispensing fees, administrative overhead, and incentive payments.
(c) Beginning January 1, 2005, a participating retail pharmacy shall offer the initial discounted price.
(d) Beginning no later than October 1, 2005, a participating retail pharmacy shall offer the secondary discounted price, if available.
(May 18, 2004, D.C. Law 15-164, § 133, 51 DCR 3688.)
Section References
This section is referenced in § 48-831.06, § 48-831.07, and § 48-831.10.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter I - AccessRx › Part D - AccessRx Pharmaceutical Resource Center › § 48–831.41. Establishment of AccessRx Pharmaceutical Resource Center

§ 48–831.41. Establishment of AccessRx Pharmaceutical Resource Center.
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, the Director shall enter into a contract with the Archdiocesan Health Care Network, Catholic Charities in an amount up to $1.956 million to operate and administer the program and provide sufficient personnel to ensure appropriate oversight of the program.
(May 18, 2004, D.C. Law 15-164, § 141; as added Oct. 20, 2005, D.C. Law 16-33, § 5072, 52 DCR 7503; Mar. 2, 2007, D.C. Law 16-192, § 5062(b), 53 DCR 6899.)
Effect of Amendments
D.C. Law 16-192 substituted “in an amount up to $1.956 million” for “in the amount of $1.956 million”.
Emergency Legislation
For temporary (90 day) addition, see § 5072 of Fiscal Year 2006 Budget Support Emergency Act of 2005 (D.C. Act 16-168, July 26, 2005, 52 DCR 7667).
For temporary (90 day) amendment of section, see § 5062(b) of Fiscal Year 2007 Budget Support Emergency Act of 2006 (D.C. Act 16-477, August 8, 2006, 53 DCR 7068).
For temporary (90 day) amendment of section, see § 5062(b) of Fiscal Year 2007 Budget Support Congressional Review Emergency Act of 2006 (D.C. Act 16-499, October 23, 2006, 53 DCR 8845).
For temporary (90 day) amendment of section, see § 5062(b) of Fiscal Year 2007 Budget Support Congressional Review Emergency Act of 2007 (D.C. Act 17-1, January 16, 2007, 54 DCR 1165).
Short Title
Short title of subtitle H of title V of Law 16-33: Section 5071 of D.C. Law 16-33 provided that subtitle H of title V of the act may be cited as the AccessRx Amendment Act of 2005.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter I - AccessRx › Part D - AccessRx Pharmaceutical Resource Center › § 48–831.42. Eligibility

§ 48–831.42. Eligibility.
(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.
(c) Eligibility for District Medicaid, DC Healthcare Alliance, and other public programs shall be screened at the time an individual seeks to enroll in the program, and appropriate referrals shall be made to the Income Maintenance Administration in the Department of Human Services.
(May 18, 2004, D.C. Law 15-164, § 142; as added Oct. 20, 2005, D.C. Law 16-33, § 5072, 52 DCR 7503.)
Emergency Legislation
For temporary (90 day) addition, see § 5072 of Fiscal Year 2006 Budget Support Emergency Act of 2005 (D.C. Act 16-168, July 26, 2005, 52 DCR 7667).
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter II - Transparent Business Practices Among Pharmacy Benefits Managers › § 48–832.02. Compliance

§ 48–832.02. Compliance.
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.
(May 18, 2004, D.C. Law 15-164, § 202, 51 DCR 3688; Mar. 2, 2007, D.C. Law 16-192, § 5062(d), 53 DCR 6899.)
Effect of Amendments
D.C. Law 16-192 substituted “and a covered entity entered into in the District of Columbia or by a covered entity in the District of Columbia” for “and a covered entity”.
Emergency Legislation
For temporary (90 day) amendment of section, see § 2(c) of AccessRX Act Clarification Emergency Amendment Act of 2006 (D.C. Act 16-370, May 5, 2006, 53 DCR 4059).
For temporary (90 day) amendment of section, see § 5062(d) of Fiscal Year 2007 Budget Support Emergency Act of 2006 (D.C. Act 16-477, August 8, 2006, 53 DCR 7068).
For temporary (90 day) amendment of section, see § 5062(d) of Fiscal Year 2007 Budget Support Congressional Review Emergency Act of 2006 (D.C. Act 16-499, October 23, 2006, 53 DCR 8845).
For temporary (90 day) amendment of section, see § 5062(d) of Fiscal Year 2007 Budget Support Congressional Review Emergency Act of 2007 (D.C. Act 17-1, January 16, 2007, 54 DCR 1165).
Temporary Legislation
For temporary (225 day) amendment of section, see § 2(c) of AccessRx Act Clarification Temporary Amendment of Act of 2006 (D.C. Law 16-154, September 19, 2006, law notification 53 DCR 7926).
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter II - Transparent Business Practices Among Pharmacy Benefits Managers › § 48–832.03. Enforcement

§ 48–832.03. Enforcement.
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.
(May 18, 2004, D.C. Law 15-164, § 203, 51 DCR 3688; Mar. 2, 2007, D.C. Law 16-191, § 88(b), 53 DCR 6794.)
Effect of Amendments
D.C. Law 16-191 validated a previously made technical correction.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter III - Full Disclosure of Prescription Drug Marketing Costs › § 48–833.01. Requirement to disclose prescription drug marketing costs

§ 48–833.01. Requirement to disclose prescription drug marketing costs.
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 for the purposes of assisting the District in its role as a purchaser of prescription drugs and as an administrator of prescription drug programs, enabling the District to determine the scope of prescription drug marketing costs and their effect on the cost, utilization, and delivery of health care services, and furthering the role of the District as guardian of the public interest.
(May 18, 2004, D.C. Law 15-164, § 301, 51 DCR 3688.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter III - Full Disclosure of Prescription Drug Marketing Costs › § 48–833.02. Manner of reporting

§ 48–833.02. Manner of reporting.
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 shall be accompanied by payment of a fee, as set by the Department in rule, to support the work of the Department under this subchapter.
(May 18, 2004, D.C. Law 15-164, § 302, 51 DCR 3688.)
Section References
This section is referenced in § 48-833.03.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter III - Full Disclosure of Prescription Drug Marketing Costs › § 48–833.03. Content of annual report by manufacturer or labeler

§ 48–833.03. Content of annual report by manufacturer or labeler.
(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 of the expense:
(1) All expenses associated with advertising, marketing, and direct promotion of prescription drugs through radio, television, magazines, newspapers, direct mail, and telephone communications as they pertain to District residents;
(2) With regard to all persons and entities licensed to provide health care in the District, including health care professionals and persons employed by them in the District, carriers licensed under Title 31, health plans and benefits managers, pharmacies, hospitals, nursing facilities, clinics, and other entities licensed to provide health care in the District, the following information:
(A) All expenses associated with educational or informational programs, materials, and seminars, and remuneration for promoting or participating in educational or informational sessions, regardless of whether the manufacturer or labeler provides the educational or informational sessions or materials;
(B) All expenses associated with food, entertainment, gifts valued at more than $25, and anything provided to a health care professional for less than market value;
(C) All expenses associated with trips and travel; and
(D) All expenses associated with product samples, except for samples that will be distributed free of charge to patients; and
(3) The aggregate cost of all employees or contractors of the manufacturer or labeler who directly or indirectly engage in the advertising or promotional activities listed in paragraphs (1) and (2) of this subsection, including all forms of payment to those employees. The cost reported under this paragraph shall reflect only that portion of payment to employees or contractors that pertains to activities within the District or to recipients of the advertising or promotional activities who are residents of or are employed in the District.
(b) The following marketing expenses are not subject to the requirements of this subchapter:
(1) Expenses of $25 or less;
(2) Reasonable compensation and reimbursement for expenses in connection with a bona fide clinical trial of a new vaccine, therapy, or treatment; and
(3) Scholarships and reimbursement of expenses for attending a significant educational, scientific, or policy-making conference or seminar of a national, regional, or specialty medical or other professional association if the recipient of the scholarship is chosen by the association sponsoring the conference or seminar.
(May 18, 2004, D.C. Law 15-164, § 303, 51 DCR 3688.)
Section References
This section is referenced in § 48-831.02.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter III - Full Disclosure of Prescription Drug Marketing Costs › § 48–833.04. Department reports

§ 48–833.04. Department reports.
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 provide a report to the Council and the Corporation Counsel, providing information in aggregate form, containing an analysis of the data submitted to the Department, including the scope of prescription drug marketing activities and expenses and their effect on the cost, utilization, and delivery of health care services, and any recommendations with regard to marketing activities of prescription drug manufacturers and labelers.
(May 18, 2004, D.C. Law 15-164, § 304, 51 DCR 3688.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter III - Full Disclosure of Prescription Drug Marketing Costs › § 48–833.05. Confidentiality; public information

§ 48–833.05. Confidentiality; public information.
Notwithstanding any provision of law to the contrary, information submitted to the Department pursuant to this subchapter is confidential and is not a public record. Data compiled in aggregate form by the Department for the purposes of reporting required by this subchapter is a public record as long as it does not reveal trade information that is protected by District, state, or federal law.
(May 18, 2004, D.C. Law 15-164, § 305, 51 DCR 3688.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter III - Full Disclosure of Prescription Drug Marketing Costs › § 48–833.06. Penalty

§ 48–833.06. Penalty.
This subchapter may be enforced in a civil action brought by the Corporation Counsel. A manufacturer or labeler that fails to provide a report as required by this subchapter commits a civil violation for which a fine of $1,000 plus costs and attorney’s fees may be adjudged.
(May 18, 2004, D.C. Law 15-164, § 306, 51 DCR 3688.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter III - Full Disclosure of Prescription Drug Marketing Costs › § 48–833.07. Rulemaking

§ 48–833.07. Rulemaking.
The Mayor is authorized to issue any rules necessary to implement the provisions of this subchapter.
(May 18, 2004, D.C. Law 15-164, § 307, 51 DCR 3688.)
Delegation of Authority
Delegation of Authority Pursuant to D.C. Law 16-62, the AccessRx Act of 2004, see Mayor’s Order 2006-60, June 7, 2006 ( 53 DCR 5322).
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter III - Full Disclosure of Prescription Drug Marketing Costs › § 48–833.08. Report

§ 48–833.08. Report.
The Department shall report to the committee of the Council having jurisdiction over health and human services matters on or before January 1, 2005 and on or before July 1, 2005 on the assessment of fees on manufacturers and labelers of prescription drugs.
(May 18, 2004, D.C. Law 15-164, § 308, 51 DCR 3688.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter III - Full Disclosure of Prescription Drug Marketing Costs › § 48–833.09. Applicability date

§ 48–833.09. Applicability date.
This subchapter shall apply as of July 1, 2004.
(May 18, 2004, D.C. Law 15-164, § 309, 51 DCR 3688.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8B - Off-Label Informed Consent › § 48–841.01. Short title

§ 48–841.01. Short title.
This chapter may be cited as the “Off-Label Informed Consent Act of 2008”.
(Mar. 26, 2008, D.C. Law 17-131, § 201, 55 DCR 1659.)
Delegation of Authority
Delegation of Authority pursuant to D.C. Law 17-131, the SafeRX Amendment Act of 2008, see Mayor’s Order 2008-94, July 3, 2008 ( 55 DCR 9375).
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8B - Off-Label Informed Consent › § 48–841.02. Definitions

§ 48–841.02. Definitions.
For the purposes of this chapter, the term:
(1) “FDA” means the federal Food and Drug Administration.
(2) “Off-label use” means the use of a prescription drug for human use to treat a condition that is not included in the labeling for that medication, as approved by the federal Food and Drug Administration.
(3) “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.
(Mar. 26, 2008, D.C. Law 17-131, § 202, 55 DCR 1659; Mar. 25, 2009, D.C. Law 17-353, § 309(b), 56 DCR 1117.)
Effect of Amendments
D.C. Law 17-353, in par. (2), substituted “prescription drug for human use” for “prescription drug”; in par. (3), substituted “prescription drugs for human use” for “prescription drugs”.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8B - Off-Label Informed Consent › § 48–841.03. Off-label use of medication

§ 48–841.03. Off-label use of medication.
Before prescribing, administering, or furnishing a prescription medication for an off-label use, a prescriber shall make every reasonable effort to:
(1) Explain to the patient, in easily understood terms, that the medication is not within the uses approved for that medication by the FDA; and
(2) Provide the patient with information regarding the potential risks and side effects associated with using the medication for the off-label use.
(Mar. 26, 2008, D.C. Law 17-131, § 203, 55 DCR 1659.)
Section References
This section is referenced in § 48-844.03.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8B - Off-Label Informed Consent › § 48–841.04. Penalties

§ 48–841.04. Penalties.
Failure to comply with this chapter may be used by a health-occupation board as a factor when determining licensure status for a prescriber; provided, that a prescriber shall not be subject to an adverse licensure action if the Board of Medicine determines that the prescribing, administering, or furnishing of the prescription medication for the off-label use was clearly evidence-based and the common practice within the medical community.
(Mar. 26, 2008, D.C. Law 17-131, § 204, 55 DCR 1659.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8C - Medication Advisory Committees › § 48–842.01. Short title

§ 48–842.01. Short title.
This chapter may be cited as the “Medication Advisory Committee Receiving Gifts or Remuneration Prohibition Act of 2008”.
(Mar. 26, 2008, D.C. Law 17-131, § 301, 55 DCR 1659.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8C - Medication Advisory Committees › § 48–842.02. Definitions

§ 48–842.02. Definitions.
For the purposes of this chapter, the term:
(1) “Medication advisory committee” means any committee or panel that is responsible for making recommendations or decisions regarding a formulary to be used by a health program administered by the government of the District of Columbia.
(2) “Pharmaceutical company” means any entity that is engaged in, either directly or indirectly, the production, preparation, propagation, compounding, manufacturing, conversion or processing of a drug or biological product, including any person acting as its agent or representative.
(Mar. 26, 2008, D.C. Law 17-131, § 302, 55 DCR 1659.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8C - Medication Advisory Committees › § 48–842.03. Prohibition on gifts and remuneration

§ 48–842.03. Prohibition on gifts and remuneration.
(a) A pharmaceutical company shall not offer a gift or remuneration of any kind to a member of a medication advisory committee.
(b) A member of a medication advisory committee shall not accept a gift or remuneration of any kind from a pharmaceutical company.
(c) Nothing in this section shall prohibit the offering or acceptance of medication samples to members of a medication advisory committee who are licensed physicians engaged in the practice of medicine.
(Mar. 26, 2008, D.C. Law 17-131, § 303, 55 DCR 1659.)
Section References
This section is referenced in § 48-844.03.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8C - Medication Advisory Committees › § 48–842.04. Penalties

§ 48–842.04. Penalties.
A violation of this chapter shall be punishable by a fine of $1,000 per violation.
(Mar. 26, 2008, D.C. Law 17-131, § 304, 55 DCR 1659.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8D - Pharmaceutical Education Program › § 48–843.01. Short title

§ 48–843.01. Short title.
This chapter may be cited as the “Pharmaceutical Education Program Establishment Act of 2008”.
(Mar. 26, 2008, D.C. Law 17-131, § 401, 55 DCR 1659.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8D - Pharmaceutical Education Program › § 48–843.02. Definitions

§ 48–843.02. Definitions.
For the purposes of this chapter, the term “pharmaceutical product” shall have the same meaning as provided in § 3-1201.02(10A)(B)(iii).
(Mar. 26, 2008, D.C. Law 17-131, § 402, 55 DCR 1659.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8D - Pharmaceutical Education Program › § 48–843.03. Establishment of the Pharmaceutical Education Program

§ 48–843.03. Establishment of the Pharmaceutical Education Program.
(a) There is established an evidence-based Pharmaceutical Education Program (“Program”) within the Department of Health. The Program shall:
(1) Educate prescribers who participate in the District of Columbia Medicaid program, and other publicly funded, contracted, or subsidized health-care programs, on the therapeutic and cost-effective utilization of pharmaceutical products;
(2) Inform prescribers about pharmaceutical product marketing practices that are intended to circumvent competition from generic, other therapeutically-equivalent alternatives, or other evidence-based treatment options; and
(3) Utilize, or incorporate into the Program, other independent educational resources or models proven effective in promoting high-quality, evidenced-based, cost-effective information regarding the effectiveness and safety of pharmaceutical products.
(b) The Program shall be made available to prescribers who do not participate in the District of Columbia Medicaid program or other publicly funded, contracted, or subsidized health-care programs on a subscription basis.
(c) If approved by the Board of Medicine, the PE program may be used to satisfy continuing education requirements for the practice of medicine.
(Mar. 26, 2008, D.C. Law 17-131, § 403, 55 DCR 1659.)
Section References
This section is referenced in § 48-844.03.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8D - Pharmaceutical Education Program › § 48–843.04. Applicability

§ 48–843.04. Applicability.
This chapter shall apply upon inclusion of its fiscal effect in an approved budget and financial plan.
(Mar. 26, 2008, D.C. Law 17-131, § 404, 55 DCR 1659.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8E - Evaluation of Pharmaceutical Regulation › § 48–844.01. Short title

§ 48–844.01. Short title.
This chapter may be cited as the “SafeRX Evaluation Act of 2008”.
(Mar. 26, 2008, D.C. Law 17-131, § 501, 55 DCR 1659.)
Delegation of Authority
Delegation of Authority pursuant to D.C. Law 17-131, the SafeRX Amendment Act of 2008, see Mayor’s Order 2008-94, July 3, 2008 ( 55 DCR 9375).
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8E - Evaluation of Pharmaceutical Regulation › § 48–844.02. Definitions

§ 48–844.02. Definitions.
For the purposes of this chapter, the term:
(1) “Pharmaceutical product” shall have the same meaning as provided in § 3-1201.02(10A)(B)(iii).
(2) “Practice of pharmaceutical detailing” shall have the same meaning as provided in § 3-1201.02(10A) [§ 3-1201.02(10A)(A)].
(Mar. 26, 2008, D.C. Law 17-131, § 502, 55 DCR 1659.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8E - Evaluation of Pharmaceutical Regulation › § 48–844.03. Evaluation

§ 48–844.03. Evaluation.
(a) Within 60 days of September 30, 2010, the Department of Health shall submit to the Council a comprehensive evaluation on the effectiveness of the SafeRx Amendment Act of 2008, effective March 26, 2008 (D.C. Law 17-131), which shall include:
(1) The number of individuals licensed to engage in the practice of pharmaceutical detailing since March 26, 2008;
(2) The number of applicants for licensure to engage in the practice of pharmaceutical detailing not approved by the Board of Pharmacy;
(3) The number of applicants for licensure to engage in the practice of pharmaceutical detailing for whom the educational requirements were waived;
(4) An assessment of the appropriateness and efficacy of the continuing education requirements established pursuant to D.C. Law 17-131;
(5) The number of individuals identified as engaging in the practice of pharmaceutical detailing without a license;
(6) The amount of fines levied against persons charged with engaging in the practice of pharmaceutical detailing without a license;
(7) The total amount and origin of revenue deposited into the Board of Pharmacy Fund;
(8) The total amount of funds deposited into the Board of Pharmacy Fund that were used for the administration of the duties of the Board of Pharmacy;
(9) The number and types of penalties levied for failure to comply with the requirements of off-label use of medication as set forth in § 48-841.03;
(10) The number and amount of fines levied for violations as a result of pharmaceutical companies offering gifts or remuneration in violation of § 48-842.03;
(11) The number of persons who participated in the Pharmaceutical Education Program established by § 48-843.03;
(12) An assessment of the quality and effectiveness of the Pharmaceutical Education Program based on an assessment of data gathered from those who participated in the program. The data may be gathered by surveying those who participated in the program, using an evaluative instrument developed for that purpose;
(13) An assessment of the extent to which regulation of the practice of pharmaceutical detailing has improved the practice of selling, providing information about, or promoting a pharmaceutical product.
(b) The evaluation may be used to determine if D.C. Law 17-131 should be repealed or amended.
(Mar. 26, 2008, D.C. Law 17-131, § 503, 55 DCR 1659.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8F - Safe Disposal of Unused Pharmaceuticals › § 48–851.01. Definitions

§ 48–851.01. Definitions.
For the purposes of this chapter, the term:
(1) “Health care facility” means a hospital, assisted living facility, nursing home, or institutional pharmacy.
(2) “Institutional pharmacy” means that physical portion of a health care facility where drugs, devices, and other materials used in the diagnosis or treatment of injury, illness, and disease are dispensed, compounded, or distributed and pharmaceutical care is provided.
(3) “Pharmaceutical product” means a drug or biologic for human use regulated by the federal Food and Drug Administration.
(4) “Retail pharmacy” means a pharmacy that provides services to the public on an outpatient basis.
(Mar. 5, 2010, D.C. Law 18-112, § 2, 56 DCR 9378.)
Delegation of Authority
Delegation of Authority Pursuant to the Unused Pharmaceutical Safe Disposal Act of 2009, see Mayor’s Order 2011-90, May 6, 2011 ( 58 DCR 4176).
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8F - Safe Disposal of Unused Pharmaceuticals › § 48–851.02. Safe disposal of unused pharmaceuticals

§ 48–851.02. Safe disposal of unused pharmaceuticals.
(a)(1) The Board of Pharmacy shall design a public education campaign to educate individuals on:
(A) The importance of promptly disposing of unused pharmaceuticals to avoid accidental overdoses, medication errors, and household drug theft;
(B) How disposing of pharmaceuticals by flushing them into the public sewer system or throwing them in the trash can be harmful to the environment and can contaminate the drinking water supply; and
(C) How to dispose of unused pharmaceuticals in a safe and environmentally sound manner.
(2) Each retail pharmacy licensed in the District of Columbia shall implement the public education campaign as required by the Board of Pharmacy.
(b)(1) By July 1, 2010, the Board of Pharmacy shall make recommendations to the Mayor regarding the establishment of a program to enable consumers to dispose of unused pharmaceuticals, including controlled substances, in a safe and environmentally sound manner.
(2) In developing recommendations, the Board of Pharmacy shall give consideration to a mail-in program that:
(A) Utilizes prepaid mailing envelopes that allow an individual to mail unused pharmaceuticals to a single collection location approved for all pharmaceuticals including controlled substances;
(B) Distributes the prepaid mailing envelopes to the public at various locations, including to all retail pharmacies;
(C) Provides for the collected pharmaceuticals to be disposed of in a manner that is:
(i) Safe;
(ii) Secure;
(iii) Environmentally sound; and
(iv) In compliance with District and federal environmental requirements; and
(D) Randomly assesses the toxicity of pharmaceuticals received; provided, that the assessment results do not identify the:
(i) Patient;
(ii) Person who mailed the material;
(iii) Prescriber; or
(iv) Pharmacy.
(Mar. 5, 2010, D.C. Law 18-112, § 3, 56 DCR 9378.)
Section References
This section is referenced in § 48-851.04.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8F - Safe Disposal of Unused Pharmaceuticals › § 48–851.03. Disposal of pharmaceuticals by health care facilities

§ 48–851.03. Disposal of pharmaceuticals by health care facilities.
(a) Effective January 1, 2011, it shall be unlawful for a health care facility to dispose of any pharmaceutical product, used or unused, by flushing the product down a drain or by any other method that utilizes the public sewer system, except as authorized by the Mayor through rulemaking.
(b) A health care facility that is determined to have disposed of a pharmaceutical product in a manner prohibited by this chapter or by rules issued pursuant to this chapter shall be subject to a civil fine of up to $1,000 per occurrence and required to submit to the Board of Pharmacy a mitigation plan designed to prevent further occurrences.
(Mar. 5, 2010, D.C. Law 18-112, § 4, 56 DCR 9378.)
Section References
This section is referenced in § 48-851.04.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8F - Safe Disposal of Unused Pharmaceuticals › § 48–851.04. Rules

§ 48–851.04. Rules.
(a) The Mayor, pursuant to subchapter I of Chapter 5 of Title 2 [§ 2-501 et seq.], shall issue rules to implement the provisions of § 48-851.03. The rules shall specify safe, secure, and environmentally sound methods for health care facilities to dispose of used and unused pharmaceuticals.
(b) The Mayor, pursuant to subchapter I of Chapter 5 of Title 2 [§ 2-501 et seq.], may issue rules to implement the provisions of § 48-851.02.
(Mar. 5, 2010, D.C. Law 18-112, § 5, 56 DCR 9378.)
Editor's Notes
Revision of chapter: D.C. Law 4-29 enacted the District of Columbia Uniform Controlled Substances Act of 1981. D.C. Law 4-29 repealed former §§ 33-501, 33-503 to 33-513, 33-515 to 33-520, 33-521(a), (c) through (g), and 33-522 to 33-526 1981 Ed., redesignated former §§ 33-502, 33-514, and 33-521 1981 Ed. as present §§ 48-921.01, 48-921.02, and 48-931.01, respectively, and enacted present §§ 48-901.02, 48-902.01 to 48-902.13, 48-903.01 to 48-903.09, 48-904.01 to 48-904.10, 48-905.01 to 48-905.07, and 48-906.01 to 48-906.03. Former § 33-509 1981 Ed. had been amended by D.C. Law 4-25.
Former §§ 33-501 to 33-526 1981 Ed. as they existed prior to the revision of this chapter by D.C. Law 4-29, were part of the Uniform Narcotic Drug Act, approved June 20, 1938 (52 Stat. 785). D.C. Law 4-29 also repealed, inter alia, the provisions of former chapter 6 of this title, the Dangerous Drug Act for the District of Columbia, approved July 24, 1956 (70 Stat. 612).
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8F - Safe Disposal of Unused Pharmaceuticals › Subchapter II - Safe Disposal of Controlled Substances. [Repealed] › § 48–852.01. Definitions. [Repealed]

§ 48–852.01. Definitions. [Repealed]
Repealed.
(Apr. 11, 2019, D.C. Law 22-285, § 2, 66 DCR 1621; Nov. 13, 2021, D.C. Law 24-45, § 7173, 68 DCR 010163.)
Applicability
Applicability of D.C. Law 22-285: § 8 of D.C. Law 22-285 provided that the creation of this section by § 2 of D.C. Law 22-285 is subject to the inclusion of the law’s fiscal effect in an approved budget and financial plan. Therefore that amendment has not been implemented.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8F - Safe Disposal of Unused Pharmaceuticals › Subchapter II - Safe Disposal of Controlled Substances. [Repealed] › § 48–852.02. Safe disposal of controlled substances. [Repealed]

§ 48–852.02. Safe disposal of controlled substances. [Repealed]
Repealed.
(Apr. 11, 2019, D.C. Law 22-285, § 3, 66 DCR 1621; Nov. 13, 2021, D.C. Law 24-45, § 7173, 68 DCR 010163.)
Applicability
Applicability of D.C. Law 22-285: § 8 of D.C. Law 22-285 provided that the creation of this section by § 3 of D.C. Law 22-285 is subject to the inclusion of the law’s fiscal effect in an approved budget and financial plan. Therefore that amendment has not been implemented.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8F - Safe Disposal of Unused Pharmaceuticals › Subchapter II - Safe Disposal of Controlled Substances. [Repealed] › § 48–852.03. Collection by law enforcement. [Repealed]

§ 48–852.03. Collection by law enforcement. [Repealed]
Repealed.
(Apr. 11, 2019, D.C. Law 22-285, § 4, 66 DCR 1621; Nov. 13, 2021, D.C. Law 24-45, § 7173, 68 DCR 010163.)
Applicability
Applicability of D.C. Law 22-285: § 8 of D.C. Law 22-285 provided that the creation of this section by § 4 of D.C. Law 22-285 is subject to the inclusion of the law’s fiscal effect in an approved budget and financial plan. Therefore that amendment has not been implemented.