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Delaware News: Controlled Substance Issues Frequently Asked Questions
Published in the September 2008 Delaware State Board of Pharmacy Newsletter
Transfer of Controlled Substances between Pharmacies
21 CFR 1306.25
(a) The transfer of original prescription information for a controlled substance listed in Schedules III, IV, or V for refill dispensing is permissible between pharmacies on a one time basis only. Pharmacies electronically sharing a real-time, on-line database may transfer up to the maximum refills permitted by law and the prescriber’s authorization. Transfers are subject to the following requirements:
(1) The transfer is communicated directly between two licensed pharmacists and the transferring pharmacists records the following information:
(i) Write the word “VOID” on the face of the invalidated prescription.
(ii) Record 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.
(iii) Record the date of the transfer and the name of the pharmacist transferring the information.
(b) The receiving pharmacist shall reduce to writing the following:
(1) Write the word “transfer” on the face of the transferred prescription.
(2) Provide all information pursuant to 21 CFR 1306.05 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, DEA registration number and prescription number from which the prescription information was transferred;
(vi) Name of pharmacist who transferred the prescription.
(vii) Pharmacy’s name, address, DEA registration number and prescription number from which the prescription was originally filled. (3) The original and transferred prescription(s) must be maintained for a period of two years from the date of last refill.
Changes that can be made on a Controlled Substance Prescription
A number of changes can be made to a controlled substance prescrip¬tion only after the pharmacist contacts the prescribing practitioner. After prescriber consultation, the pharmacist is permitted to change the patient’s address, drug strength, drug quantity, and directions for use. The pharmacist is permitted to make information additions that may be provided by the patient or bearer such as the patient’s address, and such additions should be verified. The pharmacist may also add the dosage form to the prescription order after verification with the prescribing practitioner.
The pharmacist is never permitted to make changes to the patient’s name, controlled substance prescribed (except for generic substitution per¬mitted by state law), or the prescriber’s signature. These types of changes challenge the necessity of the original prescription and would require a new prescription from the prescribing practitioner.
Partial Filling of Schedule II Controlled Substances
21 CFR §1306.13: Partial Filling of Prescriptions allows for the partial filling of a Schedule II controlled substance, if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription. The pharmacist must 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 filled 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 prescribing individual practitioner. No further quantity may be supplied beyond the 72 hours without a new prescription.
Expiration of Controlled Substance Prescriptions
Prescriptions for controlled substances in Schedules II and III will be¬come void unless dispensed within seven (7) days of the original date of the prescription or if the original prescriber authorizes the prescription past the seven (7)-day period. Such prescriptions cannot be written or dispensed for more than 100 dosage units or a 31-day supply, whichever is the greater at one time. As an exception to dosage limitations set forth in this sub¬paragraph, and in accordance with 21 CFR §1306.1(b), prescriptions for controlled substances in Schedule II for patients either having a medically documented terminal illness or patients in long-term care facilities (LTCF), may be filled in partial quantities, to include individual dosage units. For each partial filling, the dispensing pharmacist shall record on the back of the prescription (or another appropriate record, uniformly maintained, and readily retrievable) the date of the partial filling, quantity dispensed, the dispensing pharmacist. The total quantity of Schedule II controlled substances dispensed in all partial fillings must not exceed the total quantity prescribed. Schedule II prescriptions for terminally ill or LTCF patients, shall be valid for a period not to exceed 60 days from the issue date unless sooner terminated by the discontinuance of the medication.
Multiple Schedule II Prescriptions with Different Dates
Multiple Schedule II prescription for the same patient with different dates are permitted. Prescriptions must be written with the date of issue, may not exceed 90 days, must be prescribed for a legitimate purpose and written by a licensed, registered practitioner acting in the usual course of professional practice.
