For purposes of this chapter:
(1) “Administer” means the direct application of a prescription drug, whether by injection, inhalation, ingestion, or any other means, to the body of a patient by any of the following:
a. An individual authorized by law to administer the drug, including a practitioner or an authorized agent under a practitioner’s supervision.
b. The patient at the direction of a practitioner.
(2) “Biological product” means a biological product as defined in 42 U.S.C. § 262.
(3) “Board” means the Delaware Board of Pharmacy.
(4) “Certified pharmacy technician” means an individual who is certified by the Pharmacy Technician Certification Board (PTCB) or other entity approved by the Board.
(5) “Collaborative pharmacy practice” means the practice of pharmacy whereby 1 or more pharmacists provides patient care and drug therapy management services not otherwise permitted to be performed by a pharmacist to patients under a collaborative pharmacy practice agreement with 1 or more practitioners which defines the nature, scope, conditions, and limitations of the services to be provided by the pharmacist.
(6) “Collaborative pharmacy practice agreement” means a written and signed agreement between 1 or more pharmacists and 1 or more practitioners that provides for collaborative pharmacy practice.
(7) “Compounding” means the preparation, assembling, packaging, or labeling of a drug as the result of a practitioner’s prescription or initiative based on the relationship of the practitioner or patient with the pharmacist in the course of professional practice or for the purpose of, or incident to, research, teaching, or chemical analysis and not for sale or dispensing. Compounding also includes the preparation of drugs in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns. All compounding must comply with applicable United States Pharmacopeia (“USP”) standards. Nothing in this title is meant to limit a prescriber’s ability under pre-existing law to order a compounded medication for use in the prescriber’s practice, as permitted by State of Delaware and federal law.
(8) “Controlled substance” means any drug designated as such under the Uniform Controlled Substances Act, Chapter 47 of Title 16 and 21 C.F.R. Part 1308.
(9) “Deliver” or “deliver” means the actual, constructive, or attempted transfer of a drug from 1 person to another, whether or not for consideration.
(10) “Direct supervision” means oversight and control by a licensed pharmacist who remains in the licensed establishment where the pharmacy department is located and is responsible for the work performed by support personnel.
(11) “Dispense” or “dispensing” means the procedure involving the interpretation of a practitioner’s prescription order for a drug or biological, and pursuant to that order the proper selection, measuring, compounding, labeling, and packaging in a proper container for subsequent administration to, or use by, a patient.
(12) “Division” means the Division of Professional Regulation.
(13) “Drug” means any of the following:
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.
d. A substance intended for use as a component of any substance specified in paragraph (13)a., b., or c. of this section.
“Drug” does not include devices or their components, parts, or accessories.
(14) “Executive Secretary” means the Executive Secretary of the Board, who must be a pharmacist.
(15) “Federal Food and Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations” means the publication that identifies drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 301 et seq.]. This is sometimes referred to as the “Orange Book.”
(16) “Interchangeable” means a biological product licensed by the Federal Food and Drug Administration pursuant to 42 U.S.C. § 262.
(17) “Intern” means an individual who is licensed by the Board 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.
(18) “Internship” or “externship” means a period of practical experience established by the Board’s rules and regulations that must be completed by an applicant for a license to practice pharmacy in this State.
(19) “Key personnel” means the designated representative or most senior individual responsible for facility operations, purchasing, and inventory control, the supervisor of such individual, and, if the establishment is not a publicly held company, all principals and owners who directly or indirectly own more than 10% interest in the establishment.
(20) “Label” means written, printed, or graphic matter on the immediate container of a drug.
(21) “Labeling” means the process of affixing a label, including all information required by federal and state statutes or rules and regulations, to a drug container. The term does not include any of the following:
a. The labeling by a manufacturer or distributor of a nonprescription drug or commercially packaged prescription drug.
b. Unit dose packaging.
(22) “Manufacturer” means a person who is engaged in manufacturing, but does not include a person who is engaged in the preparation and dispensing of a drug pursuant to a prescription.
(23) “Manufacturing” means the production, preparation, propagation, conversion, or processing of a drug, either directly or indirectly, by extraction from a substance of natural origin or independently by a chemical or biological synthesis. The term includes packaging or repackaging a substance or labeling or relabeling a container and promoting and marketing the drug and preparing and promoting a commercially available product from a bulk compound for resale by a person, including a pharmacy or practitioner. The term does not include compounding.
(24) “Monitoring drug therapy” means interpreting and analyzing information needed to evaluate the safety and efficacy of drug therapy.
(25) “NABP” means the National Association of Boards of Pharmacy or its successor.
(26) “Outsourcing facility” means a facility that meets all of the following:
a. Is located within the United States of America at 1 address that is engaged in the compounding of sterile drugs or nonsterile drugs.
b. Has registered as an outsourcing facility with the Food and Drug Administration under § 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 353b).
c. Is doing business within or into Delaware.
d. Is licensed with the Board as a wholesaler prior to applying to the Board to become an outsourcing facility.
e. Is licensed with the Board as an outsourcing facility.
(27) “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.
(28) “Patient counseling” means communication by a pharmacist, or registered intern or pharmacy student under direct supervision, of pertinent drug information, as specified by the Board’s rules and regulations, to a patient or caregiver to improve therapy.
(29) “Person” means as defined in § 302 of Title 1.
(30) “Pharmacist” or “licensee” means an individual licensed by this State pursuant to this chapter to engage in the practice of pharmacy.
(31) “Pharmacy” means a place where the practice of pharmacy occurs.
(32) “Pharmacy technician” means an individual working in a pharmacy practice site who, under the immediate supervision of a pharmacist, assists in pharmacy activities, as permitted by the rules and regulations of the Board, that do not require the professional judgment of a pharmacist.
(33) “Practice of pharmacy” means the interpreting, evaluating, and dispensing of a practitioner’s or prescriber’s order. The “practice of pharmacy” includes 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. The “practice of pharmacy” also includes all of the following:
a. Participation in drug utilization 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 must be reported only if outside normal limits.
f. Conducting or managing a pharmacy or other business establishment where drugs are compounded or dispensed.
g. [Repealed.]
h. Administration of injectable medications, biologicals, and immunizations pursuant to a valid prescription from a practitioner or practitioner-approved protocol approved by a physician duly licensed in this State under subchapter III of Chapter 17 of this title or a nurse duly licensed in this State under Chapter 19 of this title. Upon request, a copy of the protocol will be made available to the designated prescriber or prescribers without cost. All vaccine administrations shall be reported to DelVAX within 72 hours of administration. This report to DelVAX shall include the patient’s name, the name of the immunization, inoculations, or vaccinations administered, site of injection, lot and expiration, the facility that provided vaccination, and the date of administration, and shall be submitted electronically. Pharmacists, pharmacy interns, and nationally-certified pharmacy technicians who have completed an accredited training program, are currently trained in CPR, and have notified the Board, may administer immunizations via a prescriber’s order or protocol for patients 3 years of age and older.
i. Dispensing contraceptives or dispensing and administering injectable hormonal contraceptives under Chapter 30O of Title 16.
j. Ordering, performing, and interpreting tests authorized by the Food and Drug Administration, and waived under the federal Clinical Laboratory Improvement Amendments of 1988 [42 U.S.C. § 263a].
k. Initiating drug therapy for health conditions in accordance with § 2525 of this title.
l.Collaborative pharmacy practice in accordance with a collaborative pharmacy practice agreement.
m. Initiating, dispensing, or administering medications for human immunodeficiency virus (HIV) pre-exposure prophylaxis and HIV post-exposure prophylaxis under § 2525A of this title, which includes administering laboratory tests, conducting assessments and consultations, and providing referrals.
(34) “Practitioner” or “prescriber” means an individual who is authorized by law to prescribe drugs in the course of professional practice or by collaborative pharmacy practice agreement or research in any state.
(35) “Practitioner-dispensed topical medication” means a drug that is all of the following:
a. Dispensed by a practitioner to a patient.
b. A topical antibiotic, anti-inflammatory, dilation, or glaucoma drop or ointment.
c. On stand-by or retrieved from a dispensing system for a specified patient for use during a procedure or visit with the practitioner.
(36) “Preceptor” means an individual who is a pharmacist, meets the qualifications under the rules and regulations of the Board, and participates in the instructional training of pharmacy interns and externs.
(37) “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)).
(38) “Prescription drug order” or “prescription” means the lawful authorization for a drug by a licensed practitioner in written, verbal, electronic, or fax format and must include the information set forth in the Board’s rules and regulations.
(39) “Reference product” means a product as defined by the Federal Food and Drug Administration pursuant to 42 U.S.C. § 262.
(40) “State” means the State of Delaware.
(41) “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.
(42) “Substitution” or “substitute” means a pharmacist’s selection of prescriber authorized generic or therapeutically equivalent prescription medications or, in the case of biologicals, a pharmacist’s selection of an interchangeable biological product in place of the prescribed product. “Generic substitute” 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.”
(43) “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.
(44) “Wholesale distribution” means the distribution of drugs in compliance with federal laws and regulations, including the Drug Supply Chain Security Act [P.L. 113-54], to a person other than a consumer or patient but does not include any of the following:
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.
d. The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug under any of the following circumstances:
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.
(45) “Wholesaler” means a person engaged in the wholesale distribution of drugs, including, 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.