Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter F - Production, Distribution, and Utilization › Section LIII-2747 - Dispensing Requirements

Current through Register Vol. 50, No. 6, June 20, 2024
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).