La. Admin. Code tit. 46 § LIII-2747

Current through Register Vol. 50, No. 11, November 20, 2024

Section LIII-2747 - Dispensing Requirements

A. Location of Dispensing Activities. A pharmacist may dispense a prescription for a controlled substance pursuant to a valid prescription or order while in the usual course of his professional practice, but only within a prescription department in a pharmacy licensed by the board. A valid prescription or order is a prescription or order issued for a legitimate medical purpose by a practitioner authorized by law while acting in the usual course of his professional practice.

B. Prescriptions for Controlled Substances Listed in Schedule II

1. Oral Prescriptions. A pharmacist may accept and dispense an oral prescription from a prescribing practitioner, but only under the conditions described in, and in conformance with the requirements of, §2745. F.1.f of this Chapter.

2. Prescriptions Received by Facsimile Equipment

a. The facsimile equipment designated for the receipt of prescriptions shall be located within a prescription department in a pharmacy. The paper or other media used in the facsimile equipment designated for the receipt of prescriptions shall be non-fading and technically capable of providing a legible prescription.

b. A pharmacist shall not dispense a prescription based solely on a copy of the prescription received by facsimile, except under the circumstances described in §2745. F.1.b i, ii or iii.

c. In the event the facsimile transmission does not clearly identify the prescriber's office or other authorized location as the point of origin of the transmission, the pharmacist shall verify the authenticity of the prescription prior to dispensing the controlled substance.

3. Expiration Date. A pharmacist shall not dispense a prescription for a controlled substance listed in schedule II more than 90 days after the date of issue of the prescription.

4. Completion of Prescription Form. In the event a pharmacist receives a prescription for a controlled substance listed in Schedule II lacking certain required information, the pharmacist may consult with the prescriber (but not the prescriber's agent) to clarify the prescriber's intent. Following a consultation with the prescriber and the appropriate documentation thereof on the prescription form:

a. a pharmacist may record changes to the following data elements on the prescription form:

i. patient's address;

ii. drug strength;

iii. quantity prescribed; or

iv. directions for use;

b. a pharmacist may add the following data elements on the prescription form:

i. patient's address;

ii. drug dosage form; or

iii. prescriber's DEA registration number; however

c. a pharmacist shall never make changes to or add the following data elements on the prescription form:

i. patient's name;

ii. date of issue;

iii. drug name (except for generic interchange as permitted by law); or

iv. prescriber signature.

5. Partial Filling of Prescription

a. The partial filling of a prescription for a controlled substance listed in Schedule II is permissible with the following limitations:

i. When the pharmacist is unable to supply the full quantity called for in a written (or emergency oral) prescription, he shall make a notation of the quantity supplied on the face of the written prescription (or written record of the emergency oral prescription). The remaining portion of the prescription may be dispensed within 72 hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall notify the prescriber. No further quantity shall be dispensed beyond 72 hours without a new prescription.

ii. When a partial fill is requested by the patient or the prescriber, the pharmacist shall dispense a quantity less than the total quantity prescribed. The total quantity dispensed in all partial fillings shall not exceed the total quantity prescribed. No remaining portion of a partial filling may be dispensed more than 30 days after the date on which the prescription was written. The requirement for a pharmacist to comply with a patient or prescriber request to dispense a partial fill shall not supersede the pharmacist's obligation relative to corresponding responsibility as described in Subsection E of this Section.

b. A prescription for a controlled substance listed in Schedule II written for a patient in a long term care facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness may be filled in partial quantities to include individual dosage units. If there is any question whether a patient may be classified as having a terminal illness, the pharmacist shall contact the prescriber prior to partially filling the prescription. Both the pharmacist and the prescriber have a responsibility to assure that the controlled substance is for a terminally ill patient.

i. The pharmacist shall record on the prescription form whether the patient is "terminally ill" or an "LTCF patient." A prescription that is partially filled and does not contain the notation "terminally ill" or "LTCF patient" shall be deemed to have been filled in violation of these controlled substance rules.

ii. For each partial filling, the dispensing pharmacist shall record on the back of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable) the date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist.

iii. The total quantity dispensed in all partial fillings shall not exceed the total quantity prescribed.

iv. Notwithstanding the requirements of §2745. F 2, prescriptions for patients with a medical diagnosis documenting a terminal illness or for patients in a LTCF shall be valid for a period of time not to exceed 60 days from the date of issue unless terminated sooner by the discontinuance of the medication.

c. Information pertaining to current prescriptions for controlled substances listed in Schedule II for patients in a LTCF or for patients with a medical diagnosis documenting a terminal illness may be maintained in a computerized system if this system has the capability to permit:

i. output (display or printout) of the original prescription number, date of issue, identification of prescribing practitioner, identification of patient, address of the LTCF or address of the hospital or residence of the patient, identification of the medication authorized (to include dosage, form, strength and quantity), listing of the partial fillings that have been dispensed under each prescription, and the information required in §2747.A.5 b;

ii. immediate (real time) updating of the prescription record each time a partial filling of the prescription is conducted;

iii. retrieval of partially filled prescription information.

6. Refills. A pharmacist shall not refill a prescription for a controlled substance listed in Schedule II.

7. Labeling of Dispensed Medication and Filing of Prescription

a. The pharmacist dispensing a written or emergency oral prescription for a controlled substance listed in Schedule II shall affix to the package a dispensing label containing the following data elements:

i. name, address and telephone number of the pharmacy;

ii. prescription number;

iii. date of dispensing;

iv. prescribing practitioner's name;

v. patient's name;

vi. drug name and strength;

vii. directions for use;

viii. pharmacist's name or initials;

ix. the following warning statement: "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed", provided however, that this statement shall not be required to appear on the label of a controlled substance dispensed for use in clinical investigations which are "blind";

x. other cautionary or auxiliary labels as applicable.

b. If the prescription is dispensed at a central fill pharmacy, the pharmacist at the central fill pharmacy shall affix to the package a label showing the name and address of the retail pharmacy and a unique identifier (i.e., the central fill pharmacy's DEA registration number) indicating the prescription was filled at the central fill pharmacy, as well as the data elements itemized above in Subsection B.7.a.

c. The requirements of Subsection B.7.a shall not apply when a controlled substance listed in Schedule II is prescribed for administration to an ultimate user who is institutionalized, provided that:

i. no more than a seven-day supply of the medication is dispensed at one time;

ii. the medication is not in the possession of the ultimate user prior to the administration;

iii. the institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of controlled substances listed in Schedule II; and

iv. the system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product, and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law.

d. After dispensing a prescription for a controlled substance listed in Schedule II, the pharmacist shall cancel the prescription by defacing the prescription form and recording his name or initials on the form.

e. All written prescriptions and written records of emergency oral prescriptions shall be maintained in accordance with the requirements of §2731. B 7

8. Provision of Prescription Information between Retail Pharmacies and Central Fill Pharmacies. Prescription information may be provided to an authorized central fill pharmacy by a retail pharmacy for dispensing purposes. The following requirements shall apply.

a. Prescriptions for controlled substances listed in Schedule II may be transmitted electronically from a retail pharmacy to a central fill pharmacy, including via facsimile. The retail pharmacy transmitting the prescription information shall:

i. record the words "CENTRAL FILL" on the face of the original prescription and record the name, address and DEA registration number of the central fill pharmacy to which the prescription has been transmitted, the name of the retail pharmacy pharmacist transmitting the prescription, and the date of transmittal;

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

iii. maintain the original prescription for a period of two years from the date the prescription was filled;

iv. keep a record of receipt of the filled prescription, including the date of receipt, the method of delivery (private, common or contract carrier) and the name of the retail pharmacy employee accepting delivery.

b. The central fill pharmacy receiving the transmitted prescription shall:

i. keep a copy of the prescription (if sent via facsimile) or an electronic record of all the information transmitted by the retail pharmacy, including the name, address and DEA registration number of the retail pharmacy transmitting the prescription;

ii. keep a record of the date of receipt of the transmitted prescription, the name of the pharmacist dispensing the prescription, and the date of dispensing of the prescription;

iii. keep a record of the date the dispensed prescription was delivered to the retail pharmacy and the method of delivery (private, common or contract carrier).

C. Prescriptions for Controlled Substances Listed in Schedule III, IV, or V

1. Oral Prescriptions. Upon the receipt of an oral prescription from a prescriber or his agent, the pharmacist shall immediately reduce the prescription information to written form. The pharmacist may then dispense the prescription and file the written record in his prescription files.

2. Prescriptions Received by Facsimile Equipment

b. The facsimile may serve as the original prescription form. After dispensing the prescription, the pharmacist shall file the facsimile prescription form in his prescription files.

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. Each refilling of a prescription shall be entered on the back of the prescription or on another appropriate document. If entered on another document, such as a medication record, the document shall be uniformly maintained and readily retrievable. The following information shall be retrievable by the prescription number: name and dosage form of the controlled substance, the date filled or refilled, the quantity dispensed, initials of the dispensing pharmacist for each refill, and the total number of refills for that prescription. If the pharmacist merely initials and dates the back of the prescription, it shall be deemed that the full face amount of the prescription has been dispensed.

c. As an alternative to the procedures described in Subparagraph C.4.b of this Section, an automated data processing system may be used for the storage and retrieval of refill information for prescription orders for controlled substances in Schedule III, IV, and V, subject to the following conditions.

i. Any such proposed computerized system must provide on-line retrieval (via CRT display or hard-copy printout) of original prescription order information for those prescription orders which are currently authorized for refilling. This shall include, but is not limited to, data such as the original prescription number, date of issuance of the original prescription order by the practitioner, full name and address of the patient, name, address, and DEA registration number of the practitioner, and the name, strength, dosage form, and quantity of the controlled substance prescribed (and quantity dispensed if different from the quantity prescribed), and the total number of refills authorized by the prescribing practitioner.

ii. Any such proposed computerized system must also provide on-line retrieval (via CRT display or hard-copy printout) of the current refill history for Schedule III, IV, or V controlled substance prescription orders (those authorized for refill during the past six months). This refill history shall include, but is not limited to, the name of the controlled substance, the date of refill, the quantity dispensed, the identification code, or name or initials of the dispensing pharmacist for each refill and the total number of refills dispensed to date for that prescription order.

iii. Documentation of the fact that the refill information entered into the computer each time a pharmacist refills an original prescription order for a Schedule III, IV, or V controlled substance is correct must be provided by the individual pharmacist who makes use of such a system. If such a system provides a hard-copy printout of each day's controlled substance orders refill data, that printout shall be verified, dated, and signed by the individual pharmacist who refilled such a prescription order. The individual pharmacist shall verify that the data indicated is correct and then sign this document. This document shall be maintained in a separate file at that pharmacy for a period of two years from the dispensing date. This printout of the day's controlled substance prescription order refill data shall be provided to each pharmacy using such a computerized system within 72 hours of the date on which the refill was dispensed. The printout shall be verified and signed by each pharmacist who is involved with such dispensing. In lieu of such a printout, the pharmacy shall maintain a bound logbook, or separate file, in which each individual pharmacist involved in such dispensing shall sign a statement (in the manner previously described) each day, attesting to the fact that the refill information entered into the computer that day has been reviewed by him and is correct as shown. Such a book or file shall be maintained at the pharmacy employing such a system for a period of two years after the date of dispensing the appropriately authorized refill.

iv. Any such computerized system shall have the capability of producing a printout of any refill data which the user pharmacy is responsible for maintaining. For example, this would include a refill-by-refill audit trail for any specified strength and dosage form of any controlled substance (by either brand or generic name, or both). Such a printout shall include the name of the prescribing practitioner, name and address of the patient, quantity dispensed on each refill, date of dispensing for each refill, name or identification code of the dispensing pharmacist, and the prescription number. In any computerized system employed by a user pharmacy, the central recordkeeping location must be capable of sending the printout to the pharmacy within 48 hours. If the board or an agent of the board requests a copy of such printout from the user pharmacy, the pharmacy shall verify the printout transmittal capability of its system by documentation, e.g., postmark.

v. In the event that a pharmacy which employs such a computerized system experiences system down-time, the pharmacy shall have an auxiliary procedure which will be used for documentation of refills on prescriptions for controlled substances listed in Schedule III, IV, or V. This auxiliary procedure shall insure that refills are authorized by the original prescription order, that the maximum number of refills has not been exceeded, and that all of the appropriate data is retained for on-line data entry as soon as the computer system is available for use again.

5. Partial Filling of Prescriptions. When requested by the patient or prescriber, the pharmacist shall dispense a partial fill of a controlled substance listed in Schedules III, IV or V, provided that:

a. the information required for a partial filling, and the manner in which it is recorded, is the same as that required for a refill;

b. the number of partial fillings is not limited; however, the total quantity dispensed in all partial fillings shall not exceed the total quantity authorized on the original prescription. The total quantity authorized may be calculated as the sum of:

i. the quantity prescribed, and

ii. the calculated amount of the quantity prescribed times the number of refills originally authorized by the prescriber;

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 the prescription for a controlled substance listed in Schedule V was issued; and

d. the requirement for a pharmacist to comply with a patient or prescriber request to dispense a partial fill shall not supersede the pharmacist's obligation relative to corresponding responsibility as described in Subsection E of this Section.

6. Labeling of Medications and Filing of Prescriptions

a. The pharmacist dispensing a prescription for a controlled substance listed in Schedule III, IV, or V shall affix to the package a dispensing label containing the following data elements:

i. name, address and telephone number of the pharmacy;

ii. prescription number;

iii. date of dispensing;

iv. prescribing practitioner's name;

v. patient's name;

vi. drug name and strength;

vii. directions for use;

viii. pharmacist's name or initials;

ix. for controlled substances listed in Schedules III or IV, the following warning statement: "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed", provided however, that this statement shall not be required to appear on the label of a controlled substance dispensed for use in clinical investigations which are "blind";

x. other cautionary or auxiliary labels as applicable.

c. The requirements of Subparagraph C.6.a of this Section shall not apply when a controlled substance listed in Schedule III, IV, or V is prescribed for administration to an ultimate user who is institutionalized, provided that:

i. no more than a 34-day supply, or 100 dosage units, whichever is less, is dispensed at one time;

ii. the medication is not in the possession of the ultimate user prior to the administration;

iii. the institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of controlled substances listed in Schedule III, IV, and V; and

d. After dispensing an original prescription for a controlled substance listed in Schedule III, IV, or V, the pharmacist shall record his name or initials on the form.

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

7. Transfer between pharmacies of prescription information for Schedule III, IV, or V for refill purposes

a. The transfer of prescription information for a controlled substance listed in Schedule III, IV, or V for the purpose of refill dispensing is permissible between pharmacies on a one time basis only. However, pharmacies electronically sharing a real-time, on-line database may transfer up to the maximum refills permitted by law and the prescriber's authorization, whether or not the pharmacy from which the prescription is transferred is open for business. Transfers are subject to the following requirements.

i. The transfer is communicated directly between two licensed pharmacists and the transferring pharmacist records the following information:

(a). invalidation of the prescription;

(b). on the reverse of the invalidated prescription, the name, address, and DEA registration number of the pharmacy to which it was transferred, and the name of the pharmacist receiving the prescription information;

(c). the date of the transfer and the name of the pharmacist transferring the information.

ii. The pharmacist receiving the transferred prescription information shall reduce to writing the following:

(a). indication of the transferred nature of the prescription;

(b). provide all information required for a prescription for a controlled substance (full name and address of the patient; drug name, strength, and dosage form; quantity prescribed and directions for use; and the name, address, telephone number, and DEA registration number of the prescribing practitioner) and include:

(i). date of issuance of original prescription;

(ii). original number of refills authorized on original prescription;

(iii). date of original dispensing;

(iv). number of valid refills remaining and date(s) and locations of previous refill(s);

(v). pharmacy's name, address, and DEA registration number and prescription number from which the prescription information was transferred;

(vi). name of pharmacist who transferred the prescription; and

(vii). pharmacy's name, address, and DEA registration number and prescription number from which the prescription was originally filled.

iii. The original and transferred prescription(s) shall be maintained for a period of two years from the date of the last refill.

iv. Pharmacies electronically accessing the same prescription record shall satisfy all information requirements of a manual mode for prescription transferal.

a. Prescriptions for controlled substances listed in Schedule III, IV, or V may be transmitted electronically from a retail pharmacy to a central fill pharmacy, including via facsimile. The retail pharmacy transmitting the prescription information shall:

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);

iii. indicate in the information transmittal the number of refills already dispensed and the number of refills remaining;

iv. maintain the original prescription for a period of two years from the date the prescription was last refilled;

v. keep a record of receipt of the filled prescription, including the date of receipt, the method of delivery (private, common or contract carrier) and the name of the retail pharmacy employee accepting delivery.

b. The central fill pharmacy receiving the transmitted prescription shall:

ii. keep a record of the date of receipt of the transmitted prescription, the name of the pharmacist dispensing the prescription, and the dates of filling or refilling of the prescription;

iii. keep a record of the date the dispensed prescription was delivered to the retail pharmacy and the method of delivery (private, common or contract carrier).

D. Dispensing Controlled Substances without a Prescription. A controlled substance listed in Schedule II, III, IV, or V which is not a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act may be dispensed by a pharmacist without a prescription to a purchaser at retail, provided that:

1. such dispensing is made only by a pharmacist, and not by a non-pharmacist employee even if under the supervision of a pharmacist, although after the pharmacist has fulfilled his professional and legal responsibilities, the actual cash, credit transaction, or delivery may be completed by a non-pharmacist;

2. not more than 240 milliliters, or 8 ounces, of any such controlled substance containing opium, nor more than 120 milliliters, or 4 ounces, of any other such controlled substance, nor more than 48 dosage units of any such controlled substance containing opium, nor more than 24 dosage units of any other such controlled substance may be dispensed at retail to the same purchaser in any given 48-hour period;

3. the purchaser is at least 18 years of age;

4. the pharmacist requires every purchaser of a controlled substance under this paragraph not known to him to furnish suitable identification (including proof of age where appropriate);

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;

6. a prescription is not required for dispensing of the controlled substance pursuant to any federal or state law;

7. central fill pharmacies may not dispense controlled substances to a purchaser at retail pursuant to this Paragraph.

E. Professional Conduct. A license, registration, certification, permit, or any other credential deemed necessary to practice, or assist in the practice of, pharmacy may be subject to discipline when deviating from primary or corresponding responsibility to avert the following prohibited acts.

1. Primary responsibility:

a. drug diversion-attempted, actual or conspired dispensing, distributing, administering, or manufacturing of a controlled substance not pursuant to a valid prescription or order while acting in the course of professional pharmacy practice is prohibited; or

b. possession-actual or conspired possession of a controlled substance not pursuant to a valid prescription or order issued for a legitimate medical purpose by an authorized practitioner in the usual course of professional practice.

2. Corresponding Responsibility

a. Medical Purpose. The prescribing practitioner has the primary responsibility to issue a prescription for a controlled substance for a legitimate medical purpose, but a corresponding responsibility rests with the pharmacist or dispensing physician dispensing said prescription to ascertain that said prescription was issued for a legitimate medical purpose in the usual course of professional practice.

b. Authenticity. A pharmacist or dispensing physician shall exercise sound professional judgment to ascertain the validity of prescriptions for controlled substances. If, in the pharmacist's professional judgment, a prescription is not valid, said prescription shall not be dispensed.

3. Forged Prescriptions. It is unlawful to forge a prescription, or to dispense a forged prescription, for a controlled substance. The pharmacist or dispensing physician shall exercise professional diligence in determining the validity of a prescription as to the practitioner's authority and/or patient's identity, in order to prevent misrepresentation, fraud, deception, subterfuge, conspiracy, or diversion of controlled substances.

4. Altered Prescriptions. It is unlawful to personally alter a prescription, or to dispense an altered prescription, for a controlled substance, except as provided by §2747.B.4 of this Chapter.

F. Accountability. The pharmacist-in-charge, the owner of a pharmacy permit, and/or other designated responsible parties, shall be accountable for shortages of controlled substances or inconsistencies indicated in an audit.

La. Admin. Code tit. 46, § LIII-2747

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2152 (October 2008), Amended by LR 41685 (4/1/2015), Amended by the Department of Health, Board of Pharmacy, LR 46577 (4/1/2020), Amended LR 471645 (11/1/2021), Amended LR 49681 (4/1/2023).

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