District of Columbia Administrative Code

1313 FILING OF PRESCRIPTION ORDERS 1313.1 Prescription orders for controlled substances in Schedules I and II shall be maintained in a file separate from all other records of the pharmacy. 1313.2 Prescription orders for controlled substances in Schedules III, IV and V shall be ma…

1314 DISPENSING WITHOUT A PRESCRIPTION 1314.1 A controlled substance listed in Schedule II, III, IV or V which is not a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, may be dispensed by a pharmacist without a prescription to a purchaser at retail…

1315 DELIVERY OF PRESCRIPTION MEDICATION BY MAIL OR CARRIER 1315.1 This section shall apply to a pharmacy's delivery of filled prescriptions for individual patients by United States Postal Service, common carrier, employee or courier service to an address within the District of C…

1316 TRANSFER BETWEEN PHARMACIES OF PRESCRIPTION INFORMATION FOR REFILL PURPOSES 1316.1 The transfer of original prescription information for a controlled substance listed in Schedules III, IV, or V for the purpose of refill dispensing is permissible, subject to the requirements …

1317 ADMINISTERING OR DISPENSING OF CONTROLLED SUBSTANCES 1317.1 The administering or dispensing directly (but not prescribing) of controlled substances listed in any schedule to a controlled substance dependent person for the purpose of detoxification or for continuing his or he…

1318 [RESERVED] SOURCE: Final Rulemaking published at 53 DCR 10055 (December 22, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1318 AUTHORITY: DC-DCMR Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of…

1319 [RESERVED] SOURCE: Final Rulemaking published at 53 DCR 10055 (December 22, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1319 AUTHORITY: DC-DCMR Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of…

1320 DISTRIBUTION BY A DISPENSER TO ANOTHER PRACTITIONER OR A REVERSE DISTRIBUTOR 1320.1 A practitioner who is authorized to dispense a controlled substance may distribute (without being registered to distribute) a quantity of the substance to: (a) A reverse distributor who is re…

1321 DISTRIBUTION TO SUPPLIER 1321.1 A person lawfully in possession of a controlled substance listed in any schedule may distribute (without being registered to distribute) that substance, to the person from whom he or she obtained it or to the manufacturer of the substance, or,…

1322 DISTRIBUTION UPON DISCONTINUANCE OR TRANSFER OF BUSINESS 1322.1 A registrant desiring to discontinue business activities altogether or with respect to controlled substances (without transferring such business activities to another person) shall: Return for cancellation his o…

1323 MANUFACTURE AND DISTRIBUTION OF CONTROLLED SUBSTANCE SOLUTIONS AND COMPOUNDS BY A PHARMACIST 1323.1 A pharmacist may manufacture (without being registered to manufacture) an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in a p…

1324 PROCEDURE FOR DISPOSING OF LEGALLY OBTAINED CONTROLLED SUBSTANCES 1324.1 Any registrant in possession of legally obtained controlled substances and desiring or required to dispose of any of these substances shall contact Drug Enforcement Administration, Regional Office, for …

1325 ISSUANCE OF NON-CONTROLLED SUBSTANCES 1325.1 A pharmacist shall dispense a non-controlled substance, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, or medical device pursuant to a valid written, oral, facsimile, or electronic presc…

1326 GENERIC SUBSTITUTION 1326.1 A pharmacist may dispense a generically equivalent drug product if: The generic product costs the patient less than the prescribed drug product; The patient does not refuse the substitution; and The prescribing practitioner does not indicate on th…

1327 SUBSTITUTION OF DOSAGE FORMS 1327.1 A pharmacist may dispense a dosage form of a drug product different from that prescribed, such as a tablet instead of a capsule or liquid instead of tablets, provided that: The pharmacist notifies the patient of the dosage form substitutio…

1328 THERAPEUTIC INTERCHANGE 1328.1 This section shall not apply to generic drug substitutions. For generic drug substitutions, see the requirements of § 1326 of this chapter. As used in this section, “therapeutic interchange” means the dispensing of chemically different drugs th…

1329 RETURN OF PRESCRIPTION DRUGS 1329.1 In the interest of the public health of the District of Columbia and the possible adverse effects which the resale of drugs may have upon the health of the public, it shall be unlawful for any licensed pharmacist to accept any unused presc…

1330 [REPEALED] SOURCE: Final Rulemaking published at 36 DCR 8154 (December 1, 1989); as amended by Final Rulemaking published at 53 DCR 10055 (December 22, 2006); as amended by Final Rulemaking published at 56 DCR 4742 (June 19, 2009). District of Columbia Municipal Regulations …

1331 [REPEALED] SOURCE: Final Rulemaking published at 42 DCR 5016 (September 1, 1995); as amended by Final Rulemaking published at 56 DCR 4742 (June 19, 2009). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1331 AUTHORITY: DC-DCMR Section 19(a)(…

1332 DRUG MANUFACTURERS AND DISTRIBUTORS FEES 1332.1 The licensure fees for drug manufacturers and distributors located within the District of Columbia are as follows: (a) Annual fee $200.00* (b) Late fee 100.00 (c) Duplicate certificate 20.00 (d) License validation 20.00 1332.2 …

1333 PRESCRIPTION REQUIREMENTS FOR MEDICAID COVERED SERVICES 1333.1 Effective April 1, 2008, a written prescription for any drug, including over-the-counter drugs, for a Medicaid fee for service beneficiary shall only be written on tamper resistant prescription pads meeting at le…

1399 DEFINITIONS 1399.1 As used in this chapter, the following words and phrases shall have the meanings ascribed: Act - District of Columbia Uniform Controlled Substances Act of 1981, effective August 5, 1981 (D.C. Law 4-29; D.C. Official Code § 48-901.01). Administer - the dire…

1500 AUTHORITY TO MAKE INSPECTIONS 1500.1 In carrying out its functions under the Act, the Chief Pharmaceutical Control Officer and his or her designee, is authorized in accordance with §§302(f) and 505 of the Act to enter controlled premises and conduct administrative and non-ad…

1501 INSPECTIONS 1501.1 An inspection shall be carried out by an inspector from the Department's Service Facility Regulation Administration, Pharmaceutical and Medical Devices Control Division or other employee authorized by the Act or the Director. 1501.2 The inspector prior to …

1502 RECORDS AND REPORTS 1502.1 Every registrant shall keep records, maintain inventories and file reports in conformance with the requirements of federal law including the requirements prescribed under 21 C.F.R. Part 1304. SOURCE: Final Rulemaking published at 33 DCR 1046, 1080 …

1503 ACCOUNTABILITY AUDITS 1503.1 Accountability audits in pharmacies shall be accomplished through a review of invoices, prescription file, other records required by federal and District of Columbia laws and regulations, and this chapter. 1503.2 Accountability audits of medical,…

1504 ORDER FORMS 1504.1 Controlled Substances in Schedule I or II shall be distributed by a registrant to another registrant only pursuant to an order form. Compliance with the provisions of federal law and regulations respecting order forms shall be deemed compliance with this c…

1505 RETENTION OF RECORDS 1505.1 All records required by this chapter shall be retained for a period of at least two (2) years. SOURCE: Final Rulemaking published at 33 DCR 1046, 1081 (February 21, 1986). AUTHORITY: DC-DCMR Unless otherwise noted, the authority for this chapter i…

1599 DEFINITIONS 1599.1 The provisions of §1099 of Chapter 10 of this subtitle and the definitions set forth in that section shall apply to this chapter. SOURCE: Final Rulemaking published at 33 DCR 1046, 1081 (February 21, 1986). AUTHORITY: DC-DCMR Unless otherwise noted, the au…

1600 GENERAL PROVISIONS 1600.1 Respite care shall provide support services to mentally retarded persons in order to give a primary caregiver temporary overnight relief from the daily responsibilities of caring for each mentally retarded individual who lives in his or her home. 16…

1601 APPLICATION PROCESS 1601.1 Respite care shall be requested at least thirty (30) days in advance of any anticipated need for respite care services. 1601.2 A primary caregiver of a mentally retarded person who is a citizen of the District of Columbia may make application for r…

1602 NOTIFICATION TO APPLICANT 1602.1 The Administration shall give each applicant oral and written notice of its determination under § 1601.3, within fifteen (15) days of receipt of the completed application, including any additional information requested. 1602.2 If the applican…

1603 PLACEMENT PROCESS 1603.1 The Administration shall make referrals to appropriate facilities in order to identify a facility that will accept the mentally retarded person who is in need of respite care services. 1603.2 Prior to the placement of the mentally retarded person int…

1604 EMERGENCY RESPITE 1604.1 When the primary caregiver believes that an emergency exists which jeopardizes the residential placement temporarily, they may request emergency respite care. 1604.2 The Administration shall assess each request for emergency respite and make a determ…

1699 DEFINITIONS 1699.1 For the purpose of this chapter, the following definitions shall apply unless otherwise provided: Applicant - a parent, guardian or family member for the mentally retarded person. Community Residence Facility - a facility that provides a sheltered living e…

1800 MANNER OF REPORTING AND FILING FEE 1800.1 Beginning July 1, 2007, each manufacturer or labeler of prescription drugs, directly or indirectly distributed for dispensation in the District, that employs, directs or utilizes marketing representatives in the District shall file t…

1801 CONTENT OF ANNUAL REPORT 1801.1 The annual report shall include the following information as it pertains to prescription drug marketing costs and activities expended by the manufacturer or labeler in the District in a form that provides the value, nature, purpose, and recipi…

1802 SUBMISSION OF ANNUAL REPORT 1802.1 Each manufacturer or labeler subject to reporting under the Act, shall submit the required annual report to the Department in an electronic format that is satisfactory to the Director. 1802.2 For each gift which was provided during the repo…

1803 CONFIDENTIALITY AND PUBLIC INFORMATION 1803.1 Notwithstanding any provision of law to the contrary, information submitted to the Department pursuant to this title shall be confidential and not a public record. 1803.2 A manufacturer or labeler subject to reporting under the A…

1804 ENFORCEMENT AND FINE 1804.1 These rules may be enforced in a civil action brought by the Office of the Attorney General for the District of Columbia. 1804.2 Failure to timely file a complete annual report in accordance with the Act and the provisions of this chapter constitu…

1805 DEPARTMENT REPORTS 1805.1 Beginning November 30, 2007, the Department shall provide an annual report, providing information in aggregate form, on prescription drug marketing expenses, to the Council and the Attorney General by November 30th of each year. 1805.2 Beginning Jan…

1899 DEFINITIONS 1899.1 As used in this Chapter the following terms shall have the meanings ascribed: Act - AccessRx Act of 2004, effective May 18, 2004 (D.C. Law 15-164; D.C. Official Code § 48-831.01 et seq.) Affiliate - any individuals, partnerships, corporations, joint ventur…

1900 GENERAL PROVISIONS 1900.1 It shall be unlawful for any person to operate, maintain, open, or establish a pharmacy within the District of Columbia without a valid license or registration from the Mayor. 1900.2 It shall be unlawful for an establishment or institution, or any p…

1901 GENERAL OPERATING STANDARDS 1901.1 A pharmacy shall be operated only by pharmacist holding a valid license in the District of Columbia to practice pharmacy or, if a non-resident pharmacy, a valid license in the state in which the pharmacy is physically located. 1901.2 A lice…

1902 NEW LICENSURE OF PHARMACIES 1902.1 Licenses shall be issued for the following categories of pharmacies as defined in this chapter, except for non-resident pharmacies, which shall be required to register with the Department: (a) Retail pharmacy/community pharmacy; (b) Nuclear…

1903 REGISTRATION OF NONRESIDENT PHARMACIES 1903.1 The purpose of these rules is to provide standards for the operation of nonresident pharmacies, which dispense or distribute prescription drugs or medical devices, directly or indirectly such as through the use of an agent or int…

1904 RENEWAL OF PHARMACY LICENSE 1904.1 The Director shall mail a renewal notice to a licensee by first class mail to the licensee's last known address on file with the Director at least sixty (60) days prior to the expiration of the license. 1904.2 The failure of a licensee to r…

1905 CHANGE IN PHARMACY NAME, PROPRIETORSHIP, OR LOCATION 1905.1 A proprietor desiring to change the name of a pharmacy shall apply to the Director on a form prescribed by the Director and pay the required fee. 1905.2 A proprietor desiring to change the location of a pharmacy wit…

1906 CLOSING A PHARMACY 1906.1 Whenever a pharmacy plans to discontinue operation, the proprietor shall, in addition to the requirements of this section, comply with the provisions of § 1323 of this Title, and notify the Director of the closing of the pharmacy not later than fift…

1907 PHYSICAL STANDARDS 1907.1 The physical standards contained in this section shall apply to all pharmacies, unless otherwise exempted by this chapter or the Director. 1907.2 A pharmacy shall meet the applicable requirements of the District of Columbia zoning, building, fire, p…