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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-B13. PRESCRIPTIONS AND DISTRIBUTION |
Section 22-B1399. DEFINITIONS
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1399.1As 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 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 medical device - as defined in § 501 of the Federal Food, Drug and Cosmetic Act, (Pub. L. 96-354, 21 U.S.C. § 351), as amended.
Automated data processing system - a system utilizing computer software and hardware for the purpose of recordkeeping.
Automated medication system - A robotic, computerized, or mechanical device and its components that distributes 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.)
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.
Common carrier - An organization that transports persons or goods according to defined routes and schedules and offers its services to the general public such as FedEx and UPS.
Community/Retail pharmacy - a pharmacy that provides services to the public or general community on an outpatient bases, whether at retail, through third party payment, or other measure of no or minimum cost to the consumer.
Compounding - the preparation or mixing, 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 generated facsimile - a computer to facsimile transmission sent by a computer that has a facsimile modem through which documents can be sent.
Controlled premises - (1) places where original or other records or documents required under the Act are kept or requested to be kept, and (2) places or establishments, where persons registered under the Act or exempted from registration under the Act may lawfully hold, manufacture, distribute, dispense, conduct research with, or otherwise dispose of controlled substances.
Controlled substances - those drug items or chemicals regulated under the Federal Controlled Substances Act of 1970, (Pub. L. 91-513, 21 U.S.C. §§ 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.
Courier - An individual or entity that is hired to take parcels directly from one place to another.
DEA - The United States Drug Enforcement Administration.
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.
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.
Dispensing pharmacist - A pharmacist who, in the process of dispensing a prescription medication after the complete preparation of the prescription medication and before delivery of the prescription medication to a patient or patient's agent, verifies, checks, and initials the medication record.
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.
Drug -
(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 not including medical devices or their components, parts, or accessories.
Electronic - relating to technology having electrical, digital, magnetic, wireless, optical, electromagnetic, or similar capabilities.
Electronic prescription - a prescription drug order which is transmitted by an electronic device to the receiver (pharmacy), or which is transmitted computer to computer between a practitioner's office and a pharmacy, and which contains an electronic signature. An electronic prescription includes computer generated facsimile prescription drug orders but does not include telephone facsimile prescription drug orders.
Electronic record - a record created, generated, sent, communicated, received, or stored by electronic means.
Electronic signature - a confidential, unique, personalized electronic security code, key, number or other identifier attached to or logically associated with a record that is used for secure electronic data transmissions which identifies and authenticates the signatory and is executed or adopted by the signatory with the intent to sign the record.
Generically equivalent drugs - drugs that are:
(a)Pharmaceutical equivalents in that they contain identical amounts of the same active drug ingredients in the same dosage form and meet compendial or other applicable standards of identity strength, quality, and purity;
(b)Bioequivalents in that they do not present a known or potential bioequivalence problem or if they do present such a known or potential problem they are shown to meet an appropriate bioequivalence standard; and
(c)Adequately labeled and are manufactured under conditions which, at a minimum, comply with FDA Current Good Manufacturing Practice Regulations.
HIPAA - The Federal Health Insurance Portability and Accountability Act of 1996.
Individual Practitioner - an individual who is licensed or registered in the District of Columbia to prescribe a prescription drug or medical device in the course of his or her professional practice, including a physician, dentist, veterinarian, podiatrist, optometrist, or advanced practice nurse. It does not include a pharmacist, pharmacy, or an institutional practitioner.
Institutional practitioner - an intern, resident physician, fellow, or person in an equivalent professional position who:
(a)Is not yet licensed under District of Columbia law to administer, dispense, or prescribe controlled substances;
(b)Is enrolled in a bona fide professional training program in a base hospital or institutional training facility registered by the Federal Drug Enforcement Administration and District of Columbia; and
(c)Is authorized by the base hospital or institutional training facility to administer, dispense, or prescribe controlled substances.
Linked pharmacy system - pharmacies within the same retail name chain utilizing a Common electronic file or database to transfer prescription drug orders or information for dispensing purposes between or among pharmacies within the same retail chain which also participates in the same common prescription file.
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 man 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 man 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 U.S.C. § 352), as amended.
Narcotic Drug - any of the following whether produced directly or indirectly by extraction from substances of vegetable origin or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis:
(a)Opium, opiates, derivatives of opium and opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers and salts is possible within the specific chemical designation. Such term does not include the isoquinoline alkaloids of opium;
(b)Poppy straw and concentrate of poppy straw;
(c)Coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine and derivatives of ecgonine or their salts have been removed;
(d)Cocaine, its salts, optical and geometric isomers, and salts of isomers;
(e)Ecgonine, its derivatives, their salts, isomers and salts of isomers; or
(f)Any compound, mixture, or preparation which contains any quantity of these substances.
Narcotic treatment program - a program engaged in maintenance or detoxification treatment with narcotic drugs.
Non-Prescription drug - A drug which may be sold without a prescription and which is labeled for use by the consumer in accordance with the requirements of the laws and rules of the District of Columbia and the federal government and includes both the classifications over-the-counter drugs and restricted drugs.
Original prescription - the original written prescription drug order; the original oral drug order that has been reduced to writing by the pharmacist; the original telephone facsimile prescription, or the original electronic prescription.
Over-the-counter drug - drugs which may be sold without a prescription and which are packaged 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.
Patient - practitioner relationship - means that at a minimum the practitioner has met face to face with the patient, has obtained a patient history, and conducted a physical examination or evaluation adequate to establish a diagnosis, identify underlying conditions and contraindications to the treatment recommended.
Pharmacist - a person who is licensed in the District of Columbia to engage in the practice of pharmacy.
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.
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 - the practitioner who issues a prescription.
Prescription - 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 - any of the following:
(a)A drug which is required under federal law 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 other 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 is restricted to use by practitioners only; or
(c)A drug which is restricted to use by health professionals and allied practitioners for research.
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 pharmacy or the institutional pharmacy providing remote pharmacy services.
Registrant - a person who is registered under the District of Columbia Uniformed Controlled Substances Act of 1981, effective August 5, 1981 (D. C. Law 4-29; D.C. Official Code § 48-901.01).
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.
Restricted drug— A drug for which a prescription is not required that pursuant to District of Columbia or federal law or regulation must be stored behind the pharmacy counter and which shall not be directly accessible to the public.
Reverse distributor - a duly authorized party who receives drugs, including controlled substances, acquired from another duly authorized party for the purpose of:
(a)returning unwanted, unusable, or outdated controlled substances to the manufacturer or the manufacturer's agent; or
(b)where necessary, processing such substances or arranging for processing such substances for disposal.
Starter dose - a dose of medication removed from a remote or decentralized automated medication system within the first 24 hours after it is ordered.
Security procedure - a procedure employed for the purpose of verifying that an electronic signature, record, or performance is that of a specific person or for detecting changes or errors in the information in an electronic record. The term includes a procedure that requires the use of algorithms or other codes, identifying words or numbers, encryption, or callback or other acknowledgment procedures.
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.
Telephone Facsimile prescription - a prescription drug order which is transmitted by Telephone electronic device which sends an exact image to the receiver (pharmacy).
Therapeutic interchange - The dispensing of chemically different drugs that are considered to be therapeutically equivalent.
Therapeutically equivalent drugs - Drug products that are chemically dissimilar but produce essentially the same therapeutic outcome and have similar toxicity profiles. Usually these drugs are within the same pharmacologic class. They frequently differ in chemistry, mechanism of action, and pharmacokinetic properties, and may possess different adverse reaction, toxicity, and drug interaction profiles.