The following words, terms, and phrases when used in this chapter have the meanings ascribed to them in this section, except where the context clearly indicates a different meaning.
(1) ”Biological product” means a biological product as defined in § 351 of the Public Health Service Act (42 U.S.C. § 262).
(2) ”Board,” “Board of Pharmacy,” or “State Board of Pharmacy” means the Delaware State Board of Pharmacy.
(3) ”Certified pharmacy technician” means a person who is certified by the Pharmacy Technician Certification Board (PTCB) or other entity approved by the Board of Pharmacy.
(4) ”Direct supervision” means oversight and control by a licensed pharmacist who remains on the premises and is responsible for the work performed by a subordinate.
(5) ”Dispense” means to furnish or deliver a drug to an ultimate user by or pursuant to the lawful prescription of a practitioner. Dispense includes the preparation, packaging, labeling, or compounding necessary to prepare a drug for furnishing or delivery.
(6) ”Distant site” means a site at which a health-care provider legally allowed to practice in the State is located while providing health-care services by means of telemedicine or telehealth.
(7) ”Division” means the Division of Professional Regulation.
(8) ”Drug” means:
a. A substance recognized as a drug in the Official United States Pharmacopoeia/National Formulary;
b. A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of any illness, condition, or disease in humans or animals;
c. A substance, other than food, intended to affect the structure or any function of the body of a human or an animal; or
d. A substance intended for use as a component of any substance specified in paragraph (8)a., b. or c. of this section.
“Drug” does not include devices or their components, parts, or accessories.
(9) ”Drug outlet” means a pharmacy, an in-state or out-of-state drug wholesaler, a drug manufacturer, a drug distributor, or a nonpharmacy veterinary drug seller.
(10) ”Executive Secretary” means the executive secretary of the Delaware State Board of Pharmacy who shall be a pharmacist.
(11) ”Federal Food and Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations” means the publication with that title containing a list of prescription drugs by generic name.
(12) ”Interchangeable” means a biological product licensed by the Federal Food and Drug Administration pursuant to 42 U.S.C. § 262(k)(4).
(13) ”Intern” means a person who is registered by the Board of Pharmacy and supervised by an approved preceptor and who is completing the practical experience requirement of the Board prior to that person’s licensure as a pharmacist.
(14) ”Internship” or “externship” means a period of practical experience established by Board of Pharmacy regulation that must be completed by an applicant for a license to practice pharmacy in this State.
(15) ”Manufacturer” means a person who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a drug, but does not include a person who is engaged in the preparation and dispensing of a drug pursuant to a prescription.
(16) ”Monitoring drug therapy” means interpreting and analyzing information needed to evaluate the safety and efficacy of drug therapy.
(17) ”Originating site” means a site in Delaware at which a patient is located at the time health-care services are provided to him or her by means of telemedicine or telehealth, unless the term is otherwise defined with respect to the provision in which it is used; provided, however, notwithstanding any other provision of law, insurers and providers may agree to alternative siting arrangements deemed appropriate by the parties.
(18) ”Over-the-counter product” or “OTC” means a substance which may be sold without a prescription and which is packaged for use by the consumer and labeled in accordance with the requirements of state and federal statutes and regulations.
(19) ”Person” means a natural person or an entity.
(20) ”Pharmacist” or “licensee” means an individual licensed by the State pursuant to this chapter to engage in the practice of pharmacy.
(21) ”Pharmacy” means a place where drugs are compounded or dispensed.
(22) ”Pharmacy technician” means an individual who is not registered as an intern with the Board of Pharmacy or a certified pharmacy technician.
(23) ”Practice of pharmacy” means the interpreting, evaluating, and dispensing of a practitioner’s or prescriber’s order. The practice of pharmacy includes, but is not limited to, the proper compounding, labeling, packaging, and dispensing of a drug to a patient or the patient’s agent, and administering a drug to a patient. The practice of pharmacy includes the application of the pharmacist’s knowledge of pharmaceutics, pharmacology, pharmacokinetics, drug and food interactions, drug product selection, and patient counseling. It also includes:
a. Participation in drug utilization and/or drug regimen reviews;
b. Participation in therapeutic drug selection, substitution of therapeutically equivalent drug products;
c. Advising practitioners and other health-care professionals, as well as patients, regarding the total scope of drug therapy, so as to deliver the best care possible;
d. Monitoring drug therapy;
e. Performing and interpreting capillary blood tests to screen and monitor disease risk factors or facilitate patient education, the results of which must be reported to the patient’s health-care practitioner; screening results to be reported only if outside normal limits;
f. Conducting or managing a pharmacy or other business establishment where drugs are compounded or dispensed;
g. The use of telemedicine and participation in telehealth in a manner deemed appropriate by regulation; and
h. Administration of injectable medications, biologicals and adult immunizations pursuant to a valid prescription or physician-approved protocol approved by a physician duly licensed in the State under subchapter III of Chapter 17 of this title. Pharmacists shall request which physician or physicians and notify the physician or physicians as designated by the patient of such administration within 24 hours. The notice shall include the patient’s name, the name of the immunizations, inoculations or vaccinations administered, and the date of administration and may be submitted by phone, fax, post or electronically. Upon request a copy of the protocol will be made available to the designated physician or physicians without costs.
(24) ”Practitioner” or “prescriber” means an individual who is authorized by law to prescribe drugs in the course of professional practice or research in any state.
(25) ”Preceptor” means a licensed pharmacist who is approved by the Board to supervise an intern.
(26) ”Prescription drug” or “legend drug” means a drug required by federal or state law or regulation to be dispensed only by a prescription, including finished dosage forms and active ingredients, subject to § 503(b) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 353(b)).
(27) ”Prescription drug order” or “prescription” means the lawful written or verbal order of a practitioner for a drug.
(28) ”Reference product” means a product as defined by the Federal Food and Drug Administration pursuant to 42 U.S.C. § 262.
(29) ”State” means the State of Delaware.
(30) ”Store and forward transfer” means the transmission of a patient’s medical information either to or from an originating site or to or from the provider at the distant site, but does not require the patient being present nor must it be in real time.
(31) ”Substantially related” means the nature of the criminal conduct, for which the person was convicted, has a direct bearing on the fitness or ability to perform 1 or more of the duties or responsibilities necessarily related to the practice of pharmacy.
(32) ”Substitution” or “substitute” means pharmacist’s selection of prescriber authorized generic or therapeutically equivalent prescription medications or, in the case of biologicals, pharmacist selection of an interchangeable biological product in place of the prescribed product. Generic substitution means a drug that is the same active ingredient, equivalent in strength to the strength written on the prescription and which is classified as being therapeutically equivalent to another drug in the latest edition or supplement of the Federal Food and Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, sometimes referred to as the “Orange Book.”
(33) ”Telehealth” means the use of information and communications technologies consisting of telephones, remote patient monitoring devices or other electronic means which support clinical health care, provider consultation, patient and professional health-related education, public health, health administration, and other services as described in regulation.
(34) ”Telemedicine” means a form of telehealth which is the delivery of clinical health-care services by means of real time 2-way audio, visual, or other telecommunications or electronic communications, including the application of secure video conferencing or store and forward transfer technology to provide or support health-care delivery, which facilitate the assessment, diagnosis, consultation, treatment, education, care management and self-management of a patient’s health care by a licensee practicing within his or her scope of practice as would be practiced in-person with a patient and with other restrictions as defined in regulation.
(35) ”Therapeutically equivalent drug” means a drug which contains the same active ingredient or ingredients and is identical in strength or concentration, dosage form, and route of administration and which is classified as being therapeutically equivalent to another drug in the latest edition or supplement of the Federal Food and Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, Evaluations, sometimes referred to as the Orange Book.
(36) ”Use or abuse of drugs” means:
a. The use of illegal drugs;
b. The use of prescription drugs without a prescription; or
c. The excessive use or abuse of alcoholic beverage or drugs to the extent that it impairs a pharmacist’s ability to perform the work of a pharmacist.
(37) ”Wholesale distribution” means the distribution of drugs to a person other than a consumer or patient. Wholesale distribution does not include:
a. The distribution of drugs within a healthcare group-purchasing organization;
b. The transfer of prescription drugs by a pharmacy to another pharmacy to alleviate a temporary shortage;
c. The dispensing of a drug pursuant to a prescription; or
d. The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug:
1. By a charitable organization described in § 501(c)(3) of the Internal Revenue Code of 1954 (26 U.S.C. § 501(c)(3)) to a nonprofit affiliate of the charitable organization to the extent permitted by law;
2. Among hospitals or other health care entities which are under common control;
3. For emergency medical reasons.
(38) ”Wholesale distributor” means a person engaged in the wholesale distribution of drugs, including, but not limited to, a manufacturer’s or distributor’s warehouse, a chain drug warehouse or wholesale drug warehouse, an independent wholesale drug trader, and a pharmacy that engages in the wholesale distribution of drugs.
Terms Used In Delaware Code Title 24 Sec. 2502
- Oversight: Committee review of the activities of a Federal agency or program.
- State: means the State of Delaware; and when applied to different parts of the United States, it includes the District of Columbia and the several territories and possessions of the United States. See Delaware Code Title 6 Sec. 4307
- United States: includes its territories and possessions and the District of Columbia. See Delaware Code Title 6 Sec. 4307