District of Columbia Administrative Code

1908 SANITATION STANDARDS 1908.1 The sanitary standards contained in this section shall apply to all pharmacies and drug and medical device storage areas, unless otherwise exempted by this chapter or the Director. 1908.2 A pharmacy and all areas under the control of the pharmacy,…

1909 REQUIRED EQUIPMENT AND REFERENCES 1909.1 The equipment and references requirements of this section shall apply to all pharmacies, unless otherwise exempted by this chapter or the Director. 1909.2 The pharmacist-in-charge shall be responsible for maintaining the following: (a…

1910 SECURITY AND SAFEGUARDS AGAINST DRUG DIVERSION 1910.1 The security and safeguards requirements of this section shall apply to all pharmacies, unless otherwise exempted by this chapter or the Director. 1910.2 A pharmacy shall have a security alarm system which: (a) Detects un…

1911 PACKAGING AND HANDLING OF DRUGS AND MEDICAL DEVICES 1911.1 The packaging and handling requirements of this section shall apply to all pharmacies, unless otherwise exempted by this chapter or the Director. 1911.2 A pharmacy shall dispense drugs or medical devices in new and c…

1912 LABELING OF DISPENSED DRUGS 1912.1 The labeling requirements of this section shall apply to all pharmacies, unless otherwise exempted by this chapter or the Director. 1912.2 A container in which a prescription drug or device is sold or dispensed must bear a label containing …

1913 RECORDKEEPING 1913.1 The recordkeeping requirements of this section shall apply to all pharmacies, unless otherwise exempted by this chapter or the Director. 1913.2 A pharmacy shall maintain on a current basis a complete and accurate record of all prescription drugs and devi…

1914 COMPUTERIZED RECORDKEEPING 1914.1 A pharmacy may use an automated data processing system to meet the recordkeeping requirements under § 1913 of this Title if the system meets the requirements of this section. 1914.2 The automated data processing system shall have: (a) Adequa…

1915 AUTOMATED MEDICATION DISPENSING SYSTEMS 1915.1 An automated medication dispensing system may be utilized in a licensed pharmacy or health care facility if the requirements of this section are being met. 1915.2 An automated medication dispensing system shall be used only in s…

1916 REMOTE AUTOMATED PHARMACY SERVICES 1916.1 The purpose of this section is to provide standards for the provision of remote pharmacy services by a provider pharmacy in a facility that is not at the same location as the provider pharmacy through an automated pharmacy system. 19…

1917 TELEPHARMACY SERVICES 1917.1 The purpose of this section is to provide standards for the provision of remote pharmacy services by a provider pharmacy in a facility that is not at the same location as the provider pharmacy through a telepharmacy system. 1917.2 Telepharmacy sy…

1918 PROSPECTIVE DRUG REGIMEN REVIEW 1918.1 For purposes of promoting therapeutic appropriateness, a pharmacist shall, prior to or at the time of dispensing a prescription drug order, review the patient's medication record and each prescription drug order presented for dispensing…

1919 PATIENT COUNSELING 1919.1 Following review of a patient's medical record and prior to dispensing a drug or medical device, a pharmacist shall make a verbal offer to counsel, or his designee shall notify the patient or the patient's agent of the opportunity to receive an oral…

1920 PHARMACIST-IN-CHARGE 1920.1 A retail/community pharmacy, special or limited use pharmacy, or non-resident pharmacy shall be managed by a pharmacist (hereafter referred to as "Pharmacist-in-charge"). The pharmacist-in-charge shall be licensed to practice pharmacy in the Distr…

1921 INSTITUTIONAL PHARMACIES 1921.1 An institutional pharmacy shall be managed by a pharmacist (hereafter referred to as "Director of Pharmacy ") who is licensed to practice pharmacy in the District of Columbia. 1921.2 The Director of Pharmacy shall be a full-time employee of th…

1922 NUCLEAR PHARMACIES 1922.1 A pharmacy, institution, or other establishment that provides radiopharmaceutical services shall obtain from the Director a nuclear pharmacy license. The license to operate a nuclear pharmacy shall be conditioned upon approval of the United States N…

1923 PHARMACY FEES 1923.1 The fees related to pharmacies are as follows: (a) Biennial License Fee: $900.00 (b) Late Fee: $125.00 (c) Non-Resident Pharmacy Registration Fee: $900.00 (d) Duplicate certificate: $35.00 (e) License validation: $35.00 SOURCE: Final Rulemaking published…

1925 INSPECTION AND INVESTIGATION 1925.1 The Director, or his agent, shall have the right to enter upon and into the premises of any licensee, registrant, applicant for a license or registration, pharmacy or other location where prescription drugs or devices are stored, or reason…

1926 TAKING OF SAMPLES 1926.1 Whenever the Director or other authorized agent of the Department has reason to believe that a drug or medical device is maintained or dispensed in violation of these rules or other District or federal laws or regulations, he or she may take a sample…

1927 OPPORTUNITY FOR A HEARING 1927.1 The Director shall take action to deny, suspend, or revoke a pharmacy license pursuant to § 11 of the Act, D.C. Code, 2001 Ed. § 47-2885.10. 1927.2 Except for a summary suspension undertaken pursuant to § 11(b) of the Act, D.C. Code, 2001 Ed.…

1928 NOTICE OF CONTEMPLATED ACTION 1928.1 When the Director contemplates denying a license for failure to qualify, he or she shall give the applicant written notice containing the following statements: (a) That the applicant has failed to satisfy the Director as to the applicant’…

1929 NOTICE OF HEARING 1929.1 Any notice required by this chapter may be served either personally or by certified mail, return receipt requested, directed to the respondent at his or her last known address as shown by the records of the Department of Consumer and Regulatory Affai…

1930 PROCEDURE WHEN A RESPONDENT FAILS TO RESPOND TO A HEARING NOTICE 1930.1 If the respondent does not respond to the hearing notice within the time specified, the Director may, without a hearing, take the action contemplated in the notice. The Director shall, in writing, inform…

1931 HEARINGS-SUMMARY SUSPENSION AND DENIAL OF RENEWAL 1931.1 A hearing shall be convened within five (5) days of the institution of proceedings in the following cases: (a) Summary suspension; and (b) Denial of renewal. 1931.2 A respondent who has been summarily suspended pursuan…

1932 CONDUCT OF HEARINGS 1932.1 All hearings before the Director shall be open to the public. 1932.2 The Director, or his or her designee, shall hear the evidence and render a decision. 1932.3 A respondent entitled to a hearing shall have the following rights: (a) To be represent…

1933 DECISIONS 1933.1 The decision of the Director shall include the following: (a) Findings of fact; (b) Conclusions of law; and (c) A statement informing the respondent concerning his or her right to have the decision reviewed by the Board of Appeals and Review, and the time pe…

1934 ADMINISTRATIVE AND JUDICIAL REVIEW 1934.1 When a respondent fails, for good cause, to appear for a hearing which has been scheduled, the respondent may, within thirty (30) days from the date of the decision, apply to the Director to reopen the proceedings. The Director, upon…

1999 DEFINITIONS 1999.1 When used in this chapter, the following words and phrases shall have the meanings ascribed: Act - the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, D.C. Code, 2001 Ed. §§ 47-2885.01 to 47-2885.23, as amended. Administer - the direct…

200 GENERAL PROVISIONS 200.1 The purpose of this chapter is to prevent and control the spread of communicable diseases. 200.2 This chapter shall be applicable to all cases or suspected cases, contacts, or carriers of the communicable diseases denominated in this chapter insofar a…

201 COMMUNICABLE DISEASE SURVEILLANCE 201.1 The following diseases shall be considered communicable diseases for the purpose of communicable disease surveillance and shall be reported by telephone to the Director immediately upon provisional diagnosis or the appearance of suspici…

202 REPORTING OCCURRENCES 202.1 The physician, veterinarian, or other person in charge of a communicable disease case shall report the case to the Director within the period of time required and in the manner prescribed in § 201. 202.2 In the report required in § 202.1, the physi…

203 RABIES AND ANIMAL BITES 203.1 A veterinarian or other person who has reason to suspect any of the following shall report that fact immediately by telephone to the Director, and shall immediately follow the telephone report with a written report to the Director: (a) A dog or o…

205 TESTS FOR SYPHILIS AND GONORRHEA REQUIRED DURING PREGNANCY 205.1 Unless the person in charge of a case of pregnancy includes in the patient's case history a written statement giving the medical reasons why a serological test for syphilis and a laboratory test for gonorrhea pe…

206 HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION 206.1 All Human Immunodeficiency Virus (HIV) infection cases and pregnancies in HIV-infected women (including Acquired Immune Deficiency Syndrome (AIDS)) shall be reported to the Director of the Department of Health or his or her d…

207 HEPATITIS B TESTING AND VACCINATION 207.1 A provider that attends to, treats, or examines a pregnant woman or provides perinatal treatment shall: (a) Take a blood sample during the first prenatal visit and submit the sample to a laboratory approved by the Department for testi…

208 HEALTH CARE ASSOCIATED INFECTIONS 208.1 Acute care, ambulatory, long-term acute care, skilled nursing, and outpatient renal dialysis facilities shall permit the Director access through the National Healthcare Safety Network (NHSN) to data on health care-associated infections …

209 COMMUNICABLE DISEASES CONTRACTED BY STUDENTS, SCHOOL EMPLOYEES, CONTRACTORS, INTERNS, AND VOLUNTEERS 209.1 Each school shall encourage its students to adhere to the following preventive measures designed to minimize the transmission of communicable diseases: (a) Use tissues f…

210 INVESTIGATIONS AND ENFORCEMENT 210.1 Upon receiving a report of the existence of a case or suspected case of a communicable disease, or of a communicable disease contact or carrier, the Director shall make any investigation that he or she deems necessary for the purpose of de…

211 LABORATORIES AND BLOOD BANKS 211.1 Physicians and others licensed under the District of Columbia Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 to 3-1213.01 (2001 ed.)), to practice in the District may submit …

212 CLEANSING OF PREMISES 212.1 Upon release from isolation, removal to a hospital, or any other change of location of any person affected with diphtheria, smallpox, tuberculosis, or any salmonella infection, the room or rooms which have been occupied by the person shall be clean…

213 PERSONS AFFECTED BY COMMUNICABLE DISEASES 213.1 No person who is affected by, or believed by the Director upon probable cause to be affected by, a communicable disease in a communicable form; and no person who is, or is believed by the Director upon probable cause to be, a ca…

214 DEATHS OF AFFECTED PERSONS 214.1 In cases of death from cholera, anthrax, diphtheria plague (bubonic and pneumonic), smallpox, or louse-borne typhus fever, the physician issuing the certificate of death shall give immediate notice by telephone of the death to the Director. 21…

215 MONITORING AND REPORTING THE OCCURRENCE OF CANCER 215.1 Each health care provider and health care facility shall report benign tumors of the brain and central nervous system and all malignant cancers as follows: (a) Each health care provider and health care facility shall rep…

216 QUALITY ASSURANCE/ACCESS TO RECORDS 216.1 A District of Columbia Central Cancer Registrar or other person designated by the Director is authorized to visit any health care facility or health care provider to review and duplicate reports required by this chapter or records tha…

217 CONFIDENTIALITY 217.1 The Department shall use information from reports submitted pursuant to these rules for statistical and public health purposes only. 217.2 No person shall disclose or re-disclose identifying information included in a cancer report submitted pursuant to t…

218 PENALTIES 218.1 Any person who willfully does not comply with the reporting requirements set forth in § 215 or the access to records required in § 216 shall be guilty of a misdemeanor, and upon conviction, subject to a fine not to exceed one thousand dollars ($ 1,000). 218.2 …

219 MATERNAL MORTALITY REPORTING 219.1 Each health care facility shall report to the Department all maternal mortalities, as defined in § 299.1. 219.2 All health care facilities shall report all maternal mortalities required by § 219.1 in writing within five (5) days after death …

220 SEVERE MATERNAL MORBIDITY 220.1 Each health care facility shall report to the Department each severe maternal morbidity, as defined in § 299. 220.2 Each health care facility shall report each severe maternal morbidity in writing within five (5) days of the end of each event c…

221 CLINICAL LABORATORY GENOMIC SEQUENCING OF SARS-CoV-2 221.1 A clinical laboratory operating in the District of Columbia, a clinical laboratory providing services to a health care facility located in the District of Columbia, or a clinical laboratory providing services to a hea…