Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 15 - Pharmacy › Part 1 - Pharmacists, Pharmacies, and Manufacturers, Wholesalers, and Distributors › Section 216-RICR-40-15-1.2 - Definitions

Current through June 14, 2024
A. Wherever used in this Part the following
				  terms shall be construed as follows:
1. "ACPE"
				  means Accreditation Council for Pharmacy Education.
2. "Act" means R.I. Gen. Laws Chapter
				  5-19.1 entitled,
				  "Pharmacies."
3. "Active
				  ingredient" means any component that provides pharmacological activity or other
				  direct effect in the diagnosis, cute, mitigation, treatment or prevention of
				  disease or to affect the structure or any function of the body of man or
				  animals.
4. "Actively reports"
				  means reporting all dispensing errors and analyses of such errors to a patient
				  safety organization as soon as practical but no later than thirty (30) days of
				  identification of the error.
5.
				  "Administer" or "Administration" means the direct application of - medications
				  to the body of a patient or research subject by a practitioner by injection,
				  inhalation, ingestion, or any other means.
6. "Adverse drug reaction" means any
				  undesirable or unexpected medication related event that requires discontinuing
				  a medication or modifying the dose, requires or prolongs hospitalization,
				  results in disability, requires supportive treatment, is life-threatening or
				  results in death, results in congenital anomalies, or occurs following
				  vaccination.
7. "Assisted living
				  residence licensed at the M-1 level" or "Assisted living residence" means a
				  publicly or privately operated residence that provides directly or indirectly
				  by means of contracts or arrangements personal assistance to meet the
				  resident's changing needs and preferences, including central storage and/or
				  administration of medications, lodging, and meals, to six (6) or more adults
				  who are unrelated to the licensee or administrator, excluding however, any
				  privately operated establishment or facility licensed pursuant to R.I. Gen.
				  Laws Chapter
				  23-17 and those facilities
				  licensed by or under the jurisdiction of the Department of Behavioral
				  Healthcare, Developmental Disabilities and Hospitals, the Department of
				  Children, Youth, and Families, or any other state agency. Assisted living
				  residences include sheltered care homes, board and care residences, and any
				  other entity by any other name providing the above services.
8. "Authentication of product history" means,
				  but is not limited to, identifying the purchasing source, the ultimate fate,
				  and any intermediate handling of any component of a
				  radiopharmaceutical.
9.
				  "Auto-substitute" means the replacing of the prescribed product with either a
				  generic product, another brand of the prescribed product, a product with the
				  same active ingredient but different inactive ingredients or a different drug
				  within the same therapeutic class as the prescribed product, without being
				  required to obtain prescriber authorization.
10. "Automated dispensing system" means a
				  computerized system for dispensing prepackaged medications in manufacturer
				  labeled, unit-of-use doses.
11.
				  "Automated filling system" means an automated system used within a pharmacy to
				  assist in filling a prescription drug order by selecting, labeling, filling, or
				  sealing medication for dispensing. An "automated filling system" shall not
				  include automated devices used solely to count medication or vacuum tube drug
				  delivery systems.
12. "Automated
				  pharmacy system" means a mechanical system, located within or adjacent to the
				  prescription department, or at a remote location, that performs operations or
				  activities, other than compounding or administration, relative to storage,
				  packaging, dispensing, or distribution of medication, and which collects,
				  controls, and maintains all transaction information.
13. "Automated storage and distribution
				  devices" means a mechanical device that delivers drugs other than by
				  administration, and uses automated data processing technology to:
a. Provide effective storage and security of
				  drugs contained in the device;
b.
				  Limit access to authorized individuals;
c. Record the identity of all personnel who
				  access the drugs stored within the device;
d. Provide documentation of storage and
				  removal of contents;
e. Provide
				  ongoing documentation that monitors proper delivery of drugs to ensure patient
				  safety;
f. Comply with Rhode Island
				  General Laws and Regulations.
14. "Batch compounding" means the act of
				  compounding multiple containers/doses of a drug product or other material with
				  uniform character and quality, within specified limits, that are prepared in
				  anticipation of physician/prescription drug orders or approved
				  protocol/procedure based on routine, regularly observed prescribing
				  patterns.
15. "Beyond use dating"
				  means:
a. The date or time beyond which a drug
				  preparation is not recommended to be dispensed, administered, stored, or
				  transported.
b. Beyond Use Dating
				  shall be determined from the date and time the drug preparation is compounded.
				  Administration times (also known as "hang times") shall not exceed twenty-four
				  (24) hours from the established beyond use dating on the dispensed product
				  unless shorter administration times are required by the manufacturer's
				  specifications/literature.
16. "Biological product"' means a virus,
				  therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or
				  derivative, allergenic product, or analogous product, or arsphenamine or
				  derivative of arsphenamine (or any other trivalent organic arsenic compound),
				  applicable to the prevention, treatment, or cure of a disease or condition of
				  human beings as defined in the Public Health Service Act,
				   42 U.S.C. §
												262.
17. "Biosimilar" means a product is a
				  biological product that is approved based on a showing that it is highly
				  similar to an FDA-approved biological product, known as a reference product,
				  and has no clinically meaningful differences in terms of safety and
				  effectiveness from the reference product. Only minor differences in clinically
				  inactive components are allowable in biosimilar products.
18. "Blister packages" means multi-dose
				  containers of a specific medication repackaged by the pharmacy in accordance
				  with §1.1.7 of this Part and intended for a specific patient.
19. "Blood" means whole blood collected from
				  a single donor and processed either for transfusion or further
				  manufacturing.
20. "Blood
				  component" means that part of blood separated by physical or mechanical
				  means.
21. "Board" means the Board
				  of Pharmacy within the Department of Health established pursuant to R.I. Gen.
				  Laws §
											5-19.1-3.
22. "Call center operation" means any
				  operation that functions as a shared order processing facility but is not
				  licensed as a pharmacy.
23.
				  "Central fill pharmacy" means the pharmacy that fills the prescription order
				  for delivery in accordance with an agreement with another pharmacy or
				  pharmacies.
24. "Change of
				  ownership" means:
a. In the case of a
				  pharmacy, manufacturer or wholesaler which is a partnership which results in a
				  new partner acquiring a controlling interest in the partnership;
b. In the case of a pharmacy, manufacturer or
				  wholesaler which is a sole proprietorship, the transfer of the title and
				  property to another person;
c. In
				  the case of a pharmacy, manufacturer or wholesaler which is a corporation:
(1) A sale, lease exchange, or other
				  disposition of all, or substantially all of the property and assets of the
				  corporation; or
(2) A merger of the
				  corporation into another corporation; or
(3) The consolidation of two (2) or more
				  corporations, resulting in the creation of a new corporation; or
(4) In the case of a pharmacy, manufacturer
				  or wholesaler which is a business corporation, any transfer of corporate stock
				  which results in a new person acquiring a controlling interest in the
				  corporation; or
(5) In the case of
				  a pharmacy, manufacturer or wholesaler which is a nonbusiness corporation, any
				  change in membership which results in a new person acquiring a controlling vote
				  in the corporation.
25. "Clinic" means a health facility
				  providing healthcare services to individuals associated with a college or
				  university.
26. "Collaborative
				  pharmacy practice" is that practice of pharmacy pursuant to R.I. Gen. Laws
				  Chapter 5-19.2 whereby one (1) or more
				  licensed pharmacist(s), with advanced training and experience relevant to the
				  scope of collaborative practice, agrees to work in collaboration with one (1)
				  or more physician(s) for the purpose of drug therapy management of patients,
				  such management to be pursuant to a protocol or protocols authorized by the
				  physician(s) and subject to conditions and/or limitations as set forth by the
				  Department. A health care professional who has prescribing privileges and is
				  employed by a collaborating physician may be in such an agreement.
27. "Collaborative practice agreement" is a
				  written and signed agreement, entered into voluntarily, between one (1) or more
				  pharmacist(s) with advanced training and experience relevant to the scope of
				  collaborative practice and one (1) or more physician(s) that defines the
				  collaborative pharmacy practice in which the pharmacist(s) and physician(s)
				  propose to engage. Collaborative practice agreements shall be made in the best
				  interest of public health.
28.
				  "Collaborative practice committee" shall consist of six (6) individuals: three
				  (3) individuals to be appointed by the Board of Pharmacy from nominees provided
				  by the Rhode Island Pharmacists Association; and three (3) individuals to be
				  appointed by the Board of Medical Licensure and Discipline from nominees
				  provided by the Rhode Island Medical Society. The Collaborative Practice
				  Committee shall advise the Director on all issues pertinent to the regulation
				  of collaborative practice agreements.
29. "Complex non-sterile drug preparation"
				  means:
a. A compounded drug preparation which
				  requires special training, special environment, special facilities, or
				  equipment.
b. Compounding
				  techniques and procedures that may present an elevated risk to the compounder
				  or the patient.
c. Complex
				  Non-Sterile Drug Preparation shall be consistent with the category of complex
				  non-sterile compounding described in current USP chapter
				  795.
30. "Compounded
				  sterile preparations" or "CSPs" means a sterile drug or nutrient compounded in
				  a licensed pharmacy or other healthcare-related facility pursuant to the order
				  of a licensed prescriber; the article may or may not contain sterile
				  products.
31. "Compounding" shall
				  be the act of combining two (2) or more ingredients as a result of a
				  practitioner's prescription or medication order occurring in the course of
				  professional practice based upon the individual needs of a patient and a
				  relationship between the practitioner, patient, and pharmacist. Compounding
				  does not mean the routine preparation, mixing, reconstitution or assembling of
				  drug products that are essentially copies of a commercially available product.
				  Pharmacy compounding includes the preparation of drugs or devices pursuant to a
				  prescription or medication order or in anticipation of prescription or
				  medication orders based upon routine, regularly observed prescribing
				  patterns.
32. "Compounding
				  accountability document" means:
a. Formulation
				  of the compounded product.
b. Lot
				  numbers, expiration dates, and beyond use dates of all chemicals used in the
				  preparation of the finished compounded product.
c. Initials to identify pharmacist and
				  technician involved in the preparation of the finished compounded
				  product.
33.
				  "Confidential information" means healthcare and other information maintained by
				  the pharmacist in the patient's records, which is deemed confidential by virtue
				  of the provisions of R.I. Gen. Laws Chapter
				  5-37.3, and any other Federal or
				  State law.
34. "Contact hour" means
				  a unit of measure of educational credit as defined by ACPE.
35. "Consultant pharmacist" means a
				  pharmacist licensed to engage in the practice of pharmacy in this State who is
				  responsible for developing, coordinating, and supervising pharmaceutical
				  services in a nursing facility, assisted living residence, medical institution,
				  or hospice care facility.
36.
				  "Continuing education" means accredited or approved post-licensure professional
				  pharmaceutical education designed to maintain and improve competence in the
				  practice of pharmacy, pharmacy skills, and preserve pharmaceutical standards
				  for the purpose of protecting public health, safety, and welfare. Continuing
				  education programs shall address topics and subject matter areas which are
				  pertinent to the contemporary practice of pharmacy.
37. "Continuing education unit" (CEU) means a
				  unit of measure of educational credit which is equivalent to ten (10)
				  hours.
38. "Controlled substance"
				  means a drug or substance, or an immediate precursor of such drug or substance,
				  so designated under or pursuant to the provisions of R.I. Gen. Laws Chapter
				  21-28.
39. "Correctional facility" means any
				  facility in the State of Rhode Island for the confinement or rehabilitation of
				  offenders or individuals charged with or convicted of criminal
				  offenses.
40. "Counseling" means
				  the oral communication by the pharmacist of information, as defined in the
				  rules of the Board, to the patient or care giver, in order to improve therapy
				  by ensuring proper use of drugs and devices.
41. "COVID-19" means the disease cause by the
				  novel coronavirus SARS-CoV-2.
42.
				  "Deliver" or "Delivery" means the actual, constructive, or attempted transfer
				  from one (1) person to another of a drug or device whether or not there is an
				  agency relationship.
43.
				  "Department" means the Rhode Island Department of Health.
44. "Digital signature" means an electronic
				  signature based upon cryptographic methods of originator authentication, and
				  computed by using a set of rules and a set of parameters that identify the
				  signer so that the integrity of the data can be verified.
45. "Delivery pharmacy" means the pharmacy
				  that delivers the filled prescription medication to the patient.
46. "Device" means an instrument, apparatus,
				  and contrivances, including their components, parts and accessories, intended:
a. For use in the diagnosis, cure,
				  mitigation, treatment, or prevention of disease in humans or other animals; or
b. To affect the structure or any
				  function of the body of man or other animals.
47. "Director" means the Director of the
				  Rhode Island state Department of Health or his/her subordinates to whom the
				  Director has delegated the powers and duties vested in the Director by these
				  Regulations. The terms Department or Director may be used interchangeably
				  unless clearly indicated otherwise by the context of the sentence in which it
				  appears.
48. "Discontinuance" means
				  the action of terminating by discontinuing, suspending, or revoking any license
				  for good and sufficient cause.
49.
				  "Dispensary" shall have the same meaning as "clinic."
50. "Dispense" or "Dispensing" means the
				  interpretation of a prescription or order for a drug, biological, or device
				  and, pursuant to that prescription or order, the proper selection, measuring,
				  compounding, labeling, or packaging necessary to prepare that prescription or
				  order for delivery or administration.
51. "Dispense as written" means the
				  prescriber's instructions regarding authorization for substitutions with
				  generic equivalents or ordering of the specific prescribed medication with
				  instructions on the prescription stating "DO NOT SUBSTITUTE".
52. "Dispensing error" means one (1) or more
				  of the following discovered after the final verification by the pharmacist and
				  after receipt of the drug by the patient:
a.
				  Variation from the prescriber's prescription drug order, including but not
				  limited to:
(1) Incorrect drug;
(2) Incorrect drug strength;
(3) Incorrect dosage form;
(4) Incorrect patient; or
(5) Inadequate or incorrect packaging,
				  labeling, or directions.
b. Failure to exercise professional judgment
				  in identifying and managing:
(1) Known
				  therapeutic duplication;
(2) Known
				  drug-disease contraindications;
(3)
				  Known drug-drug interactions;
(4)
				  Incorrect drug dosage or duration of drug treatment;
(5) Known drug-allergy
				  interactions;
(6) A clinically
				  significant, avoidable delay in therapy; or
(7) Any other significant, actual, or
				  potential problem with a patient's drug therapy.
c. Delivery of a drug to the incorrect
				  patient.
d. Variation in bulk
				  repackaging or filling of automated devices, including but not limited to:
(1) Incorrect drug;
(2) Incorrect drug strength;
(3) Incorrect dosage form; or
(4) Inadequate or incorrect packaging or
				  labeling.
53.
				  "Dispensing error analysis" means a review of the findings collected and
				  documented on each dispensing error, assessment of the cause and any factors
				  contributing to the dispensing error, and any recommendation for remedial
				  action to improve pharmacy systems and workflow processes to prevent or reduce
				  future errors.
54. "Distribute"
				  means the delivery of a drug other than by administering or
				  dispensing.
55. "Drug" means:
a. Articles recognized in the official United
				  States Pharmacopeia, or the official Homeo-pathic Pharmacopeia of the United
				  States;
b. Substances intended for
				  use in the diagnosis, cure, mitigation, treatment, or prevention of disease in
				  man, woman or other animals;
c.
				  Substances (other than food) intended to affect the structure of any function
				  of the body of man, woman or other animals;
d. Substances intended for use as a component
				  of any substances specified here above or as a "
Error! Reference source
				  not found.
" or "
Error! Reference source not found.
" defined
				  in these Regulations, but not including devices or their component parts or
				  accessories.
56. "Drug
				  regimen review" includes but is not limited to the following activities:
a. Evaluation of the prescriptions and
				  patient records for:
(1) Known
				  allergies;
(2) Rational
				  therapy-contraindications;
(3)
				  Reasonable dose and route of administration;
(4) Reasonable directions for use,
				  and
(5) Evaluation of the
				  prescriptions and patient records for duplication of therapy.
b. Evaluation of the prescriptions
				  and patient records for interactions:
(1)
				  Drug-drug;
(2) Drug-food;
(3) Drug-disease;
(4) Adverse drug reactions, and
(5) Idiosyncratic reactions.
c. Evaluations of the
				  prescriptions and patient records for proper utilization (including over-and
				  under-utilization), and optimum therapeutic outcomes.
57. "DEM" means the Rhode Island Department
				  of Environmental Management.
58.
				  "Drug sample" means a unit of a prescription drug that is not intended to be
				  sold and is intended to promote the sale of the drug.
59. "Drugs establishment" refers to any
				  business eligible to hold a Federal Registration of Drug Establishment, issued
				  by the Federal Food and Drug Administration of the United States Department of
				  Health and Human Services (or a successor agency).
60. "Drug" has the same meaning set forth in
				  R.I. Gen. Laws §
											5-19.1-2(k).
61. "Drug therapy management" means the
				  review, in accordance with a collaborative practice agreement, of drug therapy
				  regimen or regimens of patients by one (1) or more licensed pharmacist(s) for
				  the purpose of initiating, adjusting, monitoring, or discontinuing the regimen.
				  Decisions involving drug therapy management shall be made in the best interests
				  of the patient. In accordance with a collaborative practice agreement, drug
				  therapy management may include:
a. Initiating,
				  adjusting, monitoring, or discontinuing drug therapy;
b. Collecting and reviewing patient
				  histories;
c. Obtaining and
				  checking vital signs, including pulse, height, weight, temperature, blood
				  pressure, and respiration; and
d.
				  Ordering and evaluating the results of laboratory tests directly related to
				  drug therapy when performed in accordance with approved protocols applicable to
				  the practice setting and providing such evaluation does not include any
				  diagnostic component.
62.
				  "Electronic medical record" (eMAR) is an electronically stored report that
				  serves as a record of the drugs administered to a patient at a facility by a
				  health care professional. The eMAR is a part of a patient's permanent record on
				  his/her medical chart.
63.
				  "Electronic signature" means an electronic sound, symbol, or process attached
				  to or logically associated with a record and executed or adopted by a person
				  with the intent to sign the record.
64. "Electronic transmission prescription"
				  means any prescription, other than an oral or written prescription, that is
				  electronically transmitted from a practitioner authorized to prescribe to a
				  pharmacy without alteration by a third (3rd) party
				  unless authorized by the prescribing practitioner or from one (1) pharmacy to
				  another pharmacy.
65. "Emergency
				  drug kit" means a select supply of drugs and/or biologicals located at a
				  nursing facility, assisted living residence, medical institution, or hospice
				  care facility, except as prohibited by other statutes or Regulations, for the
				  immediate administration to patients upon the medical order of an authorized
				  prescriber.
66. "Equivalent and
				  interchangeable" means having the same generic name, dosage form, and labeled
				  potency, meeting standards of the United States Pharmacopoeia or National
				  Formulary, or their successors, if applicable, and not found in violation of
				  the requirements of the United States Food and Drug Administration, or its
				  successor agency, or the Rhode Island Department of Health.
67. "Facsimile (FAX) prescription" means a
				  written prescription or order that is transmitted by an electronic device that
				  sends the exact image to the receiver (pharmacy) in a hard copy form.
68. "FDA-approved product" means any drug or
				  device that has received United States Food and Drug Administration (FDA)
				  approval, including being manufactured in an FDA-approved facility.
69. "Financial interest" means financial
				  benefit gained by any practitioner with authority to prescribe drugs and
				  includes such benefit derived by a spouse or dependent child.
70. "Foreign pharmacy graduate" is a
				  pharmacist whose undergraduate pharmacy degree was conferred outside the United
				  States by a pharmacy school listed in the World Directory of Schools of
				  Pharmacy published by the World Health Organization. The United States, as used
				  here, includes the fifty (50) States, the District of Columbia, and Puerto
				  Rico.
a. "FPGEC" means the Foreign Pharmacy
				  Graduate Equivalency Commission.
b.
				  "FPGEE" means the Foreign Pharmacy Graduate Equivalency Examination.
c. "TOEFL" is the Test of English as a
				  Foreign Language, as given by the American College Testing (ACT), or its
				  successor, and certified by the FPGEC.
d. "Test of Spoken English (TSE)" means the
				  test of spoken English administered by the Educational Testing
				  Service.
71. "High-risk
				  compounded sterile products" means products compounded under conditions that
				  are at a high risk of becoming contaminated with an infectious microorganism.
				  High risk conditions shall include: using non-sterile ingredients or a
				  non-sterile device in the preparation of the final product; sterile contents
				  that lack effective antimicrobial preservatives and packaging containers that
				  are exposed to air quality inferior to ISO Class 5 before sterilization;
				  procedures such as weighing and mixing conducted in air quality inferior to ISO
				  Class 7; the chemical purity and content strength of ingredients used are not
				  verified to meet their original or compendial specifications in packages of
				  bulk ingredients.
72. "Hazardous
				  drug" means any drug identified on the NIOSH or DEM lists that has the
				  potential to cause carcinogenicity, teratogenicity, developmental toxicity,
				  reproductive toxicity in humans, organ toxicity at low dose in humans or
				  animals, genotoxicity, or new drugs that mimic existing hazardous drugs in
				  structure or toxicity.
73. "Hospice
				  care facility" means an inpatient setting where palliative and supportive
				  services to the terminally ill and their families are provided.
74. "Hospital" means a facility with a
				  governing body, an organized medical staff and a nursing service providing
				  equipment and services primarily to inpatient care to persons who require
				  definitive diagnosis and treatment for injury, illness or other disabilities or
				  pregnancy, licensed pursuant to R.I. Gen. Laws Chapter
				  23-17.
75. "Immunizing pharmacist" means a
				  pharmacist who is certified to administer adult and pediatric vaccinations in
				  accordance with these Regulations.
76. "Institutional pharmacy" means any
				  pharmacy:
a. Located within or
b. Off-site and contracted with any hospital,
				  clinic or dispensary in which drugs are compounded or dispensed to its patients
				  or patients of another licensed in-patient healthcare facility with whom it has
				  a contract.
77.
				  "Interchangeable biological product" means biosimilar to an FDA-approved
				  reference product and meets additional standards for interchangeability. An
				  interchangeable biological product may be substituted for the reference product
				  by a pharmacist without the intervention of the health care provider who
				  prescribed the reference product.
78. "Intern" means a graduate of an
				  Accreditation Council for Pharmaceutical Education (ACPE)-accredited program of
				  pharmacy, or a student enrolled in a professional ACPE-accredited program of
				  pharmacy or a graduate of a foreign college of pharmacy who has obtained full
				  certification from the FPGEC (Foreign Pharmacy Graduate Equivalency Commission)
				  administered by the National Association of Boards of Pharmacy.
79. "Internal test assessment" means, but is
				  not limited to, conducting those tests of quality assurance necessary to ensure
				  the integrity of the test.
80.
				  "Internship" means that period of training of an intern, under the direction of
				  the preceptor, which is required for licensure to engage in the practice of
				  pharmacy.
81. "Investigational
				  drug" means any drug which has not been approved for use in the United States,
				  but for which an investigational drug application has been approved by the Food
				  and Drug Administration (FDA).
82.
				  "ISO" means an air quality classification from the International Organization
				  for Standardization.
83. "Legend
				  drugs" means any drugs that are required by any applicable Federal or State law
				  or Regulation to be dispensed on prescription only or are restricted to use by
				  practitioners only.
84.
				  "Limited-function test" means those tests listed in the Federal Register under
				  the Clinical Laboratory Amendments of 1988 (CLIA) as waived tests.
85. "Live hours" means hours acquired through
				  attendance or participation at programs that provide for direct interaction
				  between faculty and participants and may include lectures, symposia, live
				  teleconferences or workshops.
86.
				  "Low-risk compounded sterile products" means a product compounded with aseptic
				  manipulations entirely within ISO Class 5 or better air quality using no more
				  than three (3) sterile ingredients added to one (1) package.
87. "Manipulations" means aseptically opening
				  ampuls, penetrating sterile stoppers on vials with sterile needles and
				  syringes, and transferring sterile liquids in sterile syringes to sterile
				  administration devices, package containers of other sterile products, and
				  containers for storage and dispensing.
88. "Manufacture" means the production,
				  preparation, propagation, compounding, or processing of a drug or other
				  substance or device or the packaging or repackaging.
89. "Manufacturer" means anyone who is
				  engaged in manufacturing, preparing, propagating, compounding, processing,
				  packaging, repackaging, or labeling of a prescription drug or
				  poisons.
90. "Manufacturing" means
				  the production, preparation, propagation, conversion or processing of a drug or
				  device, either directly or indirectly, by extraction from substances of natural
				  origin or independently by means of chemical or biological synthesis, and
				  includes any packaging or repackaging of the substances or labeling or
				  relabeling of its container, and the promotion and marketing of such drugs and
				  devices. Manufacturing also includes the preparation and promotion of
				  commercially available products from bulk compounds for resale by pharmacists,
				  practitioners, or other persons.
91. "Medical institution" means any hospital,
				  clinic or dispensary.
92.
				  "Medication error" means any preventable event that may cause or lead to
				  inappropriate medication use or patient harm, while the medication is in the
				  control of the healthcare professional, patient, or consumer. Such events may
				  be related to professional practice, healthcare products, procedures, and
				  systems including, but not limited to: prescribing; order communication;
				  product labeling, packaging and nomenclature; compounding; dispensing;
				  distribution; administration; education; monitoring; and use.
93. "Medication administration record" or
				  "MAR" is a report that serves as a record of the drugs administered to a
				  patient at a facility by a health care professional. The MAR is a part of a
				  patient's permanent record on their medical chart.
94. "Medication orders" or "Orders" means a
				  written, verbal or electronically transmitted order for drugs and devices from
				  an authorized practitioner in the State of Rhode Island for the dispensing and
				  administration of a drug.
95.
				  "Medium-risk compounded sterile products" means a product compounded under
				  low-risk conditions with the addition of at least one (1) of the following
				  conditions: compounding a CSP that will be administered to either multiple
				  patients or to one (1) patient on multiple occasions; and the compounding
				  process involves complex aseptic manipulations or an unusually long
				  duration.
96. "Multi-drug
				  single-dosing container" means a container that is a customized single-dosing
				  package labeled by a pharmacy for a specific patient, and such package contains
				  one (1) or more solid, oral dosage form drugs to be administered to or taken by
				  a specific patient at the same dosage time from a single container.
97. "NABP" means National Association of
				  Boards of Pharmacy.
98. "NIOSH"
				  means National Institute for Occupational Safety and Health.
99. "Nonlegend" or "Nonprescription drugs"
				  means any drugs that may be lawfully sold without a prescription.
100. "Nonresident pharmacy" means a pharmacy
				  located outside Rhode Island in any State in the United States or any Province
				  or Territory of Canada that ships, mails, or delivers prescription drugs and/or
				  devices to a patient or person in Rhode Island.
101. "Nuclear pharmacy" means a pharmacy
				  providing radiopharmaceutical services.
102. "Nuclear/radiologic pharmacy practice"
				  refers to a patient-oriented service that embodies the scientific knowledge and
				  professional judgment required to improve and promote health through the
				  assurance of the safe and efficacious use of radiopharmaceuticals and other
				  drugs.
103. "Nursing facility"
				  means a place, however named, or an identifiable unit or distinct part thereof
				  that provides twenty-four (24) hour in-resident nursing, therapeutic,
				  restorative or preventive and supportive nursing care services for two (2) or
				  more residents unrelated by blood or marriage whose condition requires
				  continuous nursing care and supervision.
104. "Outsourcing facility" means a facility
				  at one (1) geographic location or address that is engaged in the compounding of
				  sterile drugs, has elected to register as an outsourcing facility, and complies
				  with all of the requirements of §503B of the Federal Food, Drug, and
				  Cosmetic Act,  21 U.S.C. §
												353b.
105. "Parenteral pharmacy practice" refers to
				  admixtures of sterile parenteral solutions and dispensing of same intended for
				  administration to patients in healthcare facilities and in the home.
106. "Patient profile" means a patient record
				  system that is maintained by all pharmacies for patients for whom prescriptions
				  are dispensed. The patient profile shall provide for the immediate retrieval of
				  information necessary for the dispensing pharmacist to identify previously
				  dispensed drugs at the time a prescription is presented for
				  dispensing.
107. "Patient safety
				  organization" (PSO) means an organization that has as its primary mission
				  continuous quality improvement under the Patient Safety and Quality Improvement
				  Act of 2005 (Pub. Law
				  109-41) and is credentialed by the Agency for
				  Healthcare Research and Quality.
108. "Perforated unit-dose blister packages"
				  means unit-dose containers of a specific medication prepared in multi-dose
				  containers by the manufacturer or pharmacy that includes the identity, quantity
				  and strength of the product, name of the manufacturer, lot number and
				  expiration date and labeled by the pharmacy for a specific patient.
109. "Person" means an individual,
				  corporation, government, subdivision or agency, business trust, estate, trust,
				  partnership or association, or any other legal entity.
110. "Pharmaceutical assistance program (PAP)
				  medication" means a noncontrolled manufacturer-prepared medication that is
				  shipped to a practitioner for a specific "medically indigent" patient,
				  generally defined as those with low income, without insurance, and ineligible
				  for public programs.
111.
				  "Pharmaceutical care" is the provision of drugs and other pharmaceutical
				  services intended to achieve outcomes related to cure or prevention of a
				  disease, elimination or reduction of a patient's symptoms, or arresting or
				  slowing of a disease process. Pharmaceutical care includes the judgment of a
				  pharmacist in dispensing an equivalent and interchangeable drug or device in
				  response to a prescription after appropriate communication with the
				  patient.
112. "Pharmaceutical
				  organization" means any profit or non-profit organization that advocates,
				  lobbies, solicits business, or provides support services to any private or
				  public sector organization, or business within the various disciplines of the
				  pharmacy profession, including but not limited to State pharmacy associations,
				  national pharmacy associations, accrediting organizations and
				  suppliers.
113. "Pharmacist" means
				  an individual licensed to engage in the practice of pharmacy in the State of
				  Rhode Island pursuant to R.I. Gen. Laws §519.1-14.
114. "Pharmacist care services" is the
				  provision by a pharmacist of patient care activities within this State or into
				  this State, as defined by this Part, with or without the Dispensing of Drugs or
				  Devices, 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.
115.
				  "Pharmacist-in-charge" means a pharmacist licensed in the State of Rhode Island
				  designated by the owner as the person responsible for the operation of a
				  pharmacy in conformance with all laws and Regulations pertinent to the practice
				  of pharmacy and who is personally in full and actual charge of such pharmacy
				  and personnel.
116. "Pharmacist
				  with advanced training and experience relevant to the scope of collaborative
				  practice" means, a licensed pharmacist in the State of Rhode Island with
				  post-graduate educational training. Such training shall include, but not be
				  limited to, residency training; board certification; certification from an
				  accredited professional organization educational institution; or any other
				  continuing education provider or employer sponsored training approved by the
				  Director relevant to the proposed scope of the collaborative practice
				  agreement.
117. "Pharmacy" means
				  that portion or part of a premises where prescriptions are compounded and
				  dispensed, including that portion utilized for the storage of prescription or
				  legend drugs.
118. "Pharmacy and
				  therapeutics committee" means the active standing committee in the hospital,
				  nursing or hospice care facility which is the organizational line of
				  communication and liaison between the medical and pharmacy staff which acts to
				  review and promote rational drug therapy and utilization in the licensed
				  facility.
119. "Pharmacy
				  technician" means an individual who meets minimum qualifications established by
				  the Board, that are less than those established by the Act as necessary for
				  licensing as a pharmacist; and who work under the direction and supervision of
				  a licensed pharmacist. There shall be two (2) levels of licensure for Pharmacy
				  Technicians:
a. Pharmacy Technician I;
				  and
b. Pharmacy Technician II. (See
				  also §1.1.10 of this Part). As used in these Regulations, a "Pharmacy
				  Technician II" is one who is licensed by the Board as a Pharmacy Technician and
				  who is also currently certified by the Pharmacy Technician Certification Board
				  (PTCB) of the American Pharmacists' Association or other national certifying
				  organization as may be approved by the Board.
120. "Practice of pharmacy" means the
				  interpretation, evaluation and implementation of medical orders; the dispensing
				  of prescription drug orders; participation in drug and device selection; drug
				  regimen reviews and drug or drug related research as well as medication therapy
				  management (MTM); the participation in collaborative practice; the
				  administration of medications; the administration of immunizations pursuant to
				  a valid prescription or prescriber-approved protocol and in accordance with
				  Regulations, to include training requirements, as promulgated by the
				  Department; provision of patient counseling and the provision of those acts or
				  services necessary to provide pharmaceutical care; and the responsibility for
				  the supervision for compounding and labeling of drugs and devices (except
				  labeling by a manufacturer, repackager, or distributor of non-prescription
				  drugs and commercially packaged legend drugs and devices) proper and safe
				  storage of drugs and devices; and maintenance of proper records for them and
				  the performance of clinical laboratory tests provided such testing is limited
				  to limited-function tests as defined in this Part. Nothing in this definition
				  shall be construed to limit or otherwise affect the scope of practice of any
				  other profession.
121.
				  "Practitioner" means a physician, physician assistant, dentist, veterinarian,
				  nurse or other person duly authorized by law in the State in which he/she
				  practices to prescribe drugs.
122.
				  "Preceptor" means a pharmacist licensed to engage in the practice of pharmacy
				  in the State of Rhode Island or a licensed pharmacist in the USA who has the
				  responsibility for training interns.
123. "Prescription" means an order for drugs
				  or devices issued by the practitioner duly authorized by law in the State in
				  which he/she practices to prescribe drugs or devices in the course of his/her
				  professional practice for a legitimate medical purpose.
124. "Prescription sample" means a
				  complimentary drug packaged in accordance with federal and state statutes and
				  provided to a licensed practitioner free of charge by manufacturers.
125. "Prescription drug" or "Legend drug"
				  means a drug which, under Federal law, is required, prior to being dispensed or
				  delivered, to be labeled with either of the following statements:
a. "Rx only";
b. "Caution: Federal law restricts this drug
				  to use by, or on the order of, a licensed veterinarian"; or
c. A drug which is required by any applicable
				  Federal or State law or Rule to be dispensed pursuant only to a prescription,
				  or is restricted to use by practitioners only, and includes finished dosage
				  forms and active ingredients subject to §503(b) of the Federal Food, Drug,
				  and Cosmetic Act, including all medical gases.
126. "Product liability", as used herein,
				  means insurance coverage protecting the Canadian pharmacy against legal
				  liability resulting from a defective condition causing bodily injury, or
				  damage, to any individual or entity, associated with the use of the
				  product.
127. "Prospective drug
				  review" means a review of the patient's drug therapy record and prescription,
				  as established in the rules of the Board, prior to dispensing the drug as part
				  of a drug regimen review.
128.
				  "PTCB" means Pharmacy Technician Certification Board.
129. "Qualified licensed professional" means
				  a non-pharmacist individual (such as physician, nurse, physician assistant or
				  technologist) who possesses a current State license, if applicable, and who has
				  sufficient training and experience to safely handle and dispense
				  radiopharmaceuticals as defined by the respective requirements of the Rhode
				  Island Rules and Regulations for the Control of Radiation Healthcare,
				  Subchapter 20 of this Chapter and R.I. Gen. Laws Chapter
				  23-1.3.
130. "Qualified nuclear pharmacist" means a
				  currently licensed pharmacist in the state of Rhode Island, who is identified
				  as an Authorized Nuclear Pharmacist on a radioactive materials license issued
				  pursuant to Subpart C.8 of the "Rules and Regulations for the Control of
				  Radiation [R
				  23-1.3 -RAD]" or equivalent
				  Regulations of the U.S. Nuclear Regulatory Commission or another Agreement
				  State.
131. "Reasonable effort"
				  includes collecting patient information with printed data forms provided to the
				  patient by the pharmacist, the pharmacist interviewing the patient to develop a
				  patient's medication history, or similar patient-pharmacist interactions where
				  the pharmacist assumes responsibility to collect, record, and maintain
				  information necessary to properly dispense a prescription and counsel a
				  patient. Collection of patient information may be appropriately delegated by
				  the responsible pharmacist.
132.
				  "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 their suitability for use in humans and animals, including internal
				  test assessment, authentication of product history and the keeping of proper
				  records.
133.
				  "Radiopharmaceuticals" are radioactive drugs as defined by the FDA and
				  regulated pursuant to R.I. Gen. Laws Chapter
				  23-1.3 and the "Rules and
				  Regulations for the Control of Radiation [R
				  23-1.3 -RAD]."
134. "Radiopharmaceutical service" means, but
				  is not limited to, the procurement, storage, handling, preparation, labeling,
				  quality assurance testing, dispensing, delivery, record keeping, and disposal
				  of radiopharmaceuticals and other drugs.
135. "Recognized provider" means any person,
				  corporation or association approved either by the Board, the Accreditation
				  Council for Pharmaceutical Education (ACPE), or American Medical Association
				  (AMA) Category I Programs, to conduct continuing education programs.
136. "Restricted pharmacy" is a facility
				  established pursuant to R.I. Gen. Laws §
											5-19.1-10, and the provisions of
				  the Employee Retirement Income Security Act of 1974,
				   29 U.S.C. §
												1001
et seq
., for the
				  purposes of dispensing drugs to the beneficiaries of any trust, fund, pension
				  plan, combination plan, or profit sharing plan.
137. "Retail pharmacy" means any pharmacy
				  where drugs are compounded, dispensed, stored or sold or where prescriptions
				  are filled or dispensed to the general public.
138. "Retrospective drug review" means the
				  monitoring for therapeutic appropriateness, over-utilization and
				  under-utilization, appropriate use of generic products, therapeutic
				  duplication, drug-disease contraindications, drug-drug interactions, incorrect
				  dosage or duration of drug treatment, and clinical abuse/misuse after the drug
				  has been dispensed.
139. "Shared
				  order filling" means that the functions of: preparation, packaging,
				  compounding, or labeling of an order or any combination of these functions by
				  an authorized person located at a pharmacy on behalf of and at the request of
				  another pharmacy; and returning the filled order to the requesting pharmacy for
				  delivery to the patient or patient's agent or, at the request of the delivery
				  pharmacy, directly delivering the filled order to the patient, or an alternate
				  location of the patient's choosing.
140. "Shared order processing" means that the
				  functions of: interpreting and entering the order, performing drug utilization
				  reviews, refill authorizations, or therapeutic interventions, or any
				  combination of these functions are performed in accordance with the Act and
				  these Regulations, and are performed at a licensed pharmacy at the request of,
				  and on behalf of, another pharmacy.
141. "Shared pharmacy services" means a
				  system that allows a participating pharmacist or pharmacy pursuant to a request
				  from another participating pharmacist or pharmacy to process or fill a
				  Prescription Drug Order, which may include preparing, packaging, labeling,
				  compounding for specific patients, dispensing, performing Drug Utilization
				  Reviews, reviewing therapeutic interventions, and/or reviewing institutional
				  facility orders.
142. "Shared
				  services pharmacy" means both central fill and delivery pharmacies that have
				  the same owner, or have a written contract outlining the services provided and
				  the shared responsibilities of each party in accordance with the Act and this
				  Part, and that participate in shared order filling or shared order processing,
				  or both.
143. "Sterile compounding"
				  means any manipulation of a sterile or non-sterile product intended to produce
				  a sterile final product.
144.
				  "Standing order" means a prewritten medication, medical supply(ies) or
				  equipment order with specific instructions from a licensed independent
				  practitioner to administer, prescribe or dispense a medication, supplies, or
				  equipment to a person in clearly defined circumstances.
145. "Substance abuse facility" means a
				  facility licensed by the State Department of Behavioral Healthcare,
				  Developmental Disabilities and Hospitals that includes residential treatment
				  services and detoxification services.
146. "Supply" means the delivery of a
				  non-controlled medication to a patient by a practitioner by one (1) of the
				  following methods and in accordance with the requirements stated herein:
a. Pre-packaged prescription sample
				  medication;
b. Automated dispensing
				  system;
c. Administration of a
				  stock medication;
d. Dispensing of
				  a manufacturer-prepared pap medication;
e. Dispensing of oral and transdermal
				  contraceptives.
147.
				  "Unit-dose container" is one that is designed to hold a quantity of drug
				  intended for use as a single dose and used promptly after the container is
				  opened. The immediate container, and/or the outer container or protective
				  packaging shall be designed to show evidence of any tampering with the
				  contents. Each individual container shall be fully identifiable containing a
				  single dose of a single entity and shall protect the integrity of the dosage
				  form. Labeling shall be in accordance with USP standards compendia and Federal
				  and State law and shall include the identity, quantity, and strength of the
				  product, name of the manufacturer, and lot number and expiration date of the
				  article.
148. "USP" means the
				  United States Pharmacopeia.
149.
				  "Wholesale distribution" means distribution of prescription drugs to person
				  other than a consumer or patient, but does not include:
a. Intracompany sales;
b. The purchase or other acquisition by a
				  hospital or other healthcare entity that is a member of a group purchasing
				  organization of a drug for its own use from the group purchasing organization
				  or from other hospitals or healthcare entities that are members of such
				  organizations;
c. The sale,
				  purchase or trade of a drug of an offer to sell, purchase, or trade a drug by a
				  charitable organization to a non-profit affiliate of the organization to the
				  extent otherwise permitted by law;
d. The sale, purchase, or trade of a drug or
				  an offer to sell, purchase, or trade a drug among hospitals or other healthcare
				  entities that are under common control. For purposes of this section, "common
				  control" means the power to direct or cause the direction of the management and
				  policies of a person or an organization, whether by ownership of stock, voting
				  rights, by contract or otherwise;
e. The sale, purchase or trade of a drug or
				  an offer to sell, purchase, or trade a drug for emergency medical reasons. For
				  purposes of this section, "emergency medical reasons" includes transfers of
				  prescription drugs by a retail pharmacy to another retail pharmacy to alleviate
				  a temporary shortage;
f. The sale,
				  purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or
				  the dispensing of a drug pursuant to a prescription;
g. The lawful distribution of drug samples by
				  manufacturers' representatives or distributors' representatives;
h. The sale, purchase, or trade of blood and
				  blood components intended for transfusion;
i. Every hospital licensed in accordance with
				  R.I. Gen. Laws Chapter
				  23-17 that is required to restock
				  supplies listed by the Director of Health that are used by a licensed emergency
				  medical services provider in transporting emergency patients to such hospital,
				  pursuant t o R.I. Gen. Laws §
												23-4.1-7.1.
j. Every hospital licensed in accordance with
				  R.I. Gen. Laws Chapter
				  23-17 that accepts vaccine from
				  the Department and distributes such vaccine as part of the Department's
				  immunization program.
150. "Wholesale distributor" means anyone
				  engaged in wholesale distribution of drugs, including, but not limited to,
				  manufacturers, repackers, own-label distributors, private-label distributors,
				  jobbers, brokers, warehouses, including manufacturers' and distributors'
				  warehouses, chain drug warehouses, and wholesale drug warehouses, independent
				  wholesale drug traders, and retail pharmacies that conduct wholesale
				  distribution.
151. "Wholesaler"
				  means a person who buys drugs or devices for resale and distribution to
				  corporations, individuals, or entities other than consumers.