105 CMR, § 721.010
The terms used in 105 CMR 721.000 shall have the meanings set forth in 105 CMR 721.010. Terms defined in M.G.L. c. 112, § 12D and M.G.L. c. 94C, § 1 and 105 CMR 700.001: Definitions, and not defined in 105 CMR 721.010 shall have the meanings set forth therein when used in 105 CMR 721.000, unless the context clearly requires a different interpretation.
Authentication means that the identities of the parties sending and receiving Electronic Prescription data are duly verified.
Commissioner means the Commissioner of the Massachusetts Department of Public Health or his or her designee.
Compounded Drug Preparation means a preparation created through mixing, assembling, altering, packaging, and labeling of a controlled substance as the result of a practitioner's order or in anticipation of such an order based on routine, regularly observed prescribing patterns. A Compounded Drug Preparation shall not include the reconstitution of pre-measured, commercially available controlled substances.
Department means the Massachusetts Department of Public Health.
Drug Product means the final dosage form of a drug that is marketed under a brand or generic name.
Electronic Prescribing System means an Electronic Prescribing System that meets federal requirements for Electronic Prescriptions for controlled substances, including the validation and Authentication requirements pursuant to 21 CFR 1311 Subpart C: Electronic Prescriptions for generation of Electronic Prescriptions for controlled substances. Electronic Prescribing Systems may be stand-alone systems, where the sole purpose for the system is the generation and transmission of Electronic Prescriptions, or part of a more comprehensive healthcare system such as an electronic health record.
Electronic Prescription means a Prescription which is generated on an Electronic Prescribing System and sent by Electronic Transmission to a pharmacy without alteration of the Prescription information. As used in 105 CMR 721.000, Electronic Prescription does not include an order for medication which is dispensed for immediate administration to the ultimate user.
Electronic Signature means an electronic sound, symbol or process attached to or logically associated with a Prescription record and executed or adopted by a practitioner with the intent to sign said Prescription record and which is validated and authenticated in accordance with M.G.L. c. 110G and 21 CFR 1311 Subpart C: Electronic Prescriptions and other federal regulations applicable to Electronic Signatures generated through Electronic Prescribing Systems.
Electronic Transmission means that the record is seamlessly generated, transmitted and received on systems which are validated and authenticated in accordance with 21 CFR 1311 Subpart C: Electronic Prescriptions and other federal regulations applicable to Electronic Transmission of Prescriptions. The use of third-party intermediaries acting as conduits to route the Prescriptions from a prescriber to a pharmacy, where the systems of such third party intermediary meet the security requirements for Electronic Transmissions, are authorized under 105 CMR 721.000. Transmission by facsimile is not authorized as an Electronic Transmission.
Emergency Situation means
ePrescribing means generating a Prescription on an Electronic Prescribing System and sending by Electronic Transmission to a pharmacy without alteration of the Prescription information.
Failover means a document that originates as a schedule VI Electronic Prescription, but experiences an unforeseen defect, as outlined in Department guidance, during Electronic Transmission, and is converted to a computer generated facsimile.
Oral Prescription means an oral order for medication which is dispensed to or for an ultimate user, but not including an order for medication which is dispensed for immediate administration to the ultimate user.
Prescription means an oral, written or electronic order for a medication or device which is dispensed to or for an ultimate user. A Prescription does not mean an order for medication which is dispensed for immediate administration to the ultimate user.
Qualified Healthcare Professional means a physician, certified nurse practitioner, psychiatric nurse mental health clinical specialist or certified registered nurse anesthetist authorized to supervise prescriptive practice pursuant to M.G.L. c. 94C, § 80H and applicable regulations by the Board of Registration in Nursing.
Registration Number means the registration number assigned to a practitioner by the federal Drug Enforcement Agency authorizing them to generate Prescriptions for controlled substances. Practitioners who do not have a DEA Registration Number, as they prescribe only from schedule VI, shall use their Massachusetts Controlled Substance Registration number.
Written Prescription means a lawful paper-based order from a practitioner for a drug or device for a specific patient that is communicated directly to a pharmacist in a licensed pharmacy; provided, however, that "Written Prescription'' shall not include an order for medication which is dispensed for immediate administration to the ultimate user.
105 CMR, § 721.010