District of Columbia Administrative Code

10921 INSTITUTIONAL REVIEW BOARD APPROVAL 10921.1 An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all investigations covered by this part. 10921.2 If no IRB exists or if the Department finds that an IRB's review is i…

10922 INSTITUTIONAL REVIEW BOARD’S CONTINUING REVIEW 10922.1 The IRB shall conduct its continuing review of an investigation in accordance with 21 C.F.R., part 56. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Publi…

10923 SIGNIFICANT RISK DEVICE DETERMINATIONS 10923.1 If an IRB determines that an investigation, presented for approval under § 10901.2(a)(2), involves a significant risk device, it shall so notify the investigator and, where appropriate, the sponsor. A sponsor may not begin the …

10924 GENERAL RESPONSIBILITIES OF INVESTIGATORS 10924.1 An investigator is responsible for ensuring that an investigation is conducted according to the signed agreement, the investigational plan and applicable Department regulations, for protecting the rights, safety, and welfare…

10925 SPECIFIC RESPONSIBILITIES OF INVESTIGATORS 10925.1 An investigator may determine whether potential subjects would be interested in participating in an investigation, but shall not request the written informed consent of any subject to participate, and shall not allow any su…

10926 DISQUALIFICATION OF A CLINICAL INVESTIGATOR 10926.1 If the Department has information indicating that an investigator has repeatedly or deliberately failed to comply with the requirements of Chapter 109 or 21 C.F.R., parts 50 or 56, or has repeatedly or deliberately submitt…

10927 RECORDS 10927.1 A participating investigator shall maintain the following accurate, complete, and current records relating to the investigator's participation in an investigation: (a) All correspondence with another investigator, an IRB, the sponsor, a monitor, or the Depar…

10928 INSPECTIONS 10928.1 A sponsor or an investigator who has authority to grant access shall permit authorized Department employees, at reasonable times and in a reasonable manner, to enter and inspect any establishment where devices are held (including any establishment where …

10929 REPORTS 10929.1 An investigator shall prepare and submit the following complete, accurate, and timely reports: (a) An investigator shall submit to the sponsor and to the reviewing IRB a report of any unanticipated adverse device effect occurring during an investigation as s…

10999 DEFINITIONS 10999.1 As used in this chapter, the following terms shall have the meanings ascribed: Act – the Federal Food, Drug, and Cosmetic Act. approved June 25, 1938, 21 U.S.C. § 301, et seq. Custom device - a device that: (a) Necessarily deviates from devices generally…

1100 HEARING OFFICER 1100.1 Any hearing required by the Act or this chapter to be held by the Director may be conducted by the Director or a qualified hearing officer appointed by the Director. 1100.2 A hearing officer appointed by the Director shall have full authority to do the…

1101 HEARINGS AND NOTICES 1101.1 Except for an emergency suspension undertaken pursuant to §305(b)(1) of the Act, D.C. Code, 2001 Ed. §48-903.05, the Director shall give an applicant or registrant written notice and an opportunity to be heard prior to taking any final action whic…

1102 SUMMARY SUSPENSION AND DENIAL OR RENEWAL 1102.1 A hearing shall be convened within five (5) days of the institution of proceedings in the following cases: (a) Summary suspension; and (b) Denial or renewal. 1102.2 A registrant who has been summarily suspended or denied renewa…

1103 HEARING PROCEDURES 1103.1 Each hearing shall be open to the public. 1103.2 At each hearing, the hearing officer shall be present to hear the evidence. 1103.3 A person entitled to a hearing shall have the following rights: (a) The right to be represented by counsel; (b) The r…

1104 EXHIBITS AND OTHER DOCUMENTARY EVIDENCE 1104.1 When a written exhibit is offered in evidence, one (1) copy shall be furnished to each of the parties at the hearing unless the parties have been furnished previously with copies or the hearing officer directs otherwise. 1104.2 …

1105 OFFICIAL NOTICE 1105.1 Without limiting the discretionary powers of the hearing officer to notice other matters or documents which are properly the subject of official notice, the following matters may be officially noticed in all proceedings under the provisions of this cha…

1106 DISPOSITION OF CASES 1106.1 If a respondent fails to appear at any scheduled hearing after proper service of notice, the hearing officer in the absence of a continuance or good cause being shown, may proceed with the hearing and make a decision in the absence of respondent. …

1107 TRANSCRIPTS 1107.1 Hearings shall be recorded either stenographically or electronically and shall be available for transcribing upon the request of any party. 1107.2 The costs of transcripts of the record shall be borne by the parties requesting the transcripts. 1107.3 Chang…

1108 BURDEN OF PROOF 1108.1 In any proceeding resulting from proposed action to deny an applicant registration, the burden of proof shall be upon the applicant to demonstrate his or her qualifications. 1108.2 In any proceeding resulting from a proposed action to deny renewal or t…

1109 DECISIONS 1109.1 Within ten (10) days of the close of the hearing or as soon thereafter as it is practicable, the hearing officer shall notify the applicant or registrant of the proposed decision in the case. A copy of the notice shall be sent to the Director if the Director…

1110 MOTION FOR REHEARING OR RECONSIDERATION 1110.1 Motions for rehearing or reconsideration may be filed by respondent within ten (10) days of service of the proposed decision issued pursuant to §1109.1 of these rules. 1110.2 Motions for rehearing or reconsider shall be in writi…

1111 JUDICIAL REVIEW 1111.1 A person aggrieved by an adverse decision by the Director under this chapter may seek review in the District of Columbia Court of Appeals within fifteen (15) days of service of the decision of such other time as the court may prescribe for review of co…

1199 DEFINITIONS 1199.1 The provisions of §1099 of chapter 10 of this title and the definitions set forth in that section shall apply to this chapter. SOURCE: Final Rulemaking published at 33 DCR 1046 (February 21, 1986). AUTHORITY: DC-DCMR Unless otherwise noted, the authority f…

11100 AUTOMATED VENDING OPERATIONS NUTRITION STANDARDS 11100.1 Each Automated Vending Operation operator authorized to install an Automated Vending Operation in a District of Columbia Facility shall provide a sign in close proximity to each installed Automated Vending Operation t…

11101 STANDARDS FOR FOOD AND BEVERAGES PROVIDED AT MEETINGS AND EVENTS 11101.1 All food and beverage items purchased for meetings and events held at a District of Columbia Facility must be labeled with calories per serving as sold (or calories per measure provided for salad bar-t…

11102 PHYSICAL ACTIVITY BREAKS 11102.1 In order to promote physical activity, physical activity breaks may be offered during meetings. Halfway through meetings lasting more than one (1) hour, meeting leaders can choose to hold a five (5)- to ten (10)-minute physical activity brea…

11199 DEFINITIONS 11199.1 When used in this section, the following terms shall have the meanings ascribed: Added Sugars - Sugars that are either added during the processing of foods, or are packaged as such, and include sugars (free, mono- and disaccharides), sugars from syrups a…

1200 PURPOSE 1200.1 This chapter shall comprise all the enumerated schedules of controlled substances under the District of Columbia Uniform Controlled Substances Act of 1981 (Act), effective August 5, 1981 (D.C. Law 4-29; D.C. Official Code § 48-902.01), and all final rulemaking…

1201 SCHEDULE I ENUMERATED 1201.1 The controlled substances listed in this section are included in Schedule I of the Act unless removed therefrom pursuant to Section 201 of the Act: Opiates: Unless specifically excepted or unless listed in another schedule, any of the following o…

1202 SCHEDULE II ENUMERATED 1202.1 The controlled substances listed in this section are included in Schedule II of the Act unless removed therefrom pursuant to Section 201 of the Act: Unless specifically excepted or unless listed in another schedule, any of the following substanc…

1203 SCHEDULE III ENUMERATED 1203.1 The controlled substances listed in this section are included in Schedule III of the Act unless removed therefrom pursuant to Section 201 of the Act: Schedule III shall consist of the following controlled substances by whatever official name, c…

1204 SCHEDULE IV ENUMERATED 1204.1 The controlled substances listed in this section are included in Schedule IV of the Act unless removed therefrom pursuant to Section 201 of the Act. Schedule IV shall consist of the following controlled substances: (a) Depressants: Unless specif…

1205 SCHEDULE V ENUMERATED 1205.1 The following controlled substances listed below are included in Schedule V of the Act unless removed therefrom pursuant to Section 201 of the Act: Narcotic drugs containing non-narcotic active medicinal ingredients: Any compound, mixture, or pre…

1300 GENERAL PROVISIONS 1300.1 This chapter shall apply to all categories of prescriptions drugs. 1300.2 Unless otherwise prohibited in this chapter or by District or federal law, a pharmacist may accept as valid for dispensing, a written prescription, an oral prescription, a tel…

1301 WRITTEN PRESCRIPTION ORDERS 1301.1 In addition to conforming to all applicable federal and District requirements, a written prescription drug order shall contain the following: (a) The printed or typed full name, address, and telephone number of the practitioner; (b) The ori…

1302 ORAL PRESCRIPTION ORDERS 1302.1 A pharmacist shall not dispense an oral prescription drug order for a controlled substance listed in Schedule II except as provided in § 1306.5 of this chapter. 1302.2 An oral prescription drug order from a practitioner or a practitioner's des…

1303 TELEPHONE FACSIMILE PRESCRIPTION ORDERS 1303.1 A practitioner shall not transmit a prescription via telephone facsimile if in doing so it would interfere with a patient's freedom to choose a pharmacy, or without a patient's consent. 1303.2 A pharmacist shall not dispense a t…

1304 ELECTRONIC PRESCRIPTION ORDERS 1304.1 A practitioner shall not electronically transmit a prescription if in doing so it would interfere with a patient's freedom to choose a pharmacy, or without a patient's consent. 1304.2 A pharmacist shall not dispense an electronic prescri…

1305 ISSUANCE OF CONTROLLED SUBSTANCE PRESCRIPTIONS 1305.1 The prescribing practitioner and the pharmacist shall be jointly responsible for compliance with this chapter in prescribing and dispensing a controlled substance. 1305.2 A prescription for a controlled substance shall be…

1306 PRESCRIPTIONS FOR CONTROLLED SUBSTANCES LISTED IN SCHEDULE II 1306.1 Except as otherwise authorized in this section, a controlled substance listed in Schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, shall only be dispens…

1307 PARTIAL FILLING OF PRESCRIPTIONS LISTED IN SCHEDULE II 1307.1 The partial filling of a prescription for a controlled substance listed in Schedule II is permissable, if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription…

1308 LABELING OF SUBSTANCES LISTED IN SCHEDULE II 1308.1 The pharmacist filling a written or emergency oral prescription for a controlled substance listed in Schedule II shall affix to the package a label meeting the requirements set forth in § 1912.2 of this title. 1308.2 The la…

1309 PRESCRIPTIONS FOR CONTROLLED SUBSTANCES LISTED IN SCHEDULES III, IV AND V 1309.1 Unless otherwise permitted under federal law, a pharmacist shall dispense directly a controlled substance listed in Schedule III, IV or V, which is a prescription drug as determined under the Fe…

1310 REFILLING OF PRESCRIPTIONS LISTED IN SCHEDULES III, IV OR V 1310.1 A prescription for a controlled substance listed in Schedule III, IV, or V may not be filled or refilled more than six (6) months after the date on which the prescription was issued. 1310.2 A prescription aut…

1311 PARTIAL FILLING OF PRESCRIPTIONS LISTED IN SCHEDULES III, IV OR V 1311.1 The partial filling of a prescription for a controlled substance listed in Schedules III, IV or V is permissible within six (6) months after date thereof provided that the following occurs: (a) The tota…

1312 LABELING OF SUBSTANCES LISTED IN SCHEDULES III, IV OR V 1312.1 The pharmacist filling a prescription for a controlled dangerous substance listed in Schedule III, IV or V shall affix to the package a label meeting the requirements set forth in § 1912.2 of this title. 1312.2 T…