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. The partial filling of a prescription for a controlled substance listed in Schedule III, IV, or V is permissible, provided that:
a.the information (and the manner in which it is recorded) for a partial filling 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 was issued.
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;
iii.date of dispensing;
iv.prescribing practitioner'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.
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 Subparagraph C.6.a of this Section.
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
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 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 §2731.B.7.
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.
Louisiana Register Vol. 34, No. 10 October 20, 2008