District of Columbia Administrative Code

403 CONDITIONAL LICENSE 403.1 The Director may issue a license with specific conditions that are stated on the license. 403.2 The expiration license date, if any, of each condition shall be specified on the license. 403.3 The Director may revoke the license, if the Director deter…

404 APPLICATION FOR OUT-OF-STATE REGISTRATION 404.1 An out-of-state drug manufacturer, distributor, or wholesaler who conducts distribution activities within the District of Columbia shall be required to register with the Director. 404.2 No person required to be registered shall …

405 RENEWAL OF REGISTRATION FOR OUT-OF-STATE DRUG MANUFACTURERS, DISTRIBUTORS, REPACKAGERS, AND WHOLESALERS 405.1 The Director shall mail a renewal notice to an out-of-state registrant by first class mail to the registrant’s last known address on file with the Director at least f…

406 EXEMPTIONS 406.1 The following shall be exempt from licensure and registration: (a) Manufacturers’ representatives that distribute drug samples; (b) Distributors’ representatives that distribute drug samples; (c) Group purchasing organizations established to maintain and to o…

407 PERSONNEL 407.1 A pharmacist licensed in the District of Columbia or an individual approved by the Director 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 …

408 SECURITY 408.1 All facilities used for manufacturing and wholesale drug distribution shall be secure from unauthorized entry as follows: (a) Access from outside the premises shall be kept to a minimum and be well controlled; (b) The outside perimeter of the premises shall be …

409 WRITTEN POLICIES AND PROCEDURES 409.1 Licensees shall establish, maintain, and adhere to written policies and procedures for the receipt, security, storage, inventory and distribution of drugs. Written policies shall include the following: (a) Procedures for identifying, reco…

410 SALVAGING AND REPROCESSING 410.1 All facilities licensed pursuant to this chapter shall be in compliance with applicable provisions of Federal, state or local laws or regulations relating to drug product salvaging or reprocessing. SOURCE: Final Rulemaking published at 39 DCR …

411 EXAMINATION OF MATERIALS 411.1 Manufacturers, distributors and wholesalers upon receipt of each incoming shipping container shall carefully inspect all shipments of drugs to determine their identity and to prevent the acceptance of contaminated drugs unfit for distribution. T…

412 LABELING, HANDLING, STORAGE, AND RECORDKEEPING STANDARDS 412.1 Drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other drugs until they are destroyed or returned to their supplier. 412.2 Any drug whos…

413 INSPECTIONS 413.1 The Director shall conduct an on-site inspection of an applicant’s facility before a license is granted. 413.2 Applicants and licensees shall permit the Director or any authorized District official to enter and inspect their premises and delivery vehicles, a…

414 SUSPENSION, DENIAL, REVOCATION OF LICENSE 414.1 The Director shall take action to deny, suspend, or revoke a license, or convert the license to a conditional license, subject to the right of a hearing as provided by this chapter. 414.2 Grounds for suspension, revocation, deni…

415 WITHDRAWAL OF REGISTRATION 415.1 The Director may withdraw registration of a registrant who is not licensed or registered in the state in which they are physically located, or in good standing under Federal law or the laws of the state in which incorporated. 415.2 The Directo…

416 OPPORTUNITY FOR A HEARING 416.1 The Director shall take action to deny, suspend, or revoke a license, or convert the license to a conditional license pursuant to § 11 of the Act, D.C. Code, 2001 Ed. § 48-710. 416.2 Except for summary suspension undertaken pursuant to § 10 of …

417 NOTICE OF PROPOSED ACTION 417.1 When the Director proposes to deny a license for failure to meet the requirements of the Act or this chapter, the applicant shall be given written notice containing the following statements: (a) That the applicant has failed to satisfy the Dire…

418 NOTICE OF HEARING 418.1 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 filed with the Director by the respondent. 418.2 If …

419 PROCEDURE WHEN A RESPONDENT FAILS TO RESPOND TO A HEARING NOTICE 419.1 If the respondent does not respond to the hearing notice within the time specified, the Director may, without a hearing, take the action proposed in the notice. The Director shall, in writing, inform the r…

420 HEARINGS: SUMMARY SUSPENSION 420.1 A respondent who has been summarily suspended pursuant to § 10 of the Act, D.C. Code, 2001 Ed. § 48-709, shall be notified in writing of the action being taken and that the licensee is entitled to a hearing, upon written request within three…

421 HEARINGS: CEASE AND DESIST ORDERS 421.1 The Director may issue a cease and desist order when a hazardous condition exists that may endanger the health, safety, or welfare of the community. 421.2 The violator shall be notified in writing to cease operations immediately and tha…

422 EMBARGO 422.1 If the Director determines that a drug is adulterated or misbranded, the Director may order that the drug be removed from availability for distribution, sale, consumption, or use, or that the drug be destroyed or embargoed. 422.2 A person subject to an embargo s…

423 CONDUCT OF HEARINGS 423.1 All hearings before the Director shall be open to the public. 423.2 The Director, or his or her designee, shall hear the evidence and render a decision. 423.3 A respondent entitled to a hearing shall have the following rights: (a) To be represented b…

424 DECISIONS 424.1 The decision of the Director shall include the following: (a) Findings of fact; (b) Conclusions of law; and (c) A statement informing the respondent of the right to have the decision reviewed by the Board of Appeals and Review, and the time period within which…

425 ADMINISTRATIVE AND JUDICIAL REVIEW 425.1 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 f…

499 DEFINITIONS 499.1 When used in this chapter, the following words or phrases shall have the meanings ascribed: Act - the District of Columbia Drug Manufacture and Distribution Licensure Act of 1990, D.C. Code, 2001 Ed. § 48-701 to 48-715. Conditional License - a license issued…

4000 GENERAL PROVISIONS 4000.1 The provisions of Chapters 40 through 45 shall apply to a review of an application for a Certificate of Need (CON) required under Section 7 of the District of Columbia Health Services Planning Program Re-Establishment Act of 1996 as amended (Act), e…

4001 STATE HEALTH PLANNING AND DEVELOPMENT AGENCY AND STATEWIDE HEALTH COORDINATING COUNCIL 4001.1 The project application and review files of SHPDA shall be open for public inspection and review during regular business hours. 4001.2 SHPDA shall duplicate CON documents for any pe…

4002 PRE-APPLICATION CONSULTATION WITH PROSPECTIVE APPLICANT 4002.1 A prospective applicant for a CON may consult with a designated member of SHPDA staff before submitting a Letter of Intent for any project and during the application process. 4002.2 The Director shall assign a st…

4003 LETTER OF INTENT AND PUBLIC NOTICE 4003.1 Before submitting a formal application for a CON, an applicant shall submit a Letter of Intent to the Director for the purposes of notifying SHPDA that an application for a CON will be forthcoming and providing SHPDA sufficient time …

4004 CONDITIONAL CERTIFICATES OF NEED 4004.1 SHPDA may require an applicant to comply with certain conditions when granting a CON, provided that the conditions relate directly to an adopted SHPDA review criteria. 4004.2 The expiration date, if any, of each condition shall be spec…

4005 PROPOSED CHANGES IN APPROVED PROJECTS 4005.1 The Director shall specify in the CON the maximum amount of capital expenditure that may be obligated under the CON. 4005.2 A CON holder shall report a proposed change in the project budget that will result in an expenditure great…

4006 PRE-OPERATIONAL INSPECTION 4006.1 A CON holder shall not begin operation of an approved project until SHPDA has conducted a preoperational inspection and has determined that the project is in compliance with the CON requirements. 4006.2 For a large project that may be comple…

4007 ISSUANCE AND EXTENSION OF CERTIFICATE OF NEED 4007.1 A CON shall be issued for a period of up to three (3) years as the Director determines to be appropriate. An applicant may request, and the Director may grant, an applicant’s written request for a CON period of less than t…

4008 PROGRESS REPORTS 4008.1 A CON holder shall make quarterly progress reports to SHPDA. 4008.2 A progress report shall include the following information, if applicable: (a) Original CON registration number; (b) Status of the project, including current estimated completion date,…

4009 SALE OR TRANSFER OF EFFECTIVE CONTROL 4009.1 Pursuant to D.C. Official Code § 44-411 a CON may not be sold or transferred. The sale or transfer of effective control over a project for which a current CON has been granted shall cause the CON to be subject to review and approv…

4010 ENFORCEMENT AND REMEDIES FOR NONCOMPLIANCE 4010.1 The Director may request that the Office of the Attorney General enjoin the activities of a person offering, developing, or operating a health care facility in violation of the Act, as specified in D.C. Official Code § 44-416…

4011 NOTICE OF CERTAIN CAPITAL EXPENDITURES 4011.1 A health care facility or service (except an HMO exempt under D.C. Official Code § 44-407(c) and 22 DCMR 4109) shall notify SHPDA that it intends to obligate an expenditure of two million five hundred thousand dollars ($ 2,500,00…

4012 GENERAL CRITERIA AND STANDARDS FOR REVIEW 4012.1 Whenever a criterion or standard requires proof of a fact, the applicant shall have the burden of affirmatively proving that fact. 4012.2 The criteria and standards set forth in this section shall apply to every CON applicatio…

4013 FEES 4013.1 Pursuant to D.C. Official Code § 44-420(a), SHPDA shall collect application fees for a CON request. SHPDA may collect fees for data, analyses, and reports published by SHPDA. SHPDA shall also collect an annual user fee for private hospitals in lieu of a CON appli…

4015 [REPEALED] SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations…

4020 [REPEALED] SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations…