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D.C. Municipal Regulations (Last Updated: September 13, 2017) |
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Title 22. HEALTH |
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SubTilte 22-B. PUBLIC HEALTH AND MEDICINE |
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Chapter 22-B19. PHARMACIES |
Section 22-B1999. DEFINITIONS
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1999.1When 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 application of a drug to the body of a patient or research subject by injection, inhalation, ingestion, or any other means.
Adulterated drug or device - the meaning as defined in § 501 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 351, as amended.
Adulterated drug or medical device - as defined in § 501 of the Federal Food, Drug and Cosmetic Act, (Pub. L. 96-354, 21 USC § 351) as amended.
Applicant - a person, partnership, or corporation applying for a license to practice pharmacy under this chapter.
Automated data processing system - a system utilizing computer software and hardware for the purpose of recordkeeping.
Automated medication dispensing system - a robotic, computerized, or mechanical device and its components that distributes or dispenses medications in a licensed health care facility, or prepares medications for final dispensing by a licensed pharmacist to a patient or a patient's agent, and maintains related transaction information.
Board - The District of Columbia Board of Pharmacy established by the District of Columbia Health Occupations Revision of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code § 3-1201.01 et seq.)
Centralized automated medication system - an automated medication system located in a pharmacy from which medication is distributed or prepared for final dispensing by a licensed pharmacist for a specific patient.
Community/Retail pharmacy - a pharmacy as defined under HORA that provides pharmacy services to the public or general community on an outpatient basis, whether at retail, through third party payment, or other measure of no or minimum cost to the consumer.
Compounding - the preparation, mixing, assembling, packaging, or labeling of a drug or device as the result of a practitioner's prescription drug order or for the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing. Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.
Computer - programmable electronic device capable of multi-functions, including, but not limited to, storage, retrieval, and processing information.
Controlled substances - those drug items or chemicals regulated under the Federal Controlled Substances Act of 1970, approved October 27, 1970 (Pub.L. 91-513, 21 USC § 801 et seq.) as amended; and the District of Columbia Uniform Controlled Substances Act of 1981, effective August 5, 1981 (D.C. Law 4-29, D.C. Official Code § 48-901 et seq.) as amended.
CRT - cathode ray tube used to impose visual information on a screen.
Decentralized automated medication system - an automated medication system that is located outside of the pharmacy in a health care facility with an on-site pharmacy and in which medication is stored in a manner that may be, but need not be, patient specific.
Department - The District of Columbia Department of Health.
Director - The Director of the District of Columbia Department of Health.
Director of Pharmacy - the licensed pharmacist in an institutional facility who is in direct charge of, and has overall responsibility for the operation and management of pharmacy services of that institution.
Dispense - the interpretation, evaluation, and implementation of a prescription drug order, including the preparation and delivery of a drug or medical device to a patient or patient's agent.
Distribute - the actual, constructive, or attempted transfer from one person to another, other than by administering or dispensing, of a drug or medical device whether or not there is an agency relationship.
Downtime - that period of time when a computer is inoperable.
Drug - means:
(a)any substance recognized as a drug, medicine, or medicinal chemical in the official United States Pharmacopoeia, official National Formulary, official Homeopathic Pharmacopoeia, or official Veterinary Medicine Compendium or other official drug compendium or any supplement to any of them;
(b)any substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animal;
(c)any chemical substance (other than food) intended to affect the structure or any function of the body of man or other animal; and
(d)any substance intended for use as a component of any items specified in subparagraph (a), (b), or (c) of this paragraph, but does not include medical devices or their components, parts, or accessories.
Expired drug or medical device - expiration of the date required by the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 352, to be placed on the label of the original container by the manufacturer, packer, or distributor for which the product may be placed on the market for use or consumption.
Final Verification - The review of the final prescription prior to delivery to a patient to ensure that the ordered medication or medical device is properly prepared and placed in a suitable container with appropriate labeling
Hardware - the fixed component parts of a computer.
HIPAA - The Federal Health Insurance Portability and Accountability Act of 1996, approved August 21, 1996 (42 U.S.C. §§ 1320d-1320d-8).
Homeopathic Drug - A substance that has known "homeopathic provings" and/or known effects which mimic the symptoms, syndromes or conditions which it is administered to treat, and is manufactured according to the specifications of the Homeopathic Pharmacopoeia of the United States (HPUS). Official homeopathic drugs are those that have been monographed and accepted for inclusion in the HPUS.
HORA - Health Occupation Revision Act of 1985 ("Act"), effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq.).
Inspection - a periodic on site review of places at which prescription drugs or devices may be produced, sold, or stored to determine compliance with applicable federal and District laws and regulations, including pre-licensure inspections performed to ensure a facility complies with applicable District law and regulations prior to receiving a license to operate in the District.
Investigation - the process of gathering and recording essential facts and observations with respect to the events and circumstances related to complaints, reported information, including interviews, reviewing records, and physical inspections to determine whether there is a violation of any applicable laws or regulations.
Institutional Facility - means any organization whose primary purpose is to provide a physical environment for patients to obtain health care services, including a(n):
(1)Hospital;
(2)Convalescent home;
(3)Nursing home;
(4)Extended care facility;
(5)Mental health facility;
(6)Rehabilitation center;
(7)Psychiatric center;
(8)Developmental disability center;
(9)Drug abuse treatment center;
(10)Family planning clinic;
(11)Penal institution;
(12)Hospice;
(13)Public health facility;
(14)Athletic facility.
Institutional pharmacy - means that physical portion of an institutional facility where drugs, devices, and other materials used in the diagnosis and treatment of injury, illness, and disease are dispensed, compounded, distributed and pharmaceutical care is provided.
Labeler - an entity or person that receives prescription drugs from a manufacturer or wholesaler and repackages those drugs for later retail sale and that has a labeler code from the federal Food and Drug Administration under 21 C.F.R. § 207.20.
Labeling - the process of affixing a label to any drug container, but does not include the labeling by a manufacturer, packer, or distributor of an over-the- counter drug, packaged legend drug, or medical device.
Mayor - the Mayor of the District of Columbia or the Mayor's designated agent.
Medical device - an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is:
(a)recognized in the official National Formulary, the official United States Pharmacopoeia, or any supplement thereto;
(b)intended for use in the diagnosis of disease or any other condition, or in the cure, mitigation, treatment, or prevention disease in a human or other animal; or
(c)intended to affect the structure of any function of the body of man or other animal, and which does achieve any of its principal intended purposes through chemical action within or on the body of a human or other animal, and which does not depend upon being metabolized for the achievement of any of its principal intended purposes.
Misbranded drug or medical device - as defined in section 501 of the Federal Food, Drug and Cosmetic Act, (Pub. L. 96-354, 21 USC § 352) as amended
Nonresident pharmacy - A pharmacy, including an internet-based pharmacy, located outside the District of Columbia which ships, mails, or delivers, in any manner, prescription drugs or prescription medical devices into the District of Columbia, whether directly or through an intermediary, pursuant to a valid prescription.
Nuclear pharmacy - a pharmacy as defined under HORA that provides those pharmacy services that are engaged in the production, distribution, and dispensing of radiopharmaceuticals.
Over-the-counter drug (Proprietary) - drugs which may be sold without a prescription and which are prepackaged for use by the consumer and labeled in accordance with the requirements of the laws and regulations of the District of Columbia and the federal government.
Person - any individual, partnership, association, corporation, company, joint stock association, or any organized group of persons whether incorporated or not, or any trustee, receiver, or assignee thereof.
Pharmaceutical Care - the provision of drug therapy and other patient care services intended to achieve outcomes related to the cure or prevention of a disease, elimination or reduction of a patient's symptoms, or arresting or slowing of a disease process.
Pharmacist - a person who is licensed to engage in the practice of pharmacy in the jurisdiction in which he or she is practicing.
Pharmacist-in-charge - a licensed pharmacist who accepts responsibility for the operation of a pharmacy and who is personally in full and actual charge of the pharmacy and pharmacy personnel.
Pharmacy - any establishment or institution, or any part thereof, where the practice of pharmacy is conducted; drugs are compounded or dispensed, offered for sale, given away, or displayed for sale at retail; or prescriptions are compounded or dispensed.
Pharmacy intern - any person who is registered in the District of Columbia to engage in the practice of pharmacy under the direct supervision of a pharmacist.
Pharmacy technician - an individual employed by a pharmacy who possesses appropriate education, training, and experience to assist in the practice of pharmacy, under the direct supervision of a pharmacist, by assisting in the technical services of preparing pharmaceuticals for final dispensing by a pharmacist.
Practice of pharmacy - the interpretation and evaluation of prescription orders; the compounding, dispensing, and labeling of drugs and devices, and the maintenance of proper records therefore; the responsibility of advising, where regulated or otherwise necessary, of therapeutic values and content, hazards, and use of drugs and devices; and the offering of performance of those acts, services, operations, and transactions necessary in the conduct, operation, management, and control of a pharmacy.
Practitioner - an individual licensed, registered, certified, or otherwise permitted by law to prescribe, dispense, and to administer drugs or medical devices, or to conduct research with respect thereto, within the course of such persons' professional practice or research.
Prescriber - a practitioner who is authorized by law to issue a prescription.
Prescription (Legend) - any order for a drug, medicinal chemical, or combination or mixtures thereof, or for a medically prescribed medical device, in writing, dated and signed by an authorized health professional or given orally to a pharmacist by an authorized health professional or the person's authorized agent and immediately reduced to writing by the pharmacist or pharmacy intern, specifying the address of the person for whom the drug or device is ordered and directions for use to be placed on the label.
Prescription drug - means any of the following:
(a)A drug which under federal law is required to be labeled with either of the following statements prior to being dispensed or delivered:
(1)"Caution: Federal law prohibits dispensing without prescription"; or
(2)"Caution: Federal law restricts this drug to use by, or on the order of, a licensed veterinarian.
(b)A drug which is required by any applicable federal, or District of Columbia law or regulation to be dispensed pursuant only to a prescription drug order; or
(c)A drug which is restricted to use by health professionals and allied practitioners for research.
Printout - a hard copy produced by a computer that is readable without the aid of any special device.
Proprietor of a pharmacy - a person designated as proprietor in an application for a pharmacy license. The proprietor may be an individual a corporation, a partnership, or an unincorporated association, and shall at all times own a controlling interest in the pharmacy.
Provider pharmacy - The community/retail pharmacy or the institutional pharmacy providing remote pharmacy services.
Qualified nuclear pharmacist - a licensed pharmacist, who is certified as a nuclear pharmacy by a certification board recognized by the Board and who has met the standards of training for NRC for medically used and radioactive by-product materials, and any other standards required by the Board or any applicable federal or District of Columbia laws or regulations.
Radiopharmaceuticals - radioactive drugs and chemicals within the classification of legend drugs as defined under the Federal Food, Drug, and Cosmetic Act, approved June 25, 1938 (21 USC §§ 301 et seq.).
Radiopharmaceutical quality assurance - means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine its suitability for use on humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.
Remote automated medication system - an automated medication system that is located in a health care facility that does not have an on-site pharmacy and in which medication is stored in a manner that may be, but need not be, patient specific.
Remote pharmacy services - The provision of pharmacy services, including the storage and dispensing of prescription drugs, in a facility that is not at the same location as the provider pharmacy.
Remote site - a facility not located at the same location as the pharmacy at which remote pharmacy services are provided using an automated medication dispensing system.
Respondent - a person, partnership, or corporation to whom the Director sends a notice of anticipated action against the license or application therefor.
Software - computer programs, procedures, and storage of required information data.
Special or limited use pharmacy - a pharmacy as defined under HORA that provides pharmacy services that are primarily for a special purpose or are limited by the type of drugs dispensed, such as sterile parenteral solutions.
Starter dose - a dose of medication removed from a remote or decentralized automated medication system within the first 24 hours after it is ordered.
Still image capture - A specific image captured electronically from a video or other image capture device.
Stop date - in institutional settings, the length of time to administer a medication as indicated by the prescribing practitioner, or established institutional policy on length of administration of drugs by category in the absence of the prescriber’s notation.
Store and forward - A video or still image record which is saved electronically for future review.
Systems back-up - (auxiliary record maintenance) hard copy, disk, tape, or equivalent used if the computer system becomes inoperative.
Telepharmacy - The practice of pharmacy through the use of a telepharmacy system.
Telepharmacy system - A system that monitors the dispensing of prescription drugs and provides for related drug use review and patient counseling services by an electronic method which shall include the use of the following types of technology:
(a)Audio and video;
(b)Still image capture; and
(c)Store and forward.