216-40-15 R.I. Code R. § 1.4

Current through June 20, 2024

Section 216-RICR-40-15-1.4 - Pharmacists/Licensure Requirements

1.4.1Licensure Requirements

A. No person, unless a licensed pharmacist shall retail, compound or dispense drugs, medicine or poisons, except as provided pursuant to statutory provisions of R.I. Gen. Laws § 5-19.1-8.

B. The Director has determined that, in the interest of public health, a waiver of the requirements of §1.4.1 of this Part is necessary under limited circumstances. Specifically, the waiver shall only be applicable when such medication will be dispensed by a licensed healthcare professional at the Block Island Health Center or, in the event that the Block Island Health Center ceases to exist, to another pharmacy licensed in the Town of New Shoreham, Rhode Island, and it is necessary to dispense medication before the medication can be delivered to the island. The waiver shall be subject to the following provisions:

1. Medication to be dispensed shall be limited to legend drugs included in a written policy established by the Block Island Health Center. A full instruction on the use of the product in plain language shall be provided to the patient.

2. The Block Island Health Center shall keep a written log of all medications dispensed pursuant to the waiver authorized by this Part. The dispensing log shall contain, as a minimum, the following information:

a. The name of the prescriber;

b. The full name of the patient;

c. The name of the drug dispensed in accordance with R.I. Gen. Laws Chapter 21-31;

d. Quantity and strength of the drug dispensed; and

e. The date of dispensing.

3. Copies of the dispensing logs shall be maintained for twenty-four (24) months from the date the legend drug was dispensed and shall be made available to the Department upon request.

4. Each medication dispensed pursuant to the waiver authorized by this Part shall have a label attached which meets the requirements of §1.5.17(A) of this Part.

5. When required, the healthcare provider who dispenses medication pursuant to the waiver authorized by §1.4.1 of this Part shall be responsible for ensuring that all necessary data is entered into the Department's Prescription Monitoring Program (PMP) database in accordance with the Rules and Regulations for the Prescription Drug Monitoring Program (Part 20-20-3 of this Title).

6. Any waiver utilized pursuant to this Part shall not relieve the licensed healthcare provider of record-keeping or other requirements of this Part.

1.4.2Authorized Practices

A. In accordance with R.I. Gen. Laws § 5-19.1-22, nothing in the Act or this Part shall apply to any practitioner with authority to prescribe who does not maintain an open shop for the retailing, dispensing of medicines and poisons, nor prevent him or her from administering or supplying to his patients such articles as he/she may deem fit and proper.

B. Nothing in the Act or this Part shall apply to, nor in any manner interfere with the business of, a general merchant in selling and distributing non-narcotic, nonprescription medicines or drugs which are prepackaged, fully prepared by the manufacturer for use by the consumer, and labeled in accordance with the requirements of the State (R.I. Gen. Laws Chapter 21-31) and Federal Food and Drug Acts.

1.4.3Qualifications for Licensure: Pharmacists

A. In addition to the provisions of R.I. Gen. Laws § 5-19.1-14, every person in order to be a licensed pharmacist shall:

1. If the applicant is a foreign pharmacy graduate, have obtained full certification from the FPGEC.

2. Have satisfactorily completed the internship in accordance with §1.4.14 of this Part; and

3. Have successfully passed such examination as the Board and the Director may require in accordance with §1.4.5(A) of this Part.

4. Not have been convicted of any felony for violations involving controlled substances subject to waiver by the Board upon presentation of satisfactory evidence that such conviction does not impair the ability of the person to conduct with safety to the public the practice of pharmacy.

5. Obtain and report an eProfile number from NABP.

6. Meet such additional requirements as may be established in this Part.

1.4.4Application for Licensure and Fee

A. Application for licensure shall be made on forms provided by the Department, and which may be obtained at:

The Rhode Island Department of Health

Three Capitol Hill, Room 103

Providence, Rhode Island 02908

1. Said forms shall be completed and signed by the applicant, and submitted to the Department no sooner than thirty (30) days prior to the scheduled date of graduation. Such application shall be accompanied by the following documents and fee (non-returnable):

a. A true copy of certificate of birth;

b. One (1) unmounted recent photograph, head and shoulders, front view, approximately two inches by three inches (2" x 3") in size, of the applicant. Such photograph must be certified by a member of the faculty of the college of pharmacy at which the applicant matriculated;

c. Proof of graduation from an accredited College of Pharmacy;

d. The application fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).

B. Application and supporting documents shall be verified and reviewed by the Department. Eligibility for examinations shall not be granted until after the applicant's date of graduation.

C. No applicant shall be approved or accepted for examination until he/she has met all requirements of internship as set forth in §1.4.14 of this Part. Affidavit of internship hours shall be submitted to the Department prior to application for licensure.

D. Applications shall be completed (including the submission of all supporting documents) within six (6) months of the date of initial submission. Any application that is not completed within this six (6) month time frame shall be deemed to be invalid, shall be denied, and the applicant shall be required to submit a new application. No fees shall be refunded.

1.4.5Examination for Licensure

A. By Examination: Applicants shall be required to pass a written examination, conducted in English, as the Board deems most practical and expeditious to test the applicant's knowledge and skills to engage in the practice of pharmacy in the State of Rhode Island, pursuant to R.I. Gen. Laws § 5-19.1-14.

1. For written examination the Board requires applicants to successfully pass the following examinations:

a. The North American Pharmacists Licensure Examination (NAPLEX) or its successor examination of the National Association of Boards of Pharmacy (NABP) which may be:

(1) Administered in the State of Rhode Island with the passing grade as determined by NABP and approved by the Board; or

(2) Administered in another State by the licensing authority of the respective State, and provided the requirements of §1.4.5(B) of this Part on transfer of grades are met; and

b. The Multistate Pharmacy Jurisprudence Examination (MPJE) with a passing grade as determined by NABP.

B. Transfer of Grades

1. Applicants wishing to participate in the National Association of Boards of Pharmacy Transfer of Scores Program must comply with all the requirements of the National Association of Boards of Pharmacy regarding the transfer of scores including but not limited to the submission to the National Association of Boards of Pharmacy the completed and signed NAPLEX SCORE TRANSFER FORM with accompanying fee (non-refundable).

2. For individuals seeking licensure in Rhode Island, the Board of Pharmacy will only accept scores submitted directly by the National Association of Boards of Pharmacy. Furthermore, each individual seeking licensure in the State of Rhode Island must submit an application for licensure to the Department in accordance with §1.4.12 of this Part and must meet all other statutory and regulatory requirements in this Part.

3. Applicants participating in the Transfer of Scores Program shall complete the Multistate Jurisprudence Examination, as described in §1.4.5(A) of this Part, within six (6) months of application to the Rhode Island Board of Pharmacy.

1.4.6Re-Examination

A. In case of failure of any applicant to satisfactorily pass the NAPLEX Examination, and/or the Multistate Pharmacy Jurisprudence Examination (MPJE), such applicant shall be entitled to re-examination(s) in accordance with NABP guidelines.

B. Application for re-examination shall be submitted to the Department and accompanied by the required fees in accordance with §1.4.4 of this Part.

1.4.7Without Examination by Reciprocity

A. The Department shall, without examination other than those required in §1.4.5 of this Part relating to the practice of pharmacy, license as a pharmacist any individual who has been duly licensed by examination as a pharmacist under the laws of another State, Territory or Possession of the United States, if, in the opinion of the Board, the applicant meets the qualifications required of professional pharmacists in the State of Rhode Island.

1. The Board of Pharmacy in each State in which the applicant holds or has held a registration or license submits to the Board in the State of Rhode Island a statement confirming the applicant to be or have been in good standing.

2. The applicant shall have passed the Multistate Pharmacy Jurisprudence Examination and the examination of the National Association of Boards of Pharmacy in accordance with the provisions of §1.4.5 of this Part.

3. The applicant shall submit to the Department the Official Transfer of Pharmaceutic Licensure Application of the NABP, a copy of his/her birth certificate, and the application fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).

1.4.8Temporary Ninety (90) Day License

A. In accordance with R.I. Gen. Laws § 5-19.1-8 persons who provide acceptable evidence of being currently licensed by examination or endorsement under the laws of other States of the United States and the District of Columbia, shall not be prevented from practicing in the State of Rhode Island for a period of ninety (90) days from the date on the application receipt, provided that they become duly licensed in the State of Rhode Island within ninety (90) days. This original privilege to work ninety (90) days shall not be extended or renewed and shall only be granted to an applicant on a one (1) time basis.

B. The licensing agency in each State in which the applicant holds or has held a registration or license shall submit to the Board a statement confirming the applicant to be or have been in good standing in that state.

1.4.9Internship: Pharmacy Interns

A. General Requirements

1. Any person who is a graduate of an accredited program of pharmacy or who is a student enrolled in an accredited program of pharmacy, or any graduate of a foreign College of Pharmacy who has obtained FPGEC certification, may file with the Department an application for licensure as a pharmacy intern. He/she shall be required to furnish such information as the Department may prescribe and, simultaneously with the filing of said application, shall pay to the Department a fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).

2. All licenses issued to pharmacy interns shall be valid for a period of one (1) year, but in no instance shall the license be valid if the individual is no longer making timely progress toward graduation.

3. No pharmacy student may serve an internship with a preceptor without holding a valid limited license from the Board.

4. To assure adequate practical instruction, pharmacy internship experience as required under the Act and this Part shall be obtained after licensure as a pharmacy intern by practice in any licensed pharmacy or other program meeting the requirements promulgated in this Part, and shall include such instruction in the practice of pharmacy as the Board shall prescribe.

5. Licensed pharmacy interns shall practice only under the immediate supervision of a licensed pharmacist.

1.4.10Limited License

A. No pharmacy student enrolled in a professional program of an accredited college of pharmacy may serve an internship in the State of Rhode Island with a preceptor without holding a valid limited license by the Board of Pharmacy pursuant to the provisions of R.I. Gen. Laws § 5-19.1-15.

B. Prior to commencing internship, the applicant must obtain a limited license from the Department. A limited license shall be granted to an applicant who:

1. Is eighteen (18) years of age or older;

2. Has satisfied the board that he/she is of good moral and professional character;

3. Is enrolled in a professional program of an accredited College of Pharmacy.

1.4.11Foreign Graduates

Foreign graduates shall have obtained full FPGEC certification prior to commencing internship.

1.4.12Application and Fee

A. Application for limited licensure shall be made on forms provided by the Department and which may be obtained at:

The Rhode Island Department of Health

Three Capitol Hill, Room 103

Providence, Rhode Island 02908

1. Said forms shall be completed and signed by the applicant and submitted to the Department prior to accruing any hours. Such application shall be accompanied by the following documents and fee (non-returnable and non-refundable):

a. A copy of certificate of birth to verify that the applicant is eighteen (18) years of age or older;

b. Documented evidence that the student is enrolled in a professional program of an accredited college of pharmacy, and signed by the Dean of the College of Pharmacy or his appointed designee;

c. The application fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).

2. Foreign Interns: The license application requirement of a documented Social Security Number (SSN) may only be waived for the initial license year. Subsequent license renewal shall require a documented SSN. A foreign pharmacy intern may practice under a limited license without a registered SSN at the discretion of the preceptor.

1.4.13Issuance of Limited License

A. The application and credentials of the applicant shall be reviewed and verified by the Department. Applicants found to meet the requirements herein shall be issued a limited license. Said license unless sooner suspended or discontinued for due cause in accordance with §1.4.2 of this Part, shall expire annually on the first (1^st) day of July. Said license may be renewed annually, subject to the applicant meeting the requirements herein, and upon submission of the annual license fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).

B. A limited license is not transferable.

C. Every graduate of an approved School of Pharmacy functioning as a pharmacy intern who has filed with the Board a completed application, with supporting documents of credentials, for licensure as a pharmacist, may upon receiving a receipt from the Board for said application and documents, function as a pharmacy intern, until such time as a license is received from the Department, and for no more than one (1) year from the date of graduation from an ACPE-accredited College of Pharmacy, and in each case he/she shall be supervised by a registered pharmacist licensed in the State of Rhode Island.

1.4.14Internship

A. The internship required of applicants for licensure as pharmacists shall consist of one thousand five hundred (1,500) hours, and shall be carried out under the supervision of a U.S. registered or licensed pharmacist who shall act as a preceptor.

B. Applicants seeking licensure as a pharmacist by reciprocity (§1.4.6 of this Part) shall have satisfied the requirements of internship in the State of initial licensure.

C. Prior to application for examination, the pharmacy intern shall submit, on forms provided by the Department, verification of his/her practical experience under the supervision of a licensed pharmacist. Any hours accrued prior to the issuance of the limited license shall not be accepted as part of the internship requirement.

1.4.15Duties and Responsibilities of Pharmacy Interns

A. Pharmacy interns may perform only those tasks in which they have proficiency, in the professional judgment of the pharmacist-in-charge, but in no case shall ever exceed what is permitted by Regulation or law.

B. A pharmacy intern may not perform a final review or exercise final decision-making with respect to any of the following without the prior review and approval of the licensed pharmacist: drug utilization review; clinical conflict resolution, or dispensing process validation.

C. A pharmacy intern shall wear a name tag that indicates the intern's name and the intern's licensure designation.

1.4.16Issuance and Renewal of the Pharmacist License

A. Upon completion of the aforementioned requirements, a license shall be issued by the Department to an applicant found to have satisfactorily met all the requirements herein. Said license shall expire on the thirtieth (30^th) of June each year unless sooner suspended or discontinued.

B. Every person licensed as a pharmacist in the State of Rhode Island who desires to renew his/her license shall file such renewal application with the Department by the thirtieth (30^th) day of June each year. Said renewal shall be duly executed together with the renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).

1. Upon receipt of such application and payment of such fee, the accuracy of the application shall be verified and a license renewal shall be granted effective for up to two (2) years unless sooner suspended or discontinued.

C. Every person licensed as a pharmacist in this State who desires to renew his/her license must obtain an eProfile number from the national association of boards of pharmacy.

D. Any person who allows his/her license to lapse by failing to renew it on or before the thirtieth (30^th) day of June of each year may be reinstated upon filing an application with payment of the renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).

1. Any pharmacist license that has lapsed, been revoked or suspended and the pharmacist has not practiced pharmacy, as defined by the Board, for three (3) years requires that he/she take and pass the same examinations required for initial licensure.

1.4.17Continuing Education

A. Pursuant to the provisions of R.I. Gen. Laws § 5-19.1-14, any pharmacist, licensed to practice pharmacy in Rhode Island, who seeks licensure renewal, shall be required to have satisfactorily completed at least fifteen (15) hours (one and a half (1.5) continuing education units) of continuing education courses sponsored by a recognized provider between January 1^st and December 31^st of each calendar year. One (1) hour or one tenth (0.1) continuing education units of the required fifteen (15) hours of continuing education between January 1^st and December 31^st of each calendar year shall be in the area of the law as classified by ACPE. Furthermore, five (5) hours or one half (0.5) continuing education units between January 1^st and December 31^st of each calendar year must be live hours. In addition:

1. Immunizing pharmacists shall complete one (1) hour or one tenth (0.1) continuing education units of the required fifteen (15) hours of continuing education.

2. Any pharmacist participating in a collaborative pharmacy practice agreement shall earn at least five (5) additional contact hours or one half (0.5) continuing education units of board-approved continuing education that addresses areas of practice generally related to collaborative practice agreements each year and shall maintain documentation of these hours at the practice site to be made available for inspection by the Boards of Medical Licensure and Discipline and Pharmacy.

3. Any pharmacist who has not participated in a collaborative pharmacy practice arrangement for a period of two (2) years and seeks to enter into such an arrangement, must have obtained and/or maintained the certification set forth in this Part, as applicable, or have earned fifteen (15) hours of relevant continuing education within the prior year in the area of practice covered by the agreement.

4. A pharmacist shall not be subject to the continuing education requirements of this Part in the year that he/she graduated, with the exception of the continuing education requirement contained in §1.11.1(B)(7) of this Part; and

5. In emergency or hardship cases, a licensed pharmacist may apply to the Board on forms provided by the Department for an exemption from the continuing education requirements of this Part.

6. The annual application for license renewal shall include affidavits signed by the applicant attesting to the fact that he/she has satisfactorily completed an approved course(s) of continuing education provided by a recognized provider, as defined in this Part. Furthermore:

a. Certificates of continuing education courses must be retained and safeguarded by each pharmacist for review by the Department, if required and requested. Such certificate need not be submitted with the application for licensure renewal; however, documentation must be retained for two (2) years following the date of completion of the course.

b. Any pharmacist whose license has not been renewed for one (1) or more years must demonstrate compliance with continuing education Regulations for the licensure period immediately prior to application.

c. Pharmacists failing to comply with the requirements of §1.4.17(A)(6) of this Part.

1.4.18Recognized Provider

A "recognized provider" is any person, group or organization approved by the Board as responsible and competent to provide continuing education courses and includes providers accredited by an appropriate national, regional or state accreditation agency. Any provider approved the Accreditation Council for Pharmaceutical Education (ACPE), the Board of Pharmacy in another State or jurisdiction, or the provider of American Medical Association (AMA) Category I programs shall be considered recognized providers.

1.4.19Continuing Education Credit for Postgraduate Pharmacy Curriculum/Program

A. A licensed pharmacist who is enrolled in a postgraduate Doctor of Pharmacy program shall be awarded CEUs for satisfactory completion of courses within said curriculum or program, provided that the sponsor of the postgraduate curriculum or program is an accredited College of Pharmacy. A licensed pharmacist enrolled in other postgraduate pharmacy programs may seek continuing education credit provided that the application satisfies all requirements under this section and provided further that the course provides instruction in one (1) or more of the following areas: pharmacy, pharmaceutical sciences, pharmacy practice or pharmacy law.

B. Students seeking continuing education credit for postgraduate pharmacy education must maintain official course transcripts for two (2) years after completion of the course work.

1.4.20Return or Exchange of Drugs

A. Drugs, medicines, sick room supplies, and items for personal hygiene, shall not be accepted for return or exchange by any pharmacist, after such drugs, medicines, sick room supplies, or items for personal hygiene have been taken from the premises where sold, distributed, or dispensed, except under the following conditions:

1. Recalls or Errors. Prescription drugs may be returned in the event the drug is subject to a manufacturer's recall or FDA recall, or if the drug is associated with a medication error.

2. Prescription Drugs. Unused prescription drugs may be accepted by wholesalers or pharmacies, from which they were purchased, for return from nursing facilities, assisted living residences, residential care facilities, community health organizations and State correctional facilities that centrally store prescription drugs and are licensed at the M1 licensure level by the Department, within forty-five (45) days of dispensing.

a. The wholesaler or pharmacy to which the following categories of prescription drugs are returned may repackage, restock, and redistribute such medication:

(1) Unopened sections of blister pack prescription medication, with seal intact;

(2) Unopened unit-dose containers of liquids with the safety seal intact;

(3) Unopened unit-dose containers of powders for oral solution with safety seal intact; and

(4) Unused injectables, with safety seal intact.

b. Exceptions. Notwithstanding the provisions of §1.4.20(B)(1) of this Part, the unused prescription drug shall not be accepted, repackaged or redispensed if:

(1) The prescription drug is expired or beyond use date;

(2) The pharmacist accepting or redispensing the drug, in his/her judgment has reason to believe that the prescription drug is adulterated, mislabeled, or has been improperly stored;

(3) The prescription drug is defined as controlled substances in R.I. Gen. Laws § 21-28-1.02; or

(4) It is a drug that can only be dispensed to a patient registered with the drug's manufacturer in accordance with Federal Food and Drug Administration requirements.

3. Recording: The wholesaler or pharmacy shall maintain a record of the receipt of each drug, medicine, or device showing the prescription number for which the material was acquired, and quantity. Such records shall be kept on file in the pharmacy for a period of two (2) years and shall be made available to the Department upon request.

4. The wholesaler or pharmacy shall be required to reimburse or credit the purchaser for any such returned prescription drugs at original invoice price plus a restocking fee not to exceed five dollars ($5.00).

5. Sick Room Supplies/Equipment: A pharmacist may accept for return sick room supplies/equipment provided such can be sanitized. If the surfaces of the sick room supplies or equipment cannot be cleansed or sterilized, the articles are not returnable. However, sick room supplies are not to be construed to mean nor include hospital beds, wheel chairs, crutches and such other major equipment used in the care and treatment of the sick and injured.

1.4.21Multi-Drug Single-Dosing Systems

A. General Requirements

1. Requirements related to the utilization of multi-drug single-dosing containers include the following:

a. The number of drugs placed in one package cannot exceed the capacity of the container in order to prevent damage to the individual dosage forms;

b. The multi-drug single-dosing container may include controlled medications from Schedule IV and V if such medications are prescribed for the patient on a routine, customary basis;

c. The labels must be of sufficient size to properly and clearly label each container with all information required by State and Federal law and Rules

d. The integrity of each individual multi-drug single-dosing container shall be maintained until the last drug dose is administered to or taken by the patient.

2. A multi-drug single-dosing container shall be designed to prevent the container from being re-closed, designed to show evidence of having been opened, and designed in such a manner that the label cannot be altered.

3. Once a multi-drug single-dosing container has been properly labeled and dispensed to a patient, and said container is returned to the pharmacy for any reason, the drugs packaged in such container shall be considered adulterated and shall not be returned to the pharmacy stock. Provided, however, drugs in multi-drug single-dosing containers may be redispensed to the same patient to whom the drugs were originally dispensed.

4. Whenever a drug(s) in a multi-drug single-dosing container has/have been discontinued, the remaining container(s) may be returned to the dispensing pharmacy for the removal of the discontinued drug(s) for destruction. Under no circumstances shall any of the remaining or discontinued drug(s) be returned to the drug stock of the pharmacy or dispensed to any patient other than the patient to whom the drugs were originally dispensed.

5. Nothing contained in this Part is meant to prevent a nurse or a patient-specified caregiver from removing a discontinued drug(s) from a container at the time of administration in order to be wasted as directed by a pharmacist or from retaining up to a seventy-two (72) hour supply of the continued drug(s) in the original container in order to maintain a patient on his/her continuing drug administration schedule.

B. Labeling Requirements

1. Each individual, customized, multi-drug single-dosing container shall bear a label, which, at a minimum, contains the following:

a. The name of the patient;

b. The name of the prescribing practitioner of each drug;

c. The identifying serial number assigned to the prescription drug order for each drug contained therein;

d. The name, strength, exact physical description, and total quantity of each drug contained therein;

e. The directions for use, and/or time of administration or time to be taken for each individual multi-drug single-dosing container;

f. Either the dispensing or preparation date, as well as a beyond-use (expiration) date for each drug contained in the multi-drug singledosing container. The expiration date of each drug included therein shall not be longer than one (1) year from the date of preparation of the multi-drug single-dosing container. All drugs shall be packaged in accordance with USP standards.

2. The name, address, and telephone number of the pharmacy issuing the multi-drug single dosing container and any cautionary statements necessary for the proper administration or storage of the medication shall appear on the individualized patient container.

C. Exclusions. Multi-drug single-dosing containers shall not include drug(s) that have the following characteristics:

1. USP-DI monograph or official labeling requires dispensing in the original container;

2. Are incompatible with packaging components or with each other;

3. Require special packaging;

4. Are controlled medications from Schedules II and III.

D. Requirements for Nursing Facilities and Assisted Living Residences

1. Requirements related to the utilization of multi-drug single-dosing containers in a nursing facility or assisted living residence include the following:

a. The name, address, and telephone number of the pharmacy issuing the multi-drug single dosing container and any cautionary statements necessary for the proper administration or storage of the medication shall appear on the medication administration record (MAR).

2. In a nursing facility or assisted living residence licensed at the M-1 level, only a nurse, other licensed person acting within his/her scope of practice, or selected non-licensed personnel who have satisfactorily completed a State-Approved Course in Drug Administration and have demonstrated competency in accordance with the State-approved protocol in drug administration shall remove a discontinued drug(s) from a container in order to be wasted in accordance with policies and procedures of the facility.

E. Prescriptions. A prescription shall contain the following information, at a minimum:

1. Full name and street address of the patient;

2. Name, address, and if required by law or Rules of the Board, DEA registration number of the prescribing practitioner;

3. Date of issuance;

4. Name, strength, dosage form and quantity of drug prescribed;

5. Directions for use;

6. Refills authorized, if any;

7. If a written prescription, prescribing practitioner's signature;

8. If an electronically transmitted prescription, prescribing practitioner's electronic or digital signature;

9. If a hard copy prescription is generated from a facsimile or a prescribing practitioner's electronic or manual signature, such prescription shall be applied to paper that utilizes features that will ensure the prescription is not subject to any form of copying and/or alteration;

10. Oral prescriptions shall be reduced promptly to writing and stored either electronically or in hard copy format.

1.4.22Prescription Refill Information

A. No pharmacist shall fill or refill any prescription after one (1) year from the date of issuance by the practitioner without authorization from the practitioner.

B. Authorization for prescription refills is presumed to be within the prescribed dosage or normal therapeutic use. Refiling prescriptions more frequently than the prescribed dosage would require, or refiling prescriptions in significant excess of normal therapeutic use, may constitute unprofessional conduct based on drug utilization requirements in § 1.16 of this Part.

C. If deemed appropriate in the pharmacist's professional judgement, a patient may receive, upon request, drug quantities in excess of the face amount written on the prescription for a non-controlled substance only, up to the total amount authorized by refills. The pharmacist shall not dispense in excess of the face amount of a prescription for controlled substance without authorization from the prescriber for each prescription.

D. A pharmacist may refill a prescription for a patient written by a practitioner who has expired or has had his/her license to practice or controlled substance registration revoked, suspended, or discontinued, for a period not to exceed ninety (90) days, if the prescription was written by the practitioner prior to his/her death or action against license and the prescription contains authorizations for refills.

E. Pharmacists shall only compound prescriptions for a drug product(s) not included in the official compendium (The U.S. Pharmacopoeia, N.F.) if the prescription clearly delineates in writing all the ingredients to be included in the drug product. All such prescriptions, drugs and ingredients must conform to the requirements of R.I. Gen. Laws Chapters 21-31, 21-28, 5-19.1 and such other applicable statutory requirements.

1.4.23Electronic Transmission

A. Technological devices for the transmission or communication of prescriptions between licensed prescribers and pharmacists may be used in accordance with the following requirements:

1. The transmission of prescriptions for controlled substances shall comply with the provisions of R.I. Gen. Laws Chapters 21-28 ("Controlled Substances Act"), 21 C.F.R. § 1306.08, R.I. Gen. Laws Chapter 5-37.3 ("Confidentiality of Healthcare Information Act"), and all other Federal or State laws.

2. Unless otherwise prohibited by law, prescriptions may be transmitted by electronic means or facsimile from the prescriber as defined in R.I. Gen. Laws Chapter 21-28 and 21 C.F.R. § 1306.08, for transmission of prescriptions to the dispensing pharmacy. The facsimile copy of the prescription may serve as the hard copy of the prescription except for prescription orders for Schedule II drugs in accordance with the provisions of R.I. Gen. Laws Chapter 21-28.

3. In addition to all other information required to be included on a prescription, an electronically transmitted prescription and facsimile prescriptions shall include the date of transmission.

4. A pharmacy receiving an electronic transmission prescription shall either receive the prescription in hard copy form or have the capacity to retrieve an electronic copy of the prescription from the pharmacy's computer memory.

5. The patient shall have the right to choose the manner in which his/her prescription is transmitted to the pharmacy.

6. The patient shall have the right to choose the pharmacy to which his/her prescription is transferred.

7. The pharmacist shall exercise professional judgment regarding the accuracy or authenticity of the transmitted prescription consistent with existing laws and Regulations.

8. Technological devices shall not be used to circumvent documentation, verification, or any provisions of the Act. Neither shall they be used to commit any other action that may be deemed unprofessional conduct.

9. Technological devices shall be located within the pharmacy.

1.4.24Emergency Prescription Refill

A. In the event a pharmacist receives a request for a prescription refill and the pharmacist is unable to readily obtain refill authorization from the prescriber, the pharmacist may dispense a one (1) time emergency refill of up to a ninety (90) day supply of the prescribed medication, providing that:

1. The prescription is not for a drug in Schedule II, III, IV, and V appearing in R.I. Gen. Laws Chapter 21-28;

2. The medication is essential to the maintenance of life or to the continuation of therapy of a chronic condition

3. In the pharmacist's professional judgment, the interruption of therapy might reasonably produce undesirable health consequences or may cause physical or mental discomfort; and

4. The dispensing pharmacist notifies the prescriber of the emergency dispensing within a reasonable time after such dispensing.

5. For an emergency prescription refill, there shall be appropriate documentation in the patient profile or on the hard copy of the prescription that an emergency refill has been dispensed.

216 R.I. Code R. § 216-RICR-40-15-1.4

Amended effective 5/17/2021
Amended effective 12/8/2022