reglab/statecodes huggingface dataset:
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 6A - Third-party Food Delivery › § 48–656. Rules; enforcement

§ 48–656. Rules; enforcement.
(a) The Mayor, pursuant to subchapter I of Chapter 5 of Title 2, shall issue rules to implement this chapter.
(b)(1) A violation of this chapter, or rule issued pursuant to this chapter, shall be a violation of Chapter 39 of Title 28 enforceable by the Attorney General as an unfair or deceptive trade practice pursuant to § 28-3904.
(2) In addition to or in lieu of an enforcement action brought pursuant to paragraph (1) of this subsection, the Attorney General, in the name of the District of Columbia, shall have the exclusive authority to commence a civil action in the Superior Court of the District of Columbia, or any other court of competent jurisdiction, for damages in an amount not to exceed $5,000 or the amount of actual damages, whichever is greater, attorney fees and costs, and injunctive or other appropriate relief for a violation of this chapter.
(Mar. 10, 2023, D.C. Law 24-292, § 7, 70 DCR 898.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 7 - Drug Manufacture and Distribution Licensure › § 48–701. Definitions

§ 48–701. Definitions.
For the purposes of this chapter, the term:
(1) “Distribute” means:
(A) To sell any drug for resale;
(B) To act as a broker, agent, distributor, jobber, or wholesaler of any drug; or
(C) To otherwise negotiate a sale for the resale of any drug.
(2) “Drug” means any substance as defined under § 47-2885.02.
(3) “Manufacture” means:
(A)(i) To prepare, produce, propagate, compound, convert, process, or package a drug, either directly or indirectly, by extraction from a substance of natural origin, or independently by means of chemical synthesis;
(ii) Any packaging or repackaging of the substance or drug; or
(iii) Labeling or relabeling of any drug package or container to further distribution from the original place of manufacture to the person who makes final delivery, distribution, or sale to the ultimate consumer or user.
(B) “Manufacture” does not include the preparation or compounding of a drug by a pharmacist, practitioner, or any other authorized person who prepares or compounds a drug incidental to administering or dispensing a drug or conducting research, teaching, or chemical analysis on a drug in the course of professional practice.
(4) “Wholesaler” means any person, including but not limited to, a manufacturer, repackager, own label distributor, jobber, broker, agent, pharmacy, private label distributor, distributor warehouse, wholesale drug warehouse, independent wholesale drug trader, chain drug warehouse, retail pharmacy, or pharmacy that sells more than 5% of its drug inventory to a hospital or other pharmacy, which distributes a drug to a person other than a consumer or patient.
(5) “Conditional license” means a license issued pursuant to specific conditions.
(June 13, 1990, D.C. Law 8-137, § 2, 37 DCR 2631; Apr. 20, 1999, D.C. Law 12-264, § 36, 46 DCR 2118.)
Prior Codifications
1981 Ed., § 33-1001.
Delegation of Authority
Delegation of authority pursuant to D.C. Law 8-137, the “District of Columbia Drug Manufacture and Distribution Licensure Act of 1990”, see Mayor’s Order 98-88, May 29, 1998 ( 45 DCR 3982).
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 7 - Drug Manufacture and Distribution Licensure › § 48–702. Prohibitions

§ 48–702. Prohibitions.
No person shall:
(1) Manufacture, distribute, or wholesale any drug in the District of Columbia (“District”) unless the person holds a license or registration as required by this chapter issued by the Mayor to manufacture, distribute, or wholesale drugs;
(2) Manufacture, distribute, or wholesale in the District, any drug that is adulterated, misbranded, or otherwise unfit for use;
(3) Engage in manufacturing activities under a license issued pursuant to this chapter unless performed under the personal and immediate supervision of a pharmacist licensed by the District of Columbia or by an individual certified by the Mayor as having scientific or technical training or experience to perform the duties required to ensure that the licensed activity is conducted in a manner that will protect the public health and safety;
(4) Display, cause, permit to be displayed, or possess a cancelled, revoked, suspended, fictitious, or fraudulently altered license to manufacture, distribute, or wholesale drugs;
(5) Lend or transfer a license to manufacture, distribute, or wholesale drugs;
(6) Fail or refuse to surrender to the Mayor a license to manufacture, distribute, or wholesale a drug, if the license has been suspended, revoked, or cancelled, or if the manufacture, distribution, or wholesale activity has terminated;
(7) Permit an unlawful use of a license;
(8) Misrepresent or fail to state a material fact to the Mayor with respect to a license application or a licensee’s activities;
(9) Falsely represent to any person that he or she is licensed;
(10) Obtain a drug unless the drug is obtained legally from a legally authorized manufacturer, distributor, or wholesaler; or
(11) Violate any provision of this chapter, rules issued pursuant to this chapter, or any applicable federal or District law.
(June 13, 1990, D.C. Law 8-137, § 3, 37 DCR 2631.)
Prior Codifications
1981 Ed., § 33-1002.
Section References
This section is referenced in § 48-711.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 7 - Drug Manufacture and Distribution Licensure › § 48–703. License requirements

§ 48–703. License requirements.
(a) To obtain a license to manufacture, distribute, or wholesale any drug, any person who has a principal place of business in the District shall submit a completed application form with the required application fee to the Mayor and comply with the requirements of this chapter and the rules issued pursuant to this chapter.
(b) If a person manufactures, distributes, or wholesales any drug at more than one place of business in the District, the person shall apply for a separate license for each place of business.
(c) If a licensee manufactures, distributes, or wholesales a drug not listed on the application, the licensee shall notify the Mayor prior to the commencement of the activity.
(d) If a licensee ceases to manufacture, distribute, or wholesale any drug listed in the application, the licensee shall notify the Mayor of the change no later than 7 days after ceasing the activity.
(e) Each licensee shall maintain records as required by the Mayor, including but not limited to the quantities of each drug manufactured, distributed, or wholesaled daily and the name, address, purchaser, place of delivery, and quantity of any drug sold, transferred, or distributed by a licensee.
(f) Any license issued pursuant to this section shall be issued as a Public Health: Pharmacy and Pharmaceuticals endorsement to a basic business license under the basic business license system as set forth in subchapter I-A of Chapter 28 of Title 47.
(June 13, 1990, D.C. Law 8-137, § 4, 37 DCR 2631; Apr. 20, 1999, D.C. Law 12-261, § 2003(ff), 46 DCR 3142; Oct. 28, 2003, D.C. Law 15-38, § 3(ii), 50 DCR 6913.)
Prior Codifications
1981 Ed., § 33-1003.
Effect of Amendments
D.C. Law 15-38, in subsec. (f), substituted “Public Health: Pharmacy and Pharmaceuticals endorsement to a basic business license under the basic” for “Class A Public Health: Pharmacy and Pharmaceuticals endorsement to a master business license under the master”.
Emergency Legislation
For temporary (90 day) amendment of section, see § 3(ii) of Streamlining Regulation Emergency Act of 2003 (D.C. Act 15-145, August 11, 2003, 50 DCR 6896).
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 7 - Drug Manufacture and Distribution Licensure › § 48–704. Licensure of a drug manufacturer, distributor, or wholesaler

§ 48–704. Licensure of a drug manufacturer, distributor, or wholesaler.
The Mayor shall make available a license application form that requests:
(1) The name of the applicant and the address of the place of business for which the applicant seeks a license;
(2) If the applicant is a corporation, the name and address of each officer or director of the corporation and each stockholder who owns 10% or more of any one class of stock in the corporation or who owns 10% or more of the total stock of the corporation;
(3) If the applicant is a partnership or joint venture, the name and address of each partner or joint venturer. If a partner or joint venturer is a corporation, any information required pursuant to paragraphs (2) and (9) of this section shall be provided by the partner or joint venturer;
(4) A description of the activity for which the applicant seeks a license;
(5) A list of any drugs that the applicant proposes to manufacture, distribute, or wholesale in the District;
(6) Proof of current approval by the United States Food and Drug Administration for registration of producers of drugs and medical devices pursuant to § 510 of the Federal Food, Drug and Cosmetic Act (“Food, Drug and Cosmetic Act”), approved June 25, 1938 (52 Stat. 1040; 21 U.S.C. 360);
(7) If the applicant proposes to manufacture, distribute, or wholesale a controlled substance as defined in § 102 of the Drug Abuse Prevention and Control Act, approved October 27, 1970 (84 Stat. 1242; 21 U.S.C. 802), proof of current registration with the Mayor and the United States Drug Enforcement Administration;
(8) A valid certificate of occupancy; and
(9) A certificate of good standing from the Mayor if the applicant is a corporation.
(June 13, 1990, D.C. Law 8-137, § 5, 37 DCR 2631.)
Prior Codifications
1981 Ed., § 33-1004.
Editor's Notes
The reference to “§ 510 of the Federal Food, Drug and Cosmetic Act” appearing in (6) was corrected from “§ 360 of the Federal Food, Drug and Cosmetic Act” as it appeared in D.C. Law 8-137.
The reference to “§ 102 of the Drug Abuse Prevention and Control Act” appearing in (7) was corrected from “§ 802 of the Drug Abuse Prevention and Control Act” as it appeared in D.C. Law 8-137.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 7 - Drug Manufacture and Distribution Licensure › § 48–705. Renewal of license

§ 48–705. Renewal of license.
Prior to the expiration of a license, the Mayor shall mail a renewal notice to the licensee that includes:
(1) The expiration date of the current license;
(2) The date by which the renewal application must be received by the Mayor in order for the renewal license to be issued and mailed to the licensee before the licensee’s current license expires;
(3) The amount of the renewal fee; and
(4) Any other information the Mayor deems appropriate or necessary to renew the license.
(June 13, 1990, D.C. Law 8-137, § 6, 37 DCR 2631.)
Prior Codifications
1981 Ed., § 33-1005.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 7 - Drug Manufacture and Distribution Licensure › § 48–706. Conditional license

§ 48–706. Conditional license.
The Mayor may issue a conditional license to a person if the person does not meet all of the requirements of this chapter, the rules issued pursuant to this chapter, or any applicable federal law, provided the failure to meet the requirements does not endanger the health, safety, or welfare of the community, and the Mayor mandates that the requirements be met by a specific date.
(June 13, 1990, D.C. Law 8-137, § 7, 37 DCR 2631.)
Prior Codifications
1981 Ed., § 33-1006.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 7 - Drug Manufacture and Distribution Licensure › § 48–707. Registration of an out-of-state drug manufacturer, distributor, repackager, or wholesaler

§ 48–707. Registration of an out-of-state drug manufacturer, distributor, repackager, or wholesaler.
(a) An out-of-state drug manufacturer, distributor, or wholesaler who conducts distribution activities within the District shall register with the Mayor on a form prescribed by the Mayor, renew the registration as required by rule, and pay the required registration fee.
(b) A person registered to conduct distribution activities within the District shall be licensed or registered and in good standing under federal law and the laws of the state in which the person is incorporated or has a principal place of business.
(c) The Mayor may withdraw a registration for failure to maintain a license or registration in good standing under state or federal law.
(June 13, 1990, D.C. Law 8-137, § 8, 37 DCR 2631.)
Prior Codifications
1981 Ed., § 33-1007.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 7 - Drug Manufacture and Distribution Licensure › § 48–708. Inspections

§ 48–708. Inspections.
(a) The Mayor shall conduct an on-site inspection of an applicant’s facility before a license is granted.
(b) The Mayor, at any reasonable hour and consistent with constitutional guidelines, may enter a facility to conduct an announced or unannounced inspection of the facility to determine if the facility is in compliance with this chapter, the rules issued pursuant to this chapter, or any other District or locally enforceable federal law applicable to the manufacture, distribution, or wholesale of drugs.
(June 13, 1990, D.C. Law 8-137, § 9, 37 DCR 2631.)
Prior Codifications
1981 Ed., § 33-1008.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 7 - Drug Manufacture and Distribution Licensure › § 48–709. Summary action

§ 48–709. Summary action.
(a) If the Mayor determines that the conduct of a licensee presents an imminent danger to the health and safety of the residents of the District, the Mayor may suspend or revoke the license, or convert the license to a conditional license of the drug manufacturer, distributor, or wholesaler prior to a hearing.
(b) At the time of the suspension, revocation, or restriction of a license, the Mayor shall provide the licensee with written notice that states the action being taken, the basis for the action, and the right of the licensee to request a hearing.
(c) A licensee shall have the right to request a hearing within 3 days of service of notice of the suspension, revocation, or restriction of the license. The Mayor shall hold a hearing within 3 days of receipt of a timely request and shall issue a decision within 3 days of the hearing.
(d) The Mayor shall inform the licensee of the decision in writing and provide findings of fact and conclusions of law. The findings shall be supported by reliable, probative, and substantial evidence. The Mayor shall provide a copy of the decision to each party to a case or to his or her attorney of record.
(e) Any person aggrieved by a decision pursuant to this section may file an appeal with the Mayor within 10 days of the decision.
(June 13, 1990, D.C. Law 8-137, § 10, 37 DCR 2631.)
Prior Codifications
1981 Ed., § 33-1009.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 7 - Drug Manufacture and Distribution Licensure › § 48–710. Suspension, denial, or revocation

§ 48–710. Suspension, denial, or revocation.
(a) The Mayor may deny, suspend, or revoke a license, or convert the license to a conditional license, if the Mayor determines that:
(1) The person has violated a provision of this chapter, the rules issued pursuant to this chapter, or any other applicable federal or District law; or
(2) The person fraudulently or deceptively obtained or attempted to obtain a license in violation of this chapter, the rules issued pursuant to this chapter, or any other applicable federal or District law.
(b) The Mayor shall revoke any license issued pursuant to this chapter upon conviction of the licensee for a criminal violation of this chapter, the rules issued pursuant to this chapter, or any applicable federal law.
(June 13, 1990, D.C. Law 8-137, § 11, 37 DCR 2631.)
Prior Codifications
1981 Ed., § 33-1010.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 7 - Drug Manufacture and Distribution Licensure › § 48–711. Criminal action

§ 48–711. Criminal action.
A person who willfully violates § 48-702(1) is guilty of a misdemeanor, and, upon conviction, shall be fined not more than $5,000 for the first offense or $10,000 for the second or subsequent offense, imprisoned for not more than one year, or both. Each day that a violation continues is a separate violation under this chapter. The fines set forth in this section shall not be limited by § 22-3571.01.
(June 13, 1990, D.C. Law 8-137, § 12, 37 DCR 2631; June 11, 2013, D.C. Law 19-317, § 113(g), 60 DCR 2064.)
Prior Codifications
1981 Ed., § 33-1011.
Effect of Amendments
The 2013 amendment by D.C. Law 19-317 added the last sentence.
Emergency Legislation
For temporary (90 days) amendment of this section, see § 113(g) of the Criminal Fine Proportionality Emergency Act of 2013 (D.C. Act 20-45, April 1, 2013, 60 DCR 5400, 20 DCSTAT 1300).
Editor's Notes
Applicability of D.C. Law 19-317: Section 401 of D.C. Law 19-317 provided that the act shall apply only to offenses committed on or after June 11, 2013.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 7 - Drug Manufacture and Distribution Licensure › § 48–712. Civil infractions

§ 48–712. Civil infractions.
Civil fines, penalties, and fees may be imposed as sanctions for any violation of this chapter or the rules issued pursuant to this chapter, pursuant to Chapter 18 of Title 2.
(June 13, 1990, D.C. Law 8-137, § 13, 37 DCR 2631.)
Prior Codifications
1981 Ed., § 33-1012.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 7 - Drug Manufacture and Distribution Licensure › § 48–713. Cease and desist order; embargo

§ 48–713. Cease and desist order; embargo.
(a) If the Mayor determines that a hazardous condition exists that may endanger the health, safety, or welfare of the community, the Mayor may issue a cease and desist order to require a violator to cease operation immediately. Any person subject to a cease and desist order may appeal the cease and desist order within 7 days, excluding Saturdays, Sundays, and legal holidays, but shall be required to comply with the order pending appeal. The Mayor shall hold a hearing within 7 days of the receipt of a timely request and issue a decision within 7 days after the hearing.
(b) If the Mayor determines that a drug is adulterated or misbranded, the Mayor may order that the drug be removed from availability for distribution, sale, consumption, or use, or that the drug be destroyed or embargoed.
(June 13, 1990, D.C. Law 8-137, § 14, 37 DCR 2631.)
Prior Codifications
1981 Ed., § 33-1013.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 7 - Drug Manufacture and Distribution Licensure › § 48–714. Rules

§ 48–714. Rules.
(a) The Mayor shall issue rules pursuant to this chapter in accordance with the provisions of subchapter I of Chapter 5 of Title 2.
(b) The proposed rules shall include, but not be limited to:
(1) A schedule of license fees;
(2) Standards for the exemption of certain employees employed by a licensed manufacturer, distributor, or wholesaler;
(3) Procedures to govern the issuance, denial, renewal, suspension, conversion, or revocation of a license; and
(4) Standards pertaining to labeling, handling, recordkeeping, and storage.
(June 13, 1990, D.C. Law 8-137, § 15, 37 DCR 2631.)
Prior Codifications
1981 Ed., § 33-1014.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 7 - Drug Manufacture and Distribution Licensure › § 48–715. Exceptions

§ 48–715. Exceptions.
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 ].
(June 13, 1990, D.C. Law 8-137, § 16, 37 DCR 2631.)
Prior Codifications
1981 Ed., § 33-1015.
References in Text
Section 201 of the Food, Drug and Cosmetic Act is codified at 21 U.S.C. § 321.
Editor's Notes
The reference to “§ 201 of the Food, Drug and Cosmetic Act” was corrected from “§ 321 of the Food, Drug and Cosmetic Act” as it appeared in D.C. Law 8-137.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8 - Prescription Drug Price Information › Subchapter I - Prescription Drug Price Posting › § 48–801.01. List of most commonly used prescription drugs

§ 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.
(Sept. 10, 1976, D.C. Law 1-81, title I, § 101, 23 DCR 2460; Apr. 7, 1977, D.C. Law 1-114, § 3(a), 23 DCR 8743.)
Prior Codifications
1981 Ed., § 33-711.
1973 Ed., § 33-811.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8 - Prescription Drug Price Information › Subchapter I - Prescription Drug Price Posting › § 48–801.02. Posters to be furnished pharmacies; contents

§ 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.
(Sept. 10, 1976, D.C. Law 1-81, title I, § 102, 23 DCR 2460; Apr. 7, 1977, D.C. Law 1-114, § 3(c), 23 DCR 8743.)
Prior Codifications
1981 Ed., § 33-712.
1973 Ed., § 33-812.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8 - Prescription Drug Price Information › Subchapter I - Prescription Drug Price Posting › § 48–801.03. Completion and display of posters

§ 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.
(Sept. 10, 1976, D.C. Law 1-81, title I, § 103, 23 DCR 2460; Apr. 7, 1977, D.C. Law 1-114, § 3(a), (b), 23 DCR 8743.)
Prior Codifications
1981 Ed., § 33-713.
1973 Ed., § 33-813.
Section References
This section is referenced in § 48-804.01.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8 - Prescription Drug Price Information › Subchapter I - Prescription Drug Price Posting › § 48–801.04. Quotation of prices, services and charges

§ 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.
(Sept. 10, 1976, D.C. Law 1-81, title I, § 104, 23 DCR 2460; Apr. 7, 1977, D.C. Law 1-114, § 3(b), (d), 23 DCR 8743.)
Prior Codifications
1981 Ed., § 33-714.
1973 Ed., § 33-814.
Section References
This section is referenced in § 48-804.01.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8 - Prescription Drug Price Information › Subchapter I - Prescription Drug Price Posting › § 48–801.05. Services and drugs to be furnished at prices posted; exception

§ 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.
(Sept. 10, 1976, D.C. Law 1-81, title I, § 105, 23 DCR 2460; Apr. 7, 1977, D.C. Law 1-114, § 3(a), 23 DCR 8743.)
Prior Codifications
1981 Ed., § 33-715.
1973 Ed., § 33-815.
Section References
This section is referenced in § 48-804.01.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8 - Prescription Drug Price Information › Subchapter I - Prescription Drug Price Posting › § 48–801.06. Consumer information to reflect actual charges

§ 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.
(Sept. 10, 1976, D.C. Law 1-81, title I, § 106, 23 DCR 2460.)
Prior Codifications
1981 Ed., § 33-716.
1973 Ed., § 33-816.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8 - Prescription Drug Price Information › Subchapter II - Advertising › § 48–802.01. Interference with disclosure of price information prohibited

§ 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.
(Sept. 10, 1976, D.C. Law 1-81, title II, § 201, 23 DCR 2460.)
Prior Codifications
1981 Ed., § 33-721.
1973 Ed., § 33-821.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8 - Prescription Drug Price Information › Subchapter III - Substitution of Therapeutically Equivalent Drugs › § 48–803.02. Dispensing of generically equivalent drug product or interchangeable 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.
(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; Oct. 20, 2020, D.C. Law 23-133, § 2(c), 67 DCR 9880.)
Prior Codifications
1981 Ed., § 33-732.
1973 Ed., § 33-832.
Section References
This section is referenced in § 48-803.03 and § 48-803.05.
Effect of Amendments
D.C. Law 18-118 rewrote the section.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8 - Prescription Drug Price Information › Subchapter III - Substitution of Therapeutically Equivalent Drugs › § 48–803.03. Dispensing of substitute drug products — conditions

§ 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.
(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; Oct. 20, 2020, D.C. Law 23-133, § 2(d), 67 DCR 9880.)
Prior Codifications
1981 Ed., § 33-733.
1973 Ed., § 33-833.
Section References
This section is referenced in § 48-803.02.
Effect of Amendments
D.C. Law 18-118 rewrote the section.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8 - Prescription Drug Price Information › Subchapter III - Substitution of Therapeutically Equivalent Drugs › § 48–803.03a. Dispensing of substitute drug products by pharmacists — notification of substitution

§ 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.
(Sept. 10, 1976, D.C. Law 1-81, title III, § 301; as added Mar. 11, 2010, D.C. Law 18-118, § 2(d), 57 DCR 901; Oct. 20, 2020, D.C. Law 23-133, § 2(e), 67 DCR 9880.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8 - Prescription Drug Price Information › Subchapter III - Substitution of Therapeutically Equivalent Drugs › § 48–803.04. Dispensation of equivalent products by pharmacists — Recording and labeling required

§ 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.
(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; Oct. 20, 2020, D.C. Law 23-133, § 2(f), 67 DCR 9880.)
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”.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8 - Prescription Drug Price Information › Subchapter III - Substitution of Therapeutically Equivalent Drugs › § 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

§ 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.
(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; Oct. 20, 2020, D.C. Law 23-133, § 2(g), 67 DCR 9880.)
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.”
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8 - Prescription Drug Price Information › Subchapter III - Substitution of Therapeutically Equivalent Drugs › § 48–803.06. Pharmacist notification to prescriber of substitution of interchangeable biological product

§ 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.
(Sept. 10, 1976, D.C. Law 1-81, title III, § 306; as added Oct. 20, 2020, D.C. Law 23-133, § 2(h), 67 DCR 9880.)
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8 - Prescription Drug Price Information › Subchapter IV - Enforcement › § 48–804.01. Violations of posting provisions

§ 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.
(Sept. 10, 1976, D.C. Law 1-81, title IV, § 401, 23 DCR 2460; Mar. 8, 1991, D.C. Law 8-237, § 20, 38 DCR 314.)
Prior Codifications
1981 Ed., § 33-741.
1973 Ed., § 33-841.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8 - Prescription Drug Price Information › Subchapter IV - Enforcement › § 48–804.02. Restraints of trade

§ 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.
(Sept. 10, 1976, D.C. Law 1-81, title IV, § 402, 23 DCR 2460.)
Prior Codifications
1981 Ed., § 33-742.
1973 Ed., § 33-842.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8 - Prescription Drug Price Information › Subchapter IV - Enforcement › § 48–804.03. Inspection of pricing records and practices; cease and desist orders

§ 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.
(Sept. 10, 1976, D.C. Law 1-81, title IV, § 403, 23 DCR 2460.)
Prior Codifications
1981 Ed., § 33-743.
1973 Ed., § 33-843.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter I - AccessRx › Part A - General › § 48–831.01. Findings and declaration of intent

§ 48–831.01. Findings and declaration of intent.
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 overall health of District residents, promoting healthy communities, and protecting the public health and welfare.
(3) AccessRx can be integrated with any District-wide program for the uninsured.
(4) The intent of AccessRx is not to discourage employers from offering or paying for prescription drug benefits for their employees or to replace employer-sponsored prescription drug benefit plans that provide benefits comparable to those made available to qualified District residents under AccessRx.
(May 18, 2004, D.C. Law 15-164, § 101, 51 DCR 3688.)
Section References
This section is referenced in § 7-503.03.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter I - AccessRx › Part A - General › § 48–831.03. Establishment of AccessRx

§ 48–831.03. Establishment of AccessRx.
(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 purchase of prescription drugs from outside of the United States.
(b) The Department shall administer AccessRx and other medical and pharmaceutical assistance programs in a manner that is advantageous to the programs and to the enrollees in those programs. In implementing this subchapter, the Department may coordinate the other programs and AccessRx and may take actions to enhance efficiency, reduce the cost of prescription drugs, and maximize the benefits to the programs and enrollees, including providing the benefits of AccessRx to enrollees in other programs.
(May 18, 2004, D.C. Law 15-164, § 103, 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 I - AccessRx › Part A - General › § 48–831.04. Cost containment and savings with respect to existing publicly funded pharmaceutical programs

§ 48–831.04. Cost containment and savings with respect to existing publicly funded pharmaceutical programs.
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 manufacturer rebates, pharmacy discounts, and reductions through aggregate purchases, and may include importation of pharmaceuticals from outside of the United States. These savings shall be deposited in the AccessRx Fund established in § 48-831.10
(May 18, 2004, D.C. Law 15-164, § 104, 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 › § 48–831.05. Rebate agreement

§ 48–831.05. Rebate agreement.
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 make rebate payments to the District for deposit in the AccessRx Fund each calendar quarter or according to a schedule established by the Department.
(May 18, 2004, D.C. Law 15-164, § 105, 51 DCR 3688.)
Section References
This section is referenced in § 48-831.33.
2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 8A - Affordability of Prescription Drugs — AccessRx Program › Subchapter I - AccessRx › Part A - General › § 48–831.06. Rebate amount

§ 48–831.06. Rebate amount.
(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 of the Social Security Act, approved November 5, 1990 (104 Stat. 1388-143; 42 U.S.C. § 1396r-8), the average wholesale price of prescription drugs, and any other information on prescription drug prices and price discounts.
(c) The Director shall use the Director’s best efforts to obtain an initial rebate amount equal to or greater than the rebate calculated under the Medicaid program pursuant to 42 U.S.C. § 1396r-8.
(d) With respect to the rebate that takes effect on October 1, 2005 pursuant to § 48-831.33(d), the Director shall use the Director’s best efforts to obtain an amount equal to or greater than the amount of any discount, rebate, or price reduction for prescription drugs provided to the federal government. If the Department is not able to achieve the rebate amount described by this subsection, the Department shall report that fact to the standing committee of the Council having jurisdiction over the Department.
(May 18, 2004, D.C. Law 15-164, § 106, 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 › § 48–831.07. Operation of program

§ 48–831.07. Operation of program.
(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 payments under AccessRx.
(c) On a periodic basis, to be established by the Department, the Department shall reimburse a participating retail pharmacy for:
(1) The discounted price provided to uninsured qualified residents pursuant to § 48-831.33; and
(2) Prescription drugs dispensed to low-income elderly pursuant to § 48-831.23.
(d) The Department shall conduct ongoing quality assurance activities similar to those used in the D.C. Medicaid program.
(e) The Department shall collect utilization data from participating retail pharmacies submitting claims necessary to calculate the amount of the rebate from the manufacturer or labeler. The Department shall protect the confidentiality of all information subject to confidentiality protection under District or federal law, rule or regulation.
(May 18, 2004, D.C. Law 15-164, § 107, 51 DCR 3688.)