Louisiana Regulations
Department of Health/Board of Pharmacy
Vol. 47, No. 11, Louisiana Register 2021-11-20 pp.1641-1646
PUBLICATION DATE: 11/20/2021
ACTION DATE: 11/20/2021
EFFECTIVE DATE: 11/20/2021
PUBLICATION TYPE: Register
DOCUMENT NUMBER: 2111-005
REGISTER SOURCE: Vol. 47, No. 1, Louisiana Register 2021-01-20 pp.130-136
PUBLICATION DATE: 01/20/2021
ACTION DATE: 01/20/2021
COMMENT DEADLINE: 02/25/2021
PUBLICATION TYPE: Register
DOCUMENT NUMBER: 2101-025

RULE

Department of Health

Board of Pharmacy

Pharmacists, Pharmacies and Prescriptions

(LAC 46:LIII.Chapters 5, 11, 24, 25 and 27)

In accordance with the provisions of the Administrative Procedure Act (R.S. 49:950 et seq.) and the Pharmacy Practice Act (R.S. 37:1161 et seq.), the Louisiana Board of Pharmacy has amended several sections of its rules relative to pharmacists, pharmacies and prescriptions. Pursuant to Act 454 of the 2018 Legislature, the board conducted a public hearing on June 26, 2019 to solicit comments and testimony as to whether any of its rules were contrary to law, outdated, unnecessary, overly complex or burdensome. Subsequent to its evaluation of those comments, the board solicited additional stakeholder input in formulating these Rule changes. The changes in §521 update and simplify the rule relative to medication administration. The changes in §1103 removed outdated minimum specifications for prescription departments. The changes in §1105 provides additional time for the reporting of changes in the pharmacist-in-charge at pharmacies to the board. The change in §1107 provides that no person credentialed by the board may be forced to practice pharmacy for longer than six hours without a rest break. The changes in §1123 permit the disposal of hard copy prescription records after they have been imaged and stored in the electronic recordkeeping system and make technical corrections. The change in §1131 removes an outdated requirement relative to applications for pharmacy permits. The changes in §2425 remove outdated minimum specifications for prescription departments in telepharmacy dispensing sites, provides that pharmacy technician candidates may not practice in such sites, clarify the patient counseling requirements in such sites, and make technical corrections. The changes in §2511 remove a provision relative to facsimile prescriptions which expired in December 2016. The changes in §2513 clarify the responsibilities of pharmacists receiving and verifying prescriptions. The change in §2521 extends the quantity of medication which a pharmacist may dispense pursuant to an emergency refill. The changes in §§2519, 2525, 2745 and 2747 extend the expiration date of prescriptions for controlled substances listed in Schedule V from six months to one year in conformance with the federal rules and make technical corrections. This Rule is hereby adopted on the day of promulgation.

Malcolm J Broussard

Executive Director

2111#005

Title 46

PROFESSIONAL AND OCCUPATIONAL

STANDARDS

Part LIII. Pharmacists

Chapter 5. Pharmacists

Subchapter B. Professional Practice Procedures

§521. Administration of Medications

A. Pharmacists and pharmacy interns who intend to administer medications to their patients shall obtain a medication administration registration from the board prior to engaging in such activity. Pharmacy interns in possession of the medication administration registration may only administer medications while under the supervision of a pharmacist in possession of a medication administration registration.

B. Medication Administration Registration

1. Eligibility a. The applicant shall possess a pharmacist license or pharmacy intern registration issued by the board; and further, such credential shall be active and valid for practice.

b. The applicant shall demonstrate current life safety certification by the American Heart Association through its Basic Cardiac Life Support (BLS) for Healthcare Providers course, or its successor, or by a board-approved equivalent.

c. The applicant shall demonstrate successful completion of a certificate program for medication administration which has been approved by the board. The board may approve any program which is an evidence-based didactic course that meets current Centers for Disease Control and Prevention (CDC) training guidelines, or other guidelines as designated by the board, and provides a minimum of 20 hours of instruction and experiential training in the following content areas:

i. standards for medication administration practices; ii. basic immunology; iii. recommended medication administration schedules; iv. vaccine storage and management; v. informed consent; vi. physiology and techniques for medication administration; vii. pre- and post-administration assessment and counseling; viii. medication administration record management; and ix. management of adverse events, including identification and appropriate response, as well as documentation and reporting.

2. Application for Initial Issuance a. The applicant shall complete the application form supplied by the board and furnish the information requested.

b. The applicant shall retain evidence of their education, training and continuing competency; and further, shall furnish copies of such documentation upon request by the board.

c. The board shall issue the registration with an expiration date matching the expiration date of the life safety certification card supplied with the application.

3. Renewal a. In the event the pharmacist license or pharmacy intern registration expires before the expiration date of the medication administration registration, then the authority to administer medications shall terminate. The authority to administer medications requires the primary credential as well as the medication administration registration to be active at the same time.

b. The renewal of an expired medication administration registration requires documentation of a current life safety certification as described above.

c. To maintain continuing competency for medication administration, the pharmacist shall acquire at least one hour of continuing education per year related to this topic. Continuing education activities obtained for this purpose shall be acquired from a provider accredited by the Accreditation Council for Pharmacy Education (ACPE); and further, the credit earned for such programs may be included within the total number of credits required to renew the pharmacist license.

C. Vaccines.

1. The pharmacist shall maintain and furnish the following information to the practitioner within 24 hours of the administration:

a. name and address of the patient; b. age of the patient, if under 14 years of age; c. name of the patient's primary care physician as provided by the patient or patient's agent; d. name, manufacturer, and lot number of the vaccine administered; e. amount administered; f. date of vaccine administration; g. site of vaccine administration; h. route of administration; and i. name, address, and telephone number of the pharmacist administering the vaccine.

2. The immunizing pharmacist or his designee shall report the immunization to the state immunization registry within 72 hours of the administration of the immunization.

D. Pharmacies hosting immunization activities, as well as pharmacists administering immunizations in a location other than a pharmacy, shall comply with the following minimum standards.

1. There shall be sufficient staffing available for the pharmacist to administer the immunization and monitor the patient afterward without distraction from other responsibilities.

2. To facilitate emergency management of anaphylactic reactions, there shall be adequate supplies of medication and equipment, as well as pre-determined procedures for the arrangement of emergency medical services.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1989, amended LR 29:2085 (October 2003), effective January 1, 2004, LR 34:1409 (July 2008), amended by the Department of Health, Board of Pharmacy, LR 46:578 (April 2020), LR 47:1641 (November 2021).

Chapter 11. Pharmacies

Subchapter A. General Requirements

§1103. Prescription Department Requirements

A. A prescription department of a pharmacy shall provide sufficient floor space, fixtures, equipment and supplies commensurate with the nature and scope of the pharmacy's practice to ensure that drugs are compounded and dispensed in a well-lighted, ventilated, climate controlled, and safely enclosed structure.

B. Restricted. A prescription department is a restricted area.

C. Prescription Department Plumbing. A sink equipped with hot and cold running water shall be located within the prescription department. A sink located in a pharmacy restroom shall not be sufficient to satisfy this requirement.

D. Electronic Record Keeping System. An electronic record keeping system shall be utilized in a pharmacy department and shall be a complete, accurate, and readily retrievable prescription record keeping and storage system.

E. Drug Inventory

1. Storage. The pharmacy shall provide an adequate prescription inventory in order to compound and dispense prescription orders. Drugs that require special storage shall be properly stored.

2. Missing or Damaged Inventory. When significant drug inventory is missing or damaged for any reason, the pharmacy owner or pharmacist-in-charge shall file with the board a signed statement of the circumstances of such occurrence and evidence that the appropriate law enforcement authorities were notified as required by law.

F. Pharmacy Security. The prescription department or the premises housing the prescription department shall be adequately secured by the installation of partitions and secured entrances, which shall be locked by a pharmacist and made inaccessible when the prescription department is closed. The prescription department or any premises housing a prescription department shall be adequately secured by an alarm system.

G. Emergency Access. An additional key to the prescription department may be maintained in a secure location outside the prescription department for use during an emergency. A log shall be maintained with the key, indicating the name of each non-pharmacist using this key, the date and time of entry, and the nature of the emergency.

H. References. The current edition of the Louisiana

Board of Pharmacy Laws and Regulations shall be maintained and readily available within the prescription department of a pharmacy. The pharmacy shall maintain access to current and appropriate reference materials pertinent to the pharmacy practice, including but not limited to, veterinary pharmacy.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 23:1310 (October 1997), amended LR 29:2087 (October 2003), effective January 1, 2004, LR 39:315 (February 2013), amended by the Department of Health, Board of Pharmacy, LR 46:579 (April 2020), LR 47:1642 (November 2021).

§1105. Pharmacist-in-Charge

A. - H. ...

I. Change of Pharmacist-in-Charge. Written notice to the board shall be required when the pharmacist-in-charge designation for a pharmacy has changed.

1. The permit holder shall notify the board within 30 days of the prior pharmacist-in-charge's departure date. The permit holder shall designate a new pharmacist-in-charge within 10 days of the departure of the prior pharmacist-incharge.

2. The new pharmacist-in-charge shall afford the board written notice of his newly designated pharmacist-incharge status within 30 days of the departure of the prior pharmacist-in-charge.

3. A pharmacist-in-charge who voluntarily leaves a pharmacy shall give written notice to the board and the owner of the permit at least 10 days prior to the voluntary departure, unless replaced in a shorter period of time.

J. - K. ...

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 23:1310 (October 1997), amended LR 29:2088 (October 2003), effective January 1, 2004, LR 38:1239 (May 2012), amended by the Department of Health, Board of Pharmacy, LR 46:579 (April 2020), LR 47:1643 (November 2021).

§1107. Pharmacy Operation

A. - B. ...

C. No person credentialed by the board shall be required to engage in the practice of pharmacy for a period of time longer than six hours without a rest break.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 23:1310 (October 1997), amended LR 29:2088 (October 2003), effective January 1, 2004, amended LR 34:1408 (July 2008), amended by the Department of Health, Board of Pharmacy, LR 47:1643 (November 2021).

Subchapter B. Pharmacy Records

§1123. Records

A. - A.4. ...

B. A pharmacy may use one of the following types of pharmacy information systems.

1. A system that utilizes the original hard copy prescription or chart order to document the initial dispensing, but utilizes a computerized system to dispense refills that does not document the positive identification of the pharmacist responsible for the practice of pharmacy. In order to document positive identification, this system shall require the manual signature or initials of a pharmacist on a hard copy record as specified in Subsection E of this Section.

B.2. - J.4. ...

5. The prescription is not for a controlled dangerous substance.

K. - K.1. ...

2. For those pharmacies utilizing an electronic imaging system as described in Subsection J of this Section, written prescription drug order forms may be disposed of in a manner which protects the confidentiality of protected health information.

K.3. - L.1.c. ...

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 23:1312 (October 1997), amended LR 29:2090 (October 2003), effective January 1, 2004, LR 36:755 (April 2010), LR 40:2253 (November 2014), effective January 1, 2015, amended by the Department of Health, Board of Pharmacy, LR 46:580 (April 2020), LR 47:1643 (November 2021).

Subchapter C. Pharmacy Opening, Closing, Change of

Ownership, and Change of Location

Procedures

§1131. Pharmacy Opening Procedures

A. The board has established the following procedures as a prerequisite to the opening of any pharmacy:

1. Application Form. The applicant shall obtain the appropriate application form(s) from the board. The completed form(s) shall be signed by the pharmacist-incharge and returned to the board office, with appropriate fees, not less than 30 days prior to the anticipated opening of the pharmacy.

2. - 3. ...

4. repealed

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 29:2091 (October 2003), effective January 1, 2004, amended by the Department of Health, Board of Pharmacy, LR 47:1643 (November 2021).

Chapter 24. Limited Service Providers

Subchapter C. Telepharmacy Services

§2425. Telepharmacy Dispensing Site

A. - C.2. ...

D. Closure of Permit

1. When the owner of the permit intends to close the telepharmacy dispensing site permanently, the owner's managing officer and the pharmacist-in-charge shall be accountable to the board for the proper closure of the pharmacy in compliance with §1133 of this Part.

2. ...

E. Standards of Practice

1. Environmental Standards a. The prescription department shall consist of sufficient space commensurate with the nature and scope of the pharmacy's practice; this space shall be restricted to authorized personnel only and not accessible to the general public.

b. - g. ...

2. Minimum Staffing Requirements a. The pharmacist-in-charge of the supervising central pharmacy shall be the pharmacist-in-charge of the telepharmacy dispensing site, and this requirement shall operate as an exception to the contrary provisions of §1105 of this Part. However, the pharmacist-in-charge shall comply with the remaining provisions of §1105 of this Part.

b. - c. ...

d. A pharmacy intern or pharmacy technician candidate may not practice at a telepharmacy dispensing site.

e. ...

3. Operational Standards a. The telepharmacy dispensing site shall comply with the provisions of Chapters 11, 25, 27 and 29 of this Part except when this Subchapter grants exceptions or imposes more stringent requirements.

E.3.b. - E.3.f. ...

g. A pharmacist shall comply with the rules for drug utilization review and patient counseling in Chapter 5 of this Part, using HIPAA compliant technology in the telepharmacy system. E.3.h. - E.4.d. ...

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 21:2149 (October 2015), amended by the Department of Health, Board of Pharmacy, LR 46:586 (April 2020), LR 47:1643 (November 2021).

Chapter 25. Prescriptions, Drugs, and Devices

Subchapter B. Prescriptions

§2511. Prescriptions and Chart Orders

A. - B. ...

C. Written Prescriptions. A written prescription shall conform to the following format:

1. - 4. ...

5. Receipt via Facsimile a. Pharmacies may elect to receive written prescriptions via a facsimile machine located within the prescription department. The paper used to print such prescriptions shall produce a non-fading image. The pharmacy may elect to scan such documents in compliance with the provisions of §1123 of this Part.

b. Pharmacies may elect to receive written prescriptions via electronic facsimile directly within their pharmacy information system. The pharmacy shall retain such records in compliance with §1123 of this Part.

c. Repealed.

d. Repealed.

C.6. - F.3.d. ...

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2102 (October 2003), effective January 1, 2004, LR 41:98 (January 2015), LR 41:2147 (October 2015), amended by the Department of Health, Board of Pharmacy, LR 43:2162 (November 2017), LR 46:585 (April 2020), LR 47:1644 (November 2021).

§2513. Prescription Receipt and Verification of Prescription Drug Orders and Chart Orders

A. The receiving pharmacist is responsible for verification of the authenticity of the prescription.

B. The dispensing pharmacist is responsible for the accuracy of the medications or devices dispensed.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2103 (October 2003), effective January 1, 2004, amended by the Department of Health, Board of Pharmacy, LR 47:1644 (November 2021).

§2519. Prescription Refills; Medication Synchronization and Refill Consolidation

A. - B. ...

C. Controlled Dangerous Substances

1. ...

2. A prescription for a drug listed in Schedule III or IV may be refilled up to five times, if so indicated at the time issued.

3. A prescription for a drug listed in Schedule V may be refilled if so indicated at the time issued subject to the one-year expiration date of the prescription.

D. Medication Synchronization and Refill Consolidation.

These terms refer to a service which a pharmacist may perform for his patient, at the request of the patient, wherein he may proactively adjust the medication dispensing quantity and/or the refill schedule of a prescription in order to manage the patient's medication therapy, with the goal of improved medication adherence by the patient.

1. ...

2. With respect to prescriptions for controlled substances where refills have been authorized, pharmacists may utilize partial fills, as described in §2747.C.5 of this Part, but may not exceed the dispensing quantity noted on the original prescription.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2104 (October 2003), effective January 1, 2004, LR 33:1133 (June 2007), amended by the Department of Health, Board of Pharmacy, LR 42:1519 (September 2016), LR 46:575 (April 2020), LR 47:1644 (November 2021).

§2521. Emergency Refills

A. Using sound professional judgment, a pharmacist may refill adequate medication for a quantity not to exceed a 30- day supply when an emergency for medication has been adequately demonstrated and the prescribing practitioner is not available. The 30-day supply limitation shall not apply to multiple-dose unit-of-use containers.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2104 (October 2003), effective January 1, 2004, amended by the Department of Health, Board of Pharmacy, LR 47:1644 (November 2021).

§2525. Prescription Expiration

A. A prescription for a drug other than a controlled dangerous substance listed in Schedules II through IV shall expire one year after the date written.

B. A prescription for a controlled dangerous substance shall expire:

1. ...

2. six months after the date of issue if the drug is listed in Schedule III or IV.

C. ...

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2104 (October 2003), effective January 1, 2004, amended by the Department of Health, Board of Pharmacy, LR 42:1090 (July 2016), amended LR 47:1645 (November 2021).

Chapter 27. Controlled Dangerous Substances

Subchapter F. Production, Distribution and Utilization

§2745. Prescriptions

A. - G.1.e. ...

2. Expiration Date of Prescriptions a. A prescription for a controlled substance listed in Schedule III or IV shall expire six months after the date of issue, or following the acquisition of the number of refills authorized by the prescriber on the original prescription, whichever shall first occur.

b. A prescription for a controlled substance listed in Schedule V shall expire one year after the date of issue, or following the acquisition of the number of refills authorized by the prescriber on the original prescription, whichever shall first occur.

c. No pharmacist shall dispense any controlled substances pursuant to an expired prescription.

3. Refilling of Prescriptions a. The prescriber may authorize the refilling of a prescription for a controlled substance listed in Schedule III or IV by including specific refill instructions on the prescription prior to its issuance. The maximum number of refills the prescriber may authorize is five.

b. The prescriber may authorize the refilling of a prescription for a controlled substance listed in Schedule V by including specific refill instructions on the prescription prior to its issuance. There is no limitation on the number of refills the prescriber may authorize, subject however to the one year expiration date of the prescription.

c. In the absence of specific refill instructions on the original prescription from the prescriber, the prescription shall not be refilled.

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:972.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2149 (October 2008), amended LR 41:685 (April 2015), amended by the Department of Health, Board of Pharmacy, LR 42:1090 (July 2016), amended LR 47:1645 (November 2021).

§2747. Dispensing Requirements

A. - C.2.c. ...

3. Expiration Date a. A prescription for a controlled substance listed in Schedule III or IV shall expire six months after the date of issue, or following the acquisition of the number of refills authorized by the prescriber on the original prescription, whichever shall first occur.

b. A prescription for a controlled substance listed in Schedule V shall expire one year after the date of issue, or following the acquisition of the number of refills authorized by the prescriber on the original prescription, whichever shall first occur.

c. No pharmacist shall dispense any controlled substance pursuant to an expired prescription.

4. Refilling of Prescriptions a. No prescription for a controlled substance listed in Schedule III or IV shall be filled or refilled more than six months after the date on which such prescription was issued and no such prescription authorized to be refilled may be refilled more than five times. No prescription for a controlled substance listed in Schedule V shall be filled or refilled more than one year after the date on which such prescription was issued.

b. - c.v. ...

5. Partial Filling of Prescriptions. The partial filling of a prescription for a controlled substance listed in Schedule III, IV, or V is permissible, provided that:

a. - b.ii. ...

c. no dispensing shall occur more than six months after the date on which the prescription for a controlled substance listed in Schedule III or IV was issued, or more than one year after the date on which a prescription for a controlled substance listed in Schedule V was issued.

6. Labeling of Medications and Filing of Prescriptions a. -d. ...

e. All prescription forms shall be maintained in accordance with the requirements of Paragraph 2731.B.7 of this Chapter.

C.7. - C.8.a.i. ...

ii. ensure that all information required to be on a prescription pursuant to Subsection 2745.C of this Chapter is transmitted to the central fill pharmacy (either on the face of the prescription or in the electronic transmission of information);

C.8.a.iii. - D.4. ...

5. a bound record book for dispensing of controlled substances under this Paragraph is maintained by the pharmacist, which book shall contain the name and address of the purchaser, the name and quantity of controlled substance purchased, the date of each purchase, and the name or initials of the pharmacist who dispensed the controlled substance to the purchaser; further the book shall be maintained in conformance with the recordkeeping requirements identified in Paragraph 2731.B.7 of this Chapter; D.6. - F. ...

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:972.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2152 (October 2008), LR 41:685 (April 2015), amended by the Department of Health, Board of Pharmacy, LR 46:577 (April 2020), LR 47:1645 (November 2021).