reglab/housing_qa huggingface dataset:
DC Code § 48-704 (2021)
2021 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

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.
DC Code § 48-705 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 7 - Drug Manufacture and Distribution Licensure|§ 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.
DC Code § 48-706 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 7 - Drug Manufacture and Distribution Licensure|§ 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.
DC Code § 48-707 (2021)
2021 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

(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.
DC Code § 48-708 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 7 - Drug Manufacture and Distribution Licensure|§ 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.
DC Code § 48-709 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 7 - Drug Manufacture and Distribution Licensure|§ 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.
DC Code § 48-710 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 7 - Drug Manufacture and Distribution Licensure|§ 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.
DC Code § 48-711 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 7 - Drug Manufacture and Distribution Licensure|§ 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.
DC Code § 48-712 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 7 - Drug Manufacture and Distribution Licensure|§ 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.
DC Code § 48-713 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 7 - Drug Manufacture and Distribution Licensure|§ 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.
DC Code § 48-714 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 7 - Drug Manufacture and Distribution Licensure|§ 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.
DC Code § 48-715 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 7 - Drug Manufacture and Distribution Licensure|§ 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.
DC Code § 48-841.01 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 8B - Off-Label Informed Consent|§ 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).
DC Code § 48-841.02 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 8B - Off-Label Informed Consent|§ 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”.
DC Code § 48-841.03 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 8B - Off-Label Informed Consent|§ 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.
DC Code § 48-841.04 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 8B - Off-Label Informed Consent|§ 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.)
DC Code § 48-842.01 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 8C - Medication Advisory Committees|§ 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.)
DC Code § 48-842.02 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 8C - Medication Advisory Committees|§ 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.)
DC Code § 48-842.03 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 8C - Medication Advisory Committees|§ 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.
DC Code § 48-842.04 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 8C - Medication Advisory Committees|§ 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.)
DC Code § 48-843.01 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 8D - Pharmaceutical Education Program|§ 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.)
DC Code § 48-843.02 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 8D - Pharmaceutical Education Program|§ 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.)
DC Code § 48-843.03 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 8D - 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.
DC Code § 48-843.04 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 8D - Pharmaceutical Education Program|§ 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.)
DC Code § 48-844.01 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 8E - Evaluation of Pharmaceutical Regulation|§ 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).
DC Code § 48-844.02 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 8E - Evaluation of Pharmaceutical Regulation|§ 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.)
DC Code § 48-844.03 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 8E - Evaluation of Pharmaceutical Regulation|§ 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.)
DC Code § 48-851.01 (2021)
2021 District of Columbia Code|Title 48 - Foods and Drugs|Chapter 8F - Safe Disposal of Unused Pharmaceuticals|§ 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).