Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 721.000 - Standards for Prescription Format and Security in Massachusetts › Section 721.010 - Definitions

Current through Register 1525, July 5, 2024
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
(1) situations in which the prescribing practitioner intends to
				prescribe a controlled substance, the immediate administration of which is
				necessary for the proper treatment of the intended ultimate user; and a. it is
				not reasonably possible for the prescribing practitioner to generate or
				transmit an Electronic Prescription to be presented to the person dispensing
				the controlled substance prior to the dispensing; or b. the prescribing
				practitioner determines that the Electronic Prescription requirement would
				result in a delay that would adversely impact the patient's medical condition;
				or
(2) any other Emergency Situation defined in Department
				guidance by the Commissioner, acting pursuant to M.G.L. c. 94C, § 17.
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.
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.