216-40-15 R.I. Code R. § 1.5

Current through June 20, 2024

Section 216-RICR-40-15-1.5 - Pharmacies: Licensure Requirements

1.5.1Licensure Requirements: Pharmacies

A. Pursuant to R.I. Gen. Laws § 5-19.1-9, no person shall conduct, maintain, or operate a pharmacy in the State of Rhode Island without first obtaining and having in force a pharmacy license in accordance with the statutory provisions of the Act and the regulatory requirements of this Part.

B. Restricted Pharmacies: Pursuant to R.I. Gen. Laws § 5-19.1-10, upon application of the plan administrator or trustee of any trust, fund, pension plan, combination plan, or profit sharing plan, which is subject to the provisions of the Employee Retirement Income Security Act of 1974, 29 U.S.C. § 1001et seq., the Board may license a facility, hereinafter called a restricted pharmacy, for the purpose of dispensing pharmacy services to beneficiaries; provided, however, that no such license shall be granted unless the said trust, fund or plan demonstrates to the satisfaction of the Board that it is associated with another such trust, fund or plan already licensed in another State to own and operate a restricted pharmacy for the purpose of dispensing pharmacy services to its beneficiaries. Charges for such serviced shall be determined by the trustee or plan administrator. A restrictive pharmacy may, after written notice to the Board, limit its operation to a specific schedule of drugs.

1. Nothing in this section shall prohibit a restricted pharmacy from accepting or filling prescriptions by mail; provided, that the prescribing physician is verified, according to the procedures established by R.I. Gen. Laws Chapter 5-37, as licensed to practice in the State of Rhode Island or in any New England State.

C. Any pharmacy that utilizes latex gloves shall do so in accordance with the provisions of the Rules and Regulations pertaining to the Use of Latex Gloves by Healthcare Workers, in Licensed Healthcare Facilities, and by Other Persons, Firms, or Corporations Licensed or Registered by the Department (Part 20-15-3 of this Title).

D. A mechanism shall be in place to verify current licensure for every individual within the pharmacy who is licensed, certified, or registered by the State of Rhode Island. Documentation of current licensure shall be maintained by the pharmacy.

E. All pharmacies shall maintain an adequate number of pharmacists and pharmacy technicians to meet pharmacy workload demands, provide for adequate rest periods for personnel, and maintain public safety. Pharmacy staffing information shall be provided to the Department upon request, including but not limited to number of pharmacists and pharmacy technicians, prescription volume, pharmacy hours of operation, and staff schedules.

1.5.2Application for License and Fee

A. Application for a license (retail pharmacy, pharmacy within a medical institution, or restricted pharmacy) to conduct, maintain or operate a pharmacy in the State of Rhode Island shall be made in writing on forms provided by the Department and shall be submitted to the Department at least thirty (30) days prior to the expected operating date of the establishment for the transaction of business as a pharmacy.

B. The initial application must include the following:

1. Name and address of owner and/or manager and a notarized declaration of ownership and location;

2. Name of pharmacist-in-charge of the pharmacy;

3. Proposed location and address of place of business and blueprint or drawings of proposed floor plans;

4. For all pharmacies, the initial licensure 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);

5. An eProfile number from the national association of boards of pharmacy.

6. Pharmacies that compound sterile products shall provide an inspection report performed by the Board of Pharmacy from the pharmacy's home State, an independent organization such as NABP, or other similar agency as approved by the Board. Inspection shall be:

a. At the expense of the applicant;

b. Performed as a condition of initial licensure and annually thereafter; and

c. As deemed necessary by the Department to protect the public health and safety.

7. Such other information as the Board may deem necessary.

C. Applications for license renewal shall be made on forms provided by the Department and shall include such information as the Board may require, and the application must be accompanied by the license 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).

1.5.3Issuance and Renewal of License

A. Upon receipt of an application for a license the Board shall issue a license or renewal thereof for a period of one (1) year if the applicant meets the requirements of the Act and this Part. Said license, unless sooner suspended or discontinued, shall expire annually on the thirtieth (30^th) day of September following its issuance and may be renewed from year to year upon submission of application and license renewal fee. The applicant for renewal must obtain and submit an eProfile from the national association of boards of pharmacy.

B. A license shall be issued to a pharmacy in the name of the owner of the pharmacy. The license shall be issued for a specific location and shall not be transferable.

1. No pharmacist shall be a pharmacist-in-charge at more than one (1) pharmacy at the same time. Provided, however, a pharmacist may be designated as the pharmacist-in-charge at a maximum of two (2) pharmacies for a period not to exceed sixty (60) days for the purpose of transitioning to a new pharmacist-in-charge.

C. A license issued under this Part is the property of the State of Rhode Island and loaned to such licensee. It shall be kept posted in a conspicuous place in the licensed pharmacy.

1. The name of the pharmacist-in-charge shall be conspicuously displayed in the pharmacy.

1.5.4Change of Ownership and/or Location

A. When a change of ownership or location or when discontinuation of services is contemplated, the owner shall notify the Department in writing at least fourteen (14) days prior to the proposed action.

B. The pharmacy owner shall give the Department fourteen (14) days notice in writing prior to terminating services of a pharmacist-in-charge of a pharmacy, unless the pharmacist-in-charge vacates the position without notice. In this instance, the Department shall be notified in writing immediately of the change in pharmacist-in-charge.

C. When there is a change in ownership and/or location, the license shall immediately become void and shall be delivered to the Department.

1. The Board, or its designee, reserves the right to extend the expiration date of such license, allowing the pharmacy to operate, but under conditions stipulated by the Board for such time as shall be required for the processing of a new application.

2. The new applications must be filed in accordance with the provisions of §1.5.2 of this Part and be accompanied by the initial licensure fee pursuant to R.I. Gen. Laws § 5-19.1-9 and 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).

D. Pharmacy renovations or remodeling: Any renovations or remodeling of an existing pharmacy shall not be considered a change of location.

E. Patient records shall be retained and shall be capable of being retrieved, in a reasonable time period, for no less than two (2) years after a change of ownership is completed.

1.5.5General Requirements: All Pharmacies

A. Personnel: A licensed pharmacist shall be physically accessible at the address listed on the license in order to operate and manage the pharmacy at all times during the hours of operation when the pharmacy is open to the public. The pharmacist(s) shall be subject to all the statutory and regulatory provisions of this Part pertaining to the practice of pharmacy.

1. The owner shall ensure that a sufficient number of qualified, trained, competent and adequately supervised pharmacists and supportive personnel are employed to provide technical services, as well as ensuring that all such functions and activities are performed competently, safely, and without risk of harm to patients. The relationship between the supervising pharmacist and the supportive personnel shall be such that the pharmacist is fully aware of and responsible for all activities involved in the preparation and dispensing of medications prior to the release to the patient, including the maintenance of appropriate records.

2. The pharmacy shall be directed by a licensed pharmacist, hereinafter referred to as the pharmacist-in-charge, who shall be responsible for meeting the requirements set forth by Federal and State law, this section, and other applicable Regulations of the Board. The pharmacist-in-charge shall be thoroughly familiar with the specialized functions of pharmacy practice.

3. The pharmacist-in-charge of any pharmacy licensed in the State of Rhode Island and located in the State of Rhode Island or in another State, shall be licensed as a registered pharmacist in the State where the pharmacy is located.

4. The pharmacist-in-charge shall ensure that a sufficient number of pharmacists and supportive personnel are available to operate such pharmacy competently, safely, and to meet the needs of patients. All pharmacists shall be properly identified by name and licensure designation.

5. The owner shall develop and implement written policies and procedures to specify the duties to be performed by such pharmacists.

6. The pharmacist-in-charge of a pharmacy shall be responsible for no less than the following:

a. Provide to the Department a beginning inventory of all controlled substances, Schedules II-V, upon commencement of duties, and an ending inventory of same upon termination of duties as pharmacistin-charge;

b. Maintain adequate controls to prohibit the diversion of controlled substances and promptly execute DEA Form 106 (or its successor form) to the Drug Enforcement Administration and the Department in the event of a theft or loss of a controlled substance;

c. Report prescription forgeries, or attempted forgeries, as deemed necessary in the professional judgment of the pharmacist-in-charge, to the appropriate law enforcement authorities;

d. Ensure that the pharmacy dispensing area and equipment is in clean and orderly condition, that all licenses and registrations are current, that the "top ten" list and prices are conspicuously posted, and that the expiration dates of the pharmaceutical stock are periodically checked to ensure that no expired medications are dispensed;

e. Remove all controlled and non-controlled drugs from any pharmacy or institution upon sale or closure of the facility;

f. Comply with the Rules and Regulations for Disposal of Drugs (Part 20-20-1 of this Title), to utilize an alternative drug destruction mechanism for expired, excess/undesired controlled substances consistent with all Federal and State laws and Regulations;

g. Contact the Department whenever a concern arises that would affect the pharmacy's practice;

h. Ensure adherence to all policies and procedures for the operation of the pharmacy in accordance with the Act and this Part;

i. Be administratively responsible for the overall operation and conduct of the pharmacy.

B. Nothing in this Part shall prohibit a pharmacist from practicing pharmacy and providing pharmaceutical care outside of a pharmacy, including into Rhode Island, if the following conditions are met:

1. The pharmacist is licensed in Rhode Island or an employee of a non resident pharmacy licensed in Rhode Island;

2. The pharmacist has real-time electronic access to prescription records, patient profiles, or other relevant medical information and appropriately reviews the information;

3. Such records are protected from unauthorized access and use;

4. The pharmacist maintains the records or other patient-specific information created, collected, or used electronically; and

5. A pharmacy can permit pharmacists to work remotely, as operationally feasible and in accordance with applicable State and Federal law to conduct prescription data entry, prescription verification, clinical pharmacy and other functions that are normally performed in a pharmacy. Pharmacists shall only be permitted to work remotely as long as licensing reciprocity exists and the pharmacist resides in the United States or United States' Territory.

1.5.6Security

A. Every pharmacy must have and maintain proper security to limit accessibility of unauthorized personnel on the premises and to safeguard against the diversion of drugs, biologicals and medications.

B. Each pharmacy shall, at least while closed, utilize an alarm or other comparable monitoring system.

C. The Board shall deem additional security requirements necessary for the protection of the pharmacy and of the public.

D. The pharmacy shall place security cameras at multiple vantage points in the drug storage area within the pharmacy, including other adjacent areas of the building and pharmacy as deemed necessary by the Department and Board, which actively record and store video data for a minimum of 30 (thirty) days.

E. The pharmacy shall establish policies and procedures to address disasters and emergencies in order to protect the integrity of drugs and prevent unauthorized access to prescription medication.

1.5.7 Facilities, Equipment and Stock

A. Every pharmacy must be properly secured, equipped with facilities, apparatus, utensils, adequate reference materials relevant to the practice site, and a representative stock of pharmaceuticals, chemicals, drugs and preparations, so that prescriptions can be properly filled.

B. Each pharmacy shall adhere to written policies and procedures that require all stocks of medications to be inspected routinely for outdated, unusable or mislabeled products. Any outdated, unusable, or mislabeled medication or products shall be segregated to ensure that no such medications or products are dispensed.

1.5.8Space

The pharmacy shall be adequate in size and space to enable the pharmacist(s) to discharge all pharmaceutical functions and duties in a safe and effective manner, and to contain all required equipment, utensils, storage areas, including prescription compounding counter, and an area with adequate privacy to conduct patient counseling as well as other practice of pharmacy functions defined in this Part. The pharmacy shall be equipped with proper sanitary appliances and kept in a clean, sanitary and orderly manner.

1.5.9Pharmaceutical Services - Drug Recall

A. The pharmacist-in-charge shall ensure that a written procedure to handle drug product recalls. The procedure shall include, but is not limited to, the following:

1. A process for review of documents (i.e., prescriptions, drug orders, etc.) of the recalled lots

2. Notification to the recipients and prescribers of the recalled product, when appropriate

3. Personal inspection of all areas where drugs are stored to determine presence of recalled products

4. Quarantine of all recalled products to be marked "Quarantined-Do Not Use" until returned to manufacturer

5. Maintenance of written log of all recalls, the actions taken, and the results

1.5.10Emergency Kits

A. Drugs and devices may be provided in emergency kits for use by authorized personnel in nursing facilities, assisted living residences, medical institutions, or hospice care facilities (collectively "institutions") provided that:

1. The pharmacist-in-charge or designee, and the qualified health care staff shall jointly determine the drugs to be included in the kit by identity and quantity.

2. The emergency kit shall be sealed with a non-reusable, easily removable seal to prevent unauthorized access, and to ensure a proper environment for preservation of the drugs.

3. The exterior of the emergency kit shall be labeled so as to clearly indicate that it is an emergency drug kit. A listing of the drugs contained therein including name, strength and quantity of each drug or device shall be attached. Each emergency kit shall be inspected by a pharmacist or his designee monthly to check for expiration dates and the integrity of the seal.

4. All drugs within the emergency kit shall be labeled, if applicable, with the name, strength, lot number, manufacturer and expiration date.

5. Drugs and devices shall be removed from the emergency kit for administration to a patient only pursuant to a valid physician's order, by personnel authorized by the medical institution.

6. The pharmacy shall be notified whenever an emergency kit is opened. The pharmacist or designee shall re-stock, reseal and return the kit to the unit within a reasonable length of time.

7. The pharmacy may use automated storage and distribution devices as an emergency kit so long as the automated storage and distribution device complies with the provisions of this section.

1.5.11Repackaging

A. Drugs which are repackaged within a pharmacy for subsequent dispensing or administration shall be labeled to include:

1. The generic or trade name, strength, and quantity of drug

2. Control number assigned by the pharmacy which corresponds to the identification of the manufacturer, manufacturer' s expiration date, lot number of the drug, quantity repackaged, date repackaged and pharmacist responsible for repackaging;

3. The expiration date of the drug being repackaged shall be one (1) year from the date the drug is repackaged or the expiration date on the manufacturer's container, whichever is earlier.

B. The pharmacy shall have and use facilities, personnel, operational practices, packaging material, and control procedures to assure that the purity, integrity, safety, and effectiveness of the drugs are not affected by such repackaging. All repackaging must be performed by or under the supervision of a pharmacist.

C. A pharmacy may repackage a patient's previously dispensed medication provided that the pharmacy implements policies and procedures that include but are not limited to the following requirements:

1. The patient or patient's responsible party requests that the pharmacy repackage the medication for ease of administration in unit dose containers.

2. The pharmacy receiving the previously dispensed medication records the prescription medication received, all label information, and stores the medication separate from the pharmacy's inventory.

3. The medication is repackaged in an appropriate USP approved multi-unit, unit-of-use, or single-unit dose container.

4. The pharmacy records the previously repackaged medication quantity, includes all information on the original prescription label, and a pharmacist verifies the medication that was repackaged is correctly labeled by the pharmacy.

1.5.12Investigational Drugs

A. The pharmacist-in-charge and the medical staff shall be responsible for developing policies and procedures for ensuring proper labeling pursuant to R.I. Gen. Laws Chapter 21-31, Storage, Distribution, administration and Control of Investigational Drugs.

1. Investigational drugs shall be relabeled "For Investigational Use Only."

2. A perpetual inventory record for investigational drugs shall be maintained. The record shall contain:

a. Drug's name, dosage form and strength, lot number, expiration date;

b. Name, address, telephone number of the sponsor;

c. Protocol number;

d. Information on disposition of the drug;

e. Recording dispenser's initials.

3. Investigational drugs shall be segregated from commercial products.

4. The pharmacist-in-charge shall be responsible for the provision of staff education regarding investigational drugs.

5. Prior to dispensing, any investigational drug, dose and treatment schedule should be verified against the protocol.

B. Any information pertaining to potential adverse effects, precautions, compounding and preparation requirements, etc., of the investigational drug shall be reviewed by the pharmacist.

1.5.13Adverse Drug Reactions (ADRs) and Medication Errors

A. Medication Use Evaluation Program:

The pharmacist-in-charge shall establish policies and procedures to increase the effectiveness and minimize the risk of drug use. Policies and procedures shall include defining, monitoring, detecting, reporting and reviewing medication errors and adverse drug reactions (ADRs). ADRs deemed to be significant by the pharmacist shall be reported to the FDA's MedWatch Program. Vaccine-related adverse events shall be reported to the CDC using VAERS and adverse events involving Dietary Supplements shall be reported to https://www.safetyreporting.hhs.gov.

B. Patient Profile

1. A patient record system shall be maintained by all pharmacies for patients for whom prescriptions are dispensed. The patient record system 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. The pharmacist shall make a reasonable effort to obtain, record, and maintain the following information:

a. Full name of the patient for whom the drug is intended

b. Address and telephone number of the patient

c. Patient's age or date of birth

d. Patient's gender

e. A list of all prescriptions obtained by the patient at the pharmacy maintaining the patient record during the twelve (12) months immediately preceding the most recent entry showing the name of the drug or device, prescription number, name and strength of the drug, the quantity and date received, and the name of the practitioner, and

f. Pharmacist comments relevant to the individual's drug therapy and drug allergies, including any other information peculiar to the specific patient or drug.

C. The pharmacist shall make a reasonable effort to obtain from the patient or the patient's agent any known allergies, drug reactions, idiosyncrasies, and chronic conditions of the patient and the identity of any other drugs, including over-the-counter drugs, or devices currently being used by the patient which may relate to prospective drug review, and shall record this information in the patient's profile.

D. The patient record shall be maintained for a period of not less than two (2) years from the date of the last entry in the patient profile record. This record may be a hard copy or in a computerized form.

E. Prospective Drug Review

1. A pharmacist shall review the patient record and each prescription presented for dispensing for purposes of promoting therapeutic appropriateness by identifying:

a. Over-utilization or under-utilization

b. Therapeutic duplication

c. Drug-disease contraindications

d. Drug-drug interactions

e. Incorrect drug dosage or duration of drug treatment

f. Drug-allergy interactions

g. Clinical abuse/misuse

h. Food-drug interaction

2. Upon recognizing any of the above, the pharmacist shall take appropriate steps to avoid or resolve the problem which shall, if necessary, include consultation with the practitioner or other appropriate persons.

F. Continuous quality improvement programs

1. Notwithstanding practices constituting unprofessional practice indicated in this Part, any pharmacy that actively reports dispensing errors and the analysis of such errors to a patient safety organization shall be deemed in compliance with this section.

2. Pharmacies not actively reporting to patient safety organizations shall implement a program for continuous quality improvement in compliance with this section.

a. Notification requirements

(1) A pharmacy intern or pharmacy technician who identifies or learns of a dispensing error shall immediately notify a pharmacist on duty of the dispensing error.

(2) A pharmacist on duty shall appropriately respond to the dispensing error in a manner that protects the health and safety of the patient.

(3) A pharmacist on duty shall immediately notify the patient or the person responsible for administration of the drug to the patient and communicate steps to avoid injury or mitigate the error if the patient is in receipt of a drug involving a dispensing error that may cause patient harm or affect the efficacy of the drug therapy. Additionally, reasonable efforts shall be made to determine if the patient self-administered or was administered the drug involving the dispensing error. If it is known or reasonable to believe the patient self-administered or was administered the drug involving the dispensing error, the pharmacist shall immediately assure that the prescriber is notified.

b. Documentation and record requirements; remedial action:

(1) Documentation of the dispensing error must be initiated as soon as practical, not to exceed three (3) days from identifying the error. Documentation shall include, at a minimum, a description of the event that is sufficient to allow further investigation, categorization, and analysis of the event.

(2) The pharmacist-in-charge or designee shall perform a systematic, ongoing analysis, as defined in these regulations, of dispensing errors. An analysis of each dispensing error shall be performed within thirty (30) days of identifying the error.

(3) The pharmacist-in-charge shall inform pharmacy personnel of changes made to pharmacy policies, procedures, systems, or processes as a result of the analysis.

(4) Documentation associated with the dispensing error need only to be maintained until the systematic analysis has been completed. Prescriptions, dispensing information, and other records required by Federal or state law shall be maintained accordingly.

(5) A separate record shall be maintained and available for inspection to ensure compliance with this section for twelve (12) months from the date of the analysis of dispensing errors and shall include the following information:

(AA) Dates the analysis was initiated and completed;

(BB) Names of the participants in the analysis;

(CC) General description of remedial action taken to prevent or reduce future errors; and

1.5.14Patient Counseling

A. After receipt of a new prescription and following a review of the patient's record, a pharmacist or pharmacy intern, as defined in the Act, shall initiate discussion of matters which will enhance or optimize drug therapy with each patient or care giver of such patient. Such discussion shall be in person whenever practicable, by telephone or electronic means, and shall include appropriate elements of patient counseling, as is appropriate for the patient in the professional judgment of the pharmacist. The offer to counsel may be delegated by the pharmacist. Nothing in this section will prohibit a pharmacist from counseling a patient on a refill prescription when deemed necessary in the professional judgment of the pharmacist. Such elements may include the following:

1. The name and description of the drug;

2. The dosage form, dose, route of administration, dosing schedule, and duration of drug therapy;

3. Intended use of the drug and expected action;

4. Special directions and precautions for preparation, administration, and use by the patient;

5. Common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;

6. Techniques for self-monitoring drug therapy;

7. Proper storage;

8. Prescription refill information;

9. Action to be taken in the event of a missed dose; and

10. Pharmacist comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug.

B. Alternative forms of patient information shall be used, when deemed necessary in the professional judgment of the pharmacist, to supplement patient counseling when appropriate. Examples to include written information leaflets, pictogram labels, video programs, etc.

C. Patient counseling and patient profiles, as described above and defined in this Act shall not be required for inpatients of a hospital or institution, or any other licensed health-care facility, where other licensed healthcare professionals are authorized to administer the drugs.

D. A pharmacist shall not be required to counsel a patient or care giver when the patient or care giver refuses such consultation. Such refusal shall be documented in writing.

1.5.15Prescription Transfer

A. Prescriptions may be transferred an unlimited amount of times for the purposes of filling or refilling between pharmacies by any means either verbally, electronically, or via fax provided that the pharmacies adhere to the following requirements:

1. The prescription is for a drug that is lawfully able to be filled.

2. The pharmacist, or supportive personnel, as permitted, transferring the prescription cancels the original prescription in his/her records, and indicates in the prescription record to whom the prescription was transferred, including the name of the pharmacy, the date of the transfer, and the name or initials of the transferring pharmacist or supportive personnel.

3. The pharmacist, or supportive personnel, as permitted, receiving the transferred prescription shall:

a. Note that it is a transferred prescription

b. Record all of the following information in the prescription records, in addition to other information required by law:

(1) Date of issuance of the original prescription

(2) Original number of refills authorized on prescription

(3) Complete refill record from original prescription

(4) Number of valid refills remaining

c. File number of the original prescription

d. Name of the pharmacy and pharmacist or supportive personnel from whom the prescription was transferred

4. A pharmacist, or supportive personnel, as permitted, may transfer a prescription to another pharmacist or supportive personnel employed by the same corporation without regard to the requirements of §§1.5.15(A)(2) and (3) of this Part, provided that both have access to the same computerized prescription transfer system which contains the prescription and refill records and incorporates procedures to prevent unauthorized refills.

5. If the prescription is for a controlled substance in Schedules III, IV, or V, the pharmacies shall comply with 21 C.F.R. § 1306.26.

B. The requirements of §§1.5.15(A)(2) through (4) of this Part are excepted when an offsite pharmacy that provides pharmaceutical services to a nursing facility, assisted living residence, mental health institution, medical institution, hospital, or hospice care facility pursuant to a valid medication order or prescription directly transmits and shares the quantity of a prescription or medication order with another pharmacy if:

1. The transmission and sharing of the prescription or medication order is for the limited purpose of ensuring that drugs or devices are attainable to meet the immediate needs of patients for up to a seventy-two (72) hour supply or the originating pharmacy cannot provide services for the institutional facility on an ongoing basis due to a State of Emergency declared by an authorized government official or agency or unforeseen circumstances requiring that the pharmacy temporarily cease operations;

2. The originating pharmacy obtains consent from the facility, home health agency or hospice agency to share the pharmacy services for its residents;

3. The originating pharmacy provides a copy of a valid verbal, electronic, or written prescription or medication order to the receiving pharmacy prior to dispensing by the receiving pharmacy; and

4. The receiving pharmacy maintains responsibility for performing all requirements under applicable pharmacy statutes and Regulations when dispensing the portion of the prescription or medication order.

1.5.16Beyond-Use Dating on Labels

A. It shall be the responsibility of the dispenser, taking into account the nature of the drug repackaged, the characteristics of the container, and the storage conditions to which the article may be subject, to determine a suitable beyond-use date to be placed on the label. In addition:

1. The maximum beyond-use date that may be placed on the prescription container label shall be one (1) year from the date the drug is dispensed or the expiration date on the manufacturer's container, whichever is earlier.

2. Where an expiration date on a product is dated only by the month and year, the intended expiration date shall be considered to be the last day of the stated month.

1.5.17Necessity of Prescription Label

A. In accordance with R.I. Gen. Laws § 5-19.1-18, to every box, bottle, jar, tube or other container of a prescription which is dispensed, a label shall be attached, the contents of which shall include:

1. The name of the prescriber;

2. The full name of the patient;

3. The name and address of the pharmacy;

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

5. Quantity and strength of the drug dispensed;

6. The date of dispensing;

7. The prescription number;

8. The expiration date of the prescription in accordance with §1.5.16 of this Part; and

9. A full instruction on the use of the product in plain language.

B. Said label shall be printed, typed, or a combination of printed and typed, but shall not be handwritten, except in the case of an emergency.

C. No person shall alter, deface, or remove any label so affixed.

D. The requirements of this section shall not apply to an order to dispense a drug for immediate administration to a licensed hospital, nursing facility, or hospice facility in-patient.

1.5.18Generic Substitutions

A. Pharmacists when dispensing a prescription shall, unless requested otherwise by the individual presenting the prescription in writing, substitute drugs containing all the same active chemical ingredients of the same strength, quantity, and dosage form as the drug requested by the prescriber from approved prescription drug products in accordance with the provisions of R.I. Gen. Laws §§ 21-31-16 and 21-31-15(l)(1), unless ordered by the prescribing physician to dispense as brand name necessary on the prescription form, or if the prescriber gives oral direction to that effect to the dispensing pharmacist.

B. The requirements of §1.5.18(A) of this Part shall not apply to an order to dispense a drug for immediate administration to a licensed hospital, nursing facility or hospice facility in-patient.

C. The pharmacist shall make a product selection from approved prescription drug products and shall pass the savings on to the ultimate consumer. When a drug product selection is made, the pharmacist shall indicate the product dispensed on the written prescription or on the oral prescription, which has been reduced to writing or product information may be maintained on a computerized system if information is readily retrievable.

1.5.19Biosimilar Interchange

A. Pharmacists when dispensing a biological product shall, unless requested otherwise by the patient, interchange with a less expensive product that is a highly similar product to the FDA-approved biological product, known as a reference product, which has no clinically meaningful differences in terms of safety and effectiveness from the reference product, and the FDA has:

1. Licensed and determined meets the standards for interchangeability pursuant to 42 U.S.C. § 262(k)(4) or lists of licensed, biological products with reference product exclusivity and biosimilarity or interchangeability evaluations; or

2. Determined is therapeutically equivalent as set forth in the latest edition of or supplement to, the United States Food and Drug Administration's Approved Drug Products with Therapeutic Equivalence Evaluations.

1.5.20Central Database - Operation

A. In accordance with R.I. Gen. Laws § 5-19.1-17, pharmacies operated by a person pursuant to the Act may refill prescriptions which have been previously dispensed by an affiliated pharmacy, provided, that prior to dispensing a refill the pharmacy refilling the prescription verifies the appropriateness of the refill through a centralized database.

B. Clinic pharmacies operated by a health maintenance organization licensed under R.I. Gen. Laws Chapter 27-41 and the Act may refill prescriptions which have been previously dispensed by another health maintenance organization clinic pharmacy, provided that prior to dispensing a refill the pharmacy refilling the prescription verifies the appropriateness of the refill through a centralized database of that health maintenance organization.

C. Disclosure of prescription information to any other person(s) other than agents of properly licensed pharmacies pursuant to §§1.5.20(A) and (B) of this Part is prohibited.

D. Disclosure of prescription information is permitted only to those directly involved in patient care consistent with R.I. Gen. Laws Chapter 5-37.3, the "Healthcare Communications and Information Act" and other applicable Federal and State laws.

E. The disclosure of prescription information to researchers may only be authorized in accordance with Federal policy for the protection of human subjects.

1.5.21Product Selection

A pharmacist may alter the prescribed dosage form of a medication, if in the professional judgment of the pharmacist, the form dispensed meets the bioequivalency of the dose prescribed and it is appropriate for the patient.

1.5.22Poison Prevention Packaging

A. All drugs and substances cited in the Federal Poison Prevention Packaging Act Regulations, 15 U.S.C. § 1471et seq., shall be packaged and dispensed in accordance with said Regulations.

B. Documentation shall be maintained by the pharmacy to record those instances when a non-child-resistant safety cap container has been requested by a consumer.

1.5.23Product Verification

Verification by a pharmacist of a filled prescription must include a verification of the prescription label and product against the original or scanned prescription.

1.5.24Therapeutic Substitution

A. Therapeutic substitutions by pharmacists are permitted in situations requiring compliance with a formulary prepared by the pharmacy and therapeutics committee, and agreed to by the staff physicians of the facility:

1. In a hospital, licensed pursuant to R.I. Gen. Laws Chapter 23-17; or

2. In a nursing facility, medical institution, or hospice care facility with contracted pharmaceutical services pursuant to §1.6.1 of this Part and licensed under R.I. Gen. Laws Chapter 23-17.

1.5.25Return to Stock of Undelivered Medications

A. Prescriptions that have not been picked up by or delivered to patients may be returned to stock. The pharmacist shall be responsible for the development of written policies and procedures that shall include, but not be limited to, the following:

1. Drugs returned to stock have been maintained to assure their integrity;

2. No drugs returned to stock have expirations dates that exceed twelve (12) months from the date of dispensing of original prescription;

3. Patient information on prescription labels have been redacted to protect patient confidentiality; and

4. Given a manufacturer or FDA recall for a drug product, pharmacist shall assume products held in containers without lot numbers are included in the recall and proceed accordingly.

1.5.26General Requirements: Retail Pharmacies

A. Space. Any new pharmacy shall have an area of not less than two hundred and fifty square feet (250').

B. List of Drugs Posted. Each pharmacy:

1. Shall conspicuously display the list of the ten (10) prescribed health maintenance prescription drugs compiled by the Director at or adjacent to the place in the pharmacy where prescriptions are presented for compounding and dispensing;

2. Shall, upon request, provide to a consumer who possesses a prescription for any listed prescription drug, the current selling price of that drug; and

3. May change the current selling price and the posting of that price on the list at any time.

C. Each pharmacy shall post, in a clear and legible form, on that list, the current selling price of each prescription drug listed. Current selling price means the actual price to be paid by a retail purchaser to the pharmacy for any prescription drug listed at the usual strength and amount listed.

D. The requirements of this section do not apply to an order to dispense a drug for immediate administration to a hospital patient.

1.5.27General Requirements: Institutional Pharmacies

A. Physical Requirements. An institutional pharmacy shall have sufficient floor space allocated to it to ensure that drugs are prepared in sanitary, well-lighted and enclosed places. It shall have sufficient equipment, supplies and physical facilities for proper compounding, dispensing and storage of drugs, including parenteral preparations and for the provision of pharmaceutical care. All work surfaces shall be free of equipment, supplies, records and labels unrelated to the preparation of medications. The equipment and physical facilities shall include, but are not limited to, the following:

1. Compounding and dispensing areas;

2. Physically separate parenteral solution additive area when solutions are compound in the pharmacy as described in § 1.7 of this Part;

3. Receiving and storage areas;

4. Packaging and repackaging areas;

5. Office space sufficient to allow for administrative functions without interference with the safe compounding and dispensing of medications and security of the pharmacy.

B. After-hours Pharmacy Services. The pharmacist-in-charge shall establish policies and procedures for the provision of a limited supply of medications for filling of urgent orders to patients of the medical institution after the scheduled hours of operation of the pharmacy. The pharmacist-in-charge shall provide for the provision of pharmaceutical care after normal working hours by use of an "on call" pharmacist accessible to the medical institution after hours. The institutional pharmacy may enter into a contractual arrangement with another pharmacy or pharmacist for the provision of such services. Medications may be accessed from a pharmacy-designated area. The policies and procedures shall address:

1. A list of those individuals authorized by the pharmacist-in-charge to remove medications from the pharmacy-designated area

2. A list of medications authorized for removal from the pharmacy-designated area determined by the pharmacist-in-charge or designee, and the medical staff of the medical institution. The pharmacist in charge shall limit the number of medications, quantity and dosage forms to maximize patient safety. Medications shall be removed from the designated area in unit-of-use packaging, whenever possible. If a non-unit-dosed medication is needed when the pharmacy is closed, the bulk medication container shall be signed out. When the pharmacy re-opens, the pharmacist shall retrieve the bottle and dispense the necessary amount of medication. The bottle shall be returned to the pharmacy within twenty-four (24) hours after the pharmacy re-opens.

3. Documentation of medications removed from the pharmacy-designated area, which shall include, but not be limited to, medication name, strength, signature of authorized person removing medications, quantity and name of patient

4. Methods for performing a periodic review of those policies and procedures

C. Medication Distribution and Control. The pharmacist-in-charge shall establish policies and procedures relating to the procurement, distribution and control of all drug products used in the medical institution.

1. Medication Orders

a. Medications are to be prescribed, dispensed and administered only upon orders of authorized practitioners and medication orders transmitted to the pharmacy in an appropriate manner.

b. A licensed pharmacist in the institutional pharmacy shall review all medication orders for appropriateness upon receipt in the pharmacy prior to dispensing, except orders initiated in the operating room, emergency room, procedural rooms, and ambulatory care centers. Medication orders written when the pharmacy is closed shall be reviewed within twenty-four (24) hours after the pharmacy re-opens.

c. All patient medication orders shall be contained in the patient's medical record.

d. Medication orders shall contain:

(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 of drug prescribed;

(5) Directions for use;

(6) If a written prescription, prescribing practitioner's signature;

(7) If an electronically transmitted prescription, prescribing practitioner's electronic signature or type written signature; and

(8) Oral prescriptions shall be reduced promptly to writing by the pharmacist or intern and stored either electronically or in hard copy format.

e. Medication orders for controlled substances must comply with all applicable Federal and State laws.

f. A valid medication order may be transmitted to a licensed pharmacy by the following means:

(1) Delivery of the original, signed written medication order.

(2) Electronically by a nurse or authorized agent of the prescriber in a hospital, nursing facility, medical institutions, or hospice care facilities via a secure, interoperable information technology system that exchanges data accurately, effectively and in compliance with applicable laws.

(3) Verbally by an authorized prescriber or the prescriber's authorized designated agent. For the purposes of this section, nurses in nursing facilities shall be considered authorized designated agents.

(4) Via facsimile by a prescriber or the prescriber's authorized designated agent. If the order was initially received verbally, the transmitted document shall include the name of the prescriber, the name of the agent who received and transcribed the medication order.

2. Medication Storage and Security

a. All areas designated for medication storage shall have and shall maintain proper security to limit accessibility of unauthorized personnel on the premises and to safeguard against diversion of drugs, biologicals and medications.

b. All medications shall be stored in designated areas under proper conditions of sanitation, temperature, light, moisture, ventilation, and segregation to ensure medication integrity. Medications shall be stored in accordance with medication labeling pursuant to the Federal and State Food Drug and Cosmetic Acts, 21 U.S.C. § 301et seq. and R.I. Gen. Laws Chapter 21-31.

c. Each pharmacy shall adhere to written policies and procedures that require all stocks of medications to be inspected routinely for outdated, unusable or mislabeled products.

d. Floor stock of medications shall be limited to medications for emergency use, non-legend medications that are routinely used, and limited medications as designated by the facility.

e. All medication areas including auxiliary drug supplies, unit dose carts and emergency kits, shall remain secured at all times. All medications must be adequately secured to restrict access by unauthorized personnel.

f. Sample medications shall be procured, stored, dispensed and/or donated to charitable institutions in accordance with the Federal Food Drug and Cosmetic Act.

3. Labeling

a. All drugs dispensed within a medical institution shall be labeled and identified up to the point of administration.

b. Whenever a drug is added to a parenteral admixture, it shall be labeled with a supplementary label indicating the name and amount of the drug added, expiration date and expiration time, if applicable. For admixtures prepared outside the pharmacy, the pharmacist-in-charge shall develop policies and procedures for preparation and labeling.

c. Labels for outpatient medications shall comply with R.I. Gen. Laws § 21-31-15(l)(l).

4. Records. The pharmacist-in-charge shall develop a system of daily accountability for medication compounding and dispensing that shall permit the identification of the responsible pharmacist. Readily retrievable records of accountability shall be maintained for at least two (2) years. At a minimum, this system shall identify all personnel who perform these activities and the pharmacist responsible for:

a. Interpretation and appropriateness of new medication orders;

b. Profile entry of new medication orders;

c. Dispensing of new medication orders including "stat" doses;

d. Daily cart fills;

e. Compounding medications; and

f. Periodically assessing the quality of pharmacy procedures for preparation and release of drugs for replenishment of floor stock, ancillary drug supplies, emergency kits and automated dispensing devices in locations outside the pharmacy.

5. Patient's personal medications may be administered to the patient in the event that the hospital does not stock the medication, and shall be arranged per hospital policy.

a. Notwithstanding the provision of §1.5.27(C)(5) of this Part, or any other provision of this Part to the contrary, a hospital may refuse to store its patients' personal medication in its pharmacy and may direct that personal medications be stored securely in the patients' rooms or returned to the patients' homes. A patient's personal medication may be administered to the patient during a hospital stay, if necessary.

6. Emergency Outpatient Medications

a. The pharmacist-in-charge and medical staff shall establish policies and procedures for the dispensing of medications from the emergency room.

(1) Only a licensed prescriber shall be authorized to dispense medications to patients in an emergency situation.

(2) Emergency medications shall be labeled in accordance with R.I. Gen. Laws § 21-31-15(l)(l).

7. Monitoring Drug Therapy. The pharmacist shall review the appropriateness of the choice of medications for the patient and the patient's therapeutic regimen, pursuant to §1.5.13(C) of this Part.

a. Pharmacists shall have access to the following information:

(1) Admission diagnosis;

(2) Age, weight, height and sex;

(3) History of allergies and/or previous adverse drug reactions;

(4) Current and discontinued medications;

(5) Co-morbid disease states;

(6) Pertinent laboratory information.

b. The pharmacist shall review each medication order and, in the case of an identified, significant problem or opportunity for improvement, the pharmacist shall contact the prescribing practitioner. All such communications shall be documented electronically or in writing. Pharmacy interventions shall be reviewed with appropriate staff committees on a routine basis.

c. Medication Use Evaluation Program: The pharmacist-in-charge and medical staff shall establish policies and procedures to increase the effectiveness and minimize the risk of drug use. Policies and procedures shall include defining, monitoring, detecting, reporting and reviewing the following:

(1) Adverse Drug Reactions (ADR): ADRs that the pharmacist deems to be significant shall be reported to the FDA's MedWatch Program. Vaccine-related adverse events shall be reported to the CDC.

(2) Medication Errors: Special consideration shall be given to measures to prevent medication administration errors associated with preparing parenteral and sterile products.

(3) Medication Use Evaluation: The system shall identify, and resolve actual and potential medication-related problems, and prevent potential medication problems that could interfere with optimum patient outcomes from medication therapy.

1.5.28Standing Orders

A. A Rhode Island licensed pharmacist may engage in a standing order pursuant to a signed standing order by a Rhode Island licensed physician or other practitioner. More than one (1) pharmacist may engage in a standing order signed by a Rhode Island licensed physician or other prescriber.

1. The signed standing order must be kept on file and readily retrievable at the site where the engagement in said order is taking place.

2. All standing orders must be approved by the BOP, the BMLD and the Director, each party listed herein may request revisions to any proposed standing order as a condition of approval. Each proposed standing order must first be submitted to the BOP. Upon BOP approval, the proposed standing order will be forwarded to the BMLD. Upon BMLD approval the standing order will be sent to the Director for approval.

3. No proposed standing order may commence until it is approved by the Director. The Director may also terminate a standing order at any time.

B. Standing orders must include, but are not limited to the following:

1. An explanation of the standing order;

2. The criteria for the standing order;

3. The training requirements for the individuals participating in the standing order, if any;

4. The medicine, medical supply, and/or medical equipment that may be supplied and/or administered per the standing order;

5. The indications for which the medicine, medical supply, and/or medical equipment is to be administered, prescribed, or dispensed;

6. The number of dose(s) of the medicine, medical supply or equipment per the standing order;

7. The route of administration or use;

8. Record of the clinical documentation in paper or electric form and any other documentation per State or Federal requirements;

9. The effective dates of the standing order.

C. If a standing order lists more than one (1) medicine, medical supply, and/or equipment for the treatment of a condition, the purpose of each medicine medical supply or equipment must be listed on the standing order.

D. The standing order must not exceed a two (2) year time period. If a renewal is requested, a review per §1.13.1(A)(2) prior to the anniversary date of the standing order is required.

216 R.I. Code R. § 216-RICR-40-15-1.5

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