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Delaware News: Faxing of Controlled Substance Prescriptions
Published in the June 2006 Delaware State Board of Pharmacy Newsletter.
There have been a number of recent inquiries and some confusion regarding the validity of faxing controlled substance (CS) prescriptions from a practitioner’s office to a pharmacy. The faxing of CS prescriptions is permitted under the following federal and state law.
[CS] Regulation 4.2.3 states that written prescriptions for [CS] may be transmitted via facsimile by a practitioner or by the practitioner’s authorized agent to a pharmacy only when the transmission complies with 21 CFR 1306.11, 1306.21 and 1306.31.
1306.11 – A prescription for a Schedule II [CS] may be transmit¬ted by the practitioner or the practitioner’s agent to a pharmacy via facsimile equipment, provided that the original written, signed prescription is presented to the pharmacist for review prior to the actual dispensing of the [CS], except as noted in paragraph (e), (f), or (g) of this section. The original prescription shall be maintained in accordance with §1304.04(h) of this chapter. The facsimile serves as the original written prescription for purposes of:
Exception (e) A prescription prepared in accordance with [§]1306.5 written for a Schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion;
Exception (f) A prescription prepared in accordance with [§]1306.05 written for a Schedule II substance for a resident of a Long Term Care Facility may be transmitted by the practitioner or the practi¬tioner’s agent to the dispensing pharmacy by facsimile; and
Exception (g) A prescription prepared in accordance with [§]1306.5 written for a Schedule II narcotic substance for a patient enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII or a hospice program which is licensed by the state may be transmitted by the practitioner or the practitioner’s agent to the dispensing pharmacy by facsimile. The practitioner or the practitioner’s agent will note on the prescription that the patient is a hospice patient.
Pursuant to 1306.21 (a) A pharmacist may dispense directly a CS listed in Schedule III, IV, or V, which is a prescription drug as deter¬mined under the Federal Food, Drug, and Cosmetic Act, only pursuant to either a written prescription signed by a practitioner or a facsimile of a written, signed prescription transmitted by the practitioner or the practitioner’s agent to the pharmacy or pursuant to an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist containing all information required in §1306.5, except for the signature of the practitioner.
Additionally, according to the requirements of Delaware Pharmacy Regulation 5 all electronically transmitted prescriptions shall be transmitted directly to a pharmacist in a licensed pharmacy of the patient’s choice with no intervening person having access to the prescription drug order; identify the transmitter’s phone number for verbal confirmation, the time and date of transmission, and the identity of the pharmacy intended to receive the transmission, as well as any other information required by federal or state law; be transmitted by an authorized practitioner or his designated agent; and be deemed the original prescription drug order provided it meets the requirements of this subsection. The pharmacist shall exercise professional judgment regarding the accuracy, validity, and authenticity of the prescription drug order communicated by way of electronic transmission consistent with existing federal or state laws and rules. All electronic equipment for receipt of prescription drug orders communicated by way of electronic transmission shall be maintained so as to ensure against unauthorized access. Persons other than those bound by a confidentiality agreement pursuant to §2.A. (2)(k) shall not have access topharmacy records containing confidential information or personally identifiable information concerning the pharmacy’s patients.
CS prescriptions may only be electronically transmitted via a facsimile. Facsimile prescriptions must meet the following requirements in addition to the above listed electronic transmission requirements. The prescription order shall include the fax number of the transmitter, the number of transmitted pages, the name, phone number, and electronic number of the pharmacy intended to receive the transmission, and a confidentiality statement in bold type stating the electronic transmission should not be seen by unauthorized persons; unless the prescription is written for a schedule II CS, the prescriber should not issue the written prescription to the patient; a facsimile transmitted prescription order must be reduced to writing, unless received as a non-fading document, with a notation that the order was received by facsimile; the receiving facsimile machine must be in the prescription department to protect patient-pharmacist-authorized prescriber confidentiality and security; both non-controlled and CS prescriptions may be transmitted via facsimile following state and federal requirements. All prescription orders for CS shall be hand-signed by the practitioner.
For further specific federal and state code information, please see 21 CFR 1300 to the end and 24 Del. C. 2500 to the end, respectively.
