§1306.05. Manner of issuance of prescriptions. — Inbound Citations

(d) A prescription may be issued by a practitioner in accordance with § 1306.05 for a Schedule III, IV, or V controlled substance for the purpose of maintenance or detoxification treatment for the purposes of administration in accordance with section 309A of the Act (21 U.S.C. 829a) and § 1306.07(f). Such prescription shall not be used to supply any practitioner with a stock of controlled substances for the purpose of general dispensing to patients.

(d) If the content of any of the information required under § 1306.05 for a controlled substance prescription is altered during the transmission, the prescription is deemed to be invalid and the pharmacy may not dispense the controlled substance.

(2) The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information required in § 1306.05, except for the signature of the prescribing individual practitioner;

(3) Where a practitioner issues a prescription for a schedule II controlled substance and wants the prescription to be partially filled, the practitioner must specify the quantity to be dispensed in each partial filling on the face of the written prescription, in the written record of the emergency oral prescription, or in the record for an electronic prescription. After consultation with a pharmacist, a practitioner may authorize a partial fill for the prescription at a date after which the prescription was initially issued; however, the prescription must be filled not later than 30 days after the date on which the prescription is written, except that in the case of an emergency oral prescription, as described in subsection 309(a) of the Act (21 U.S.C. 829(a)), the remaining portions of a partially filled prescription for a schedule II controlled substance, if filled, must be filled not later than 72 hours after the prescription is issued. The pharmacist must notate this subsequent request in accordance with paragraph (b)(5) of this section. All required information in this paragraph, except that of an authorization for partial filling at a later date, must be included on the prescription, along with the other information required by § 1306.05, at the time the practitioner signs the prescription, or in the case of an emergency oral prescription, this information must be communicated by the prescribing practitioner to the pharmacist at the time that the oral communication is taking place.

(2) Ensure that all information required to be on a prescription pursuant to Section 1306.05 of this part is transmitted to the central fill pharmacy (either on the face of the prescription or in the electronic transmission of information);

(a) A pharmacist may dispense directly a controlled substance listed in Schedule III, IV, or V that is a prescription drug as determined under section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)) only pursuant to either a paper prescription signed by a practitioner, a facsimile of a signed paper prescription transmitted by the practitioner or the practitioner's agent to the pharmacy, an electronic prescription that meets the requirements of this part and part 1311 of this chapter, or an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist containing all information required in § 1306.05, except for the signature of the practitioner.

(3) For paper prescriptions and prescriptions received orally and reduced to writing by the pharmacist pursuant to § 1306.21(a), the pharmacist receiving the transferred prescription information must write the word “transfer” on the face of the transferred prescription and reduce to writing all information required to be on a prescription pursuant to § 1306.05 and include:

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

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

(2) Ensure that all information required to be on a prescription pursuant to § 1306.05 of this part is transmitted to the central fill pharmacy (either on the face of the prescription or in the electronic transmission of information);

(1) The information required for a prescription under § 1306.05(a) of this chapter.

(11) While the information required by paragraph (b)(9) of this section and the statement required by § 1311.140(a)(3) remain displayed, the electronic prescription application must prompt the prescribing practitioner to authenticate to the application, using two-factor authentication, as specified in § 1311.140(a)(4), which will constitute the signing of the prescription by the practitioner for purposes of § 1306.05(a) and (e) of this chapter.

(5) The completion by the practitioner of the two-factor authentication protocol in the manner provided in paragraph (a)(4) of this section will constitute the signing of the prescription by the practitioner for purposes of § 1306.05(a) and (e) of this chapter.

(1) Import, store, and display the information required for prescriptions under § 1306.05(a) of this chapter.

(9) The pharmacy application must read and store in full the information required under § 1306.05(a) of this chapter. The pharmacy application must either verify that such information is present or must display the information for the pharmacist's verification.

(1) If the information required in § 1306.05(a) of this chapter, the indication that the prescription was signed as required by § 1311.120(b)(17) or the digital signature created by the practitioner's private key, if transmitted, and the number of refills as required by § 1306.22 of this chapter, cannot be consistently and accurately recorded, stored, and transmitted, the third-party auditor or certification organization must indicate that the application does not meet the requirements of this part.

(11) While the information required by paragraph (b)(9) of this section and the statement required by § 1311.140(a)(3) remain displayed, the electronic prescription application must prompt the prescribing practitioner to authenticate to the application, using two-factor authentication, as specified in § 1311.140(a)(4), which will constitute the signing of the prescription by the practitioner for purposes of § 1306.05(a) and (e) of this chapter.

(5) The completion by the practitioner of the two-factor authentication protocol in the manner provided in paragraph (a)(4) of this section will constitute the signing of the prescription by the practitioner for purposes of § 1306.05(a) and (e) of this chapter.