Mass. Gen. Laws ch. 94C, sec. 21 — MA Code / Part I / Title XV / Chapter 94C / Section 21
Packaging and labeling by pharmacist filling prescription; distribution of educational pamphlet
Status: in_force

Section 21. The pharmacist filling a written, electronic or oral prescription for a controlled substance shall package the controlled substance in a container, affixing to the container a label showing the date of filling, the pharmacy name and address, the filling pharmacist's initials, the serial number of the prescription, the name of the patient, unless it is a veterinary prescription, the name of the prescribing practitioner, the name of the controlled substance, directions for use and cautionary statements, if any, contained in such prescription or required by law, and if the controlled substance is dispensed as tablets or capsules the number of same in such container. Upon the request of an elderly person, as defined in section fourteen of chapter nineteen A or a person visually impaired, directions on the label affixed by the pharmacist to a container of a prescription drug shall be typed in a print size allowing no more than ten characters per inch. The department, in consultation with relevant stakeholders and experts in the treatment and management of acute and chronic pain, and based in part on the Pain Management Best Practices Inter–Agency Task Force Report issued by the United States Department of Health and Human Services, shall produce and distribute, either in written or electronic form, to pharmacies, not including institutional pharmacies, pamphlets for consumers relative to narcotic drugs, including opiates, that shall include educational information related to: (i) pain management and the use and availability of non-opioid alternatives for the treatment of acute and chronic pain, including, but not limited to: (A) information on available non-opioid alternatives for the treatment of pain, including non-opioid medications and non-pharmacological therapies; and (B) the advantages and disadvantages of the use of such non-opioid treatment alternatives; (ii) the consumer's option to fill a prescription for a schedule II controlled substance in a lesser quantity than indicated on the prescription pursuant to subsection (d|b5) of section 18; (iii) misuse and abuse of narcotics by adults and children; (iv) the risk of dependency and addiction associated with narcotics use; (v) proper storage and disposal of narcotics; (vi) addiction support and treatment resources; (vii) the telephone helpline operated by the bureau of substance addiction services established in section 18 of chapter 17; (viii) the risks of unintended overdoses associated with prescription opioid use, including, but not limited to: (A) mixing any opioid with stimulants or respiratory depressants, including, but not limited to, alcohol and benzodiazepines; and (B) changes in personal tolerance levels for persons with a history of overdose; and (ix) risk reduction measures to prevent, respond to and reverse an opioid overdose. A pharmacist shall distribute the pamphlet when dispensing a narcotic or controlled substance contained in schedule II or III; provided, however, that pharmacists shall not be required to distribute the pamphlet if: (1) the patient is receiving outpatient palliative care pursuant to section 227 of chapter 111; (2) the patient is a resident of a long-term care facility; or (3) the narcotic or controlled substance is prescribed for use in the treatment of substance use disorder or opioid dependence. For the purposes of this section, non-opioid treatment alternatives shall include, but shall not be limited to, medications, restorative therapies, interventional procedures, behavioral health approaches and complementary and integrative treatments. The labeling provisions of this section shall apply to the compounding and dispensing of drugs on the oral, electronic or written prescription of a licensed and registered prescriber under section 9. All drug preparations compounded, made or formulated by a pharmacy licensed by the board of registration in pharmacy shall have affixed to their container by the compounding pharmacy a label notifying prescribed users and practitioners that the drug is either a sterile or non-sterile compounded drug preparation. All pharmacies engaged in sterile or complex non-sterile compounding and licensed under sections 39G to 39I, inclusive, of chapter 112 shall provide a telephone number to foster communication between patients in the commonwealth and a pharmacist employed by the pharmacy who has access to the patient's records. The phone shall be staffed during regular hours of operation every day and not less than 56 hours per week. The phone number shall be affixed to the drug's container, alongside the label notifying prescribed users and practitioners of the fact that the drug is a compounded drug preparation. This paragraph shall not apply to an institutional pharmacy licensed pursuant to section 39I of chapter 112 if the sterile drug preparation compounded by such pharmacy is to be administered to an individual admitted as an inpatient within the same hospital.

Section 21. The pharmacist filling a written, electronic or oral prescription for a controlled substance shall package the controlled substance in a container, affixing to the container a label showing the date of filling, the pharmacy name and address, the filling pharmacist's initials, the serial number of the prescription, the name of the patient, unless it is a veterinary prescription, the name of the prescribing practitioner, the name of the controlled substance, directions for use and cautionary statements, if any, contained in such prescription or required by law, and if the controlled substance is dispensed as tablets or capsules the number of same in such container.

Upon the request of an elderly person, as defined in section fourteen of chapter nineteen A or a person visually impaired, directions on the label affixed by the pharmacist to a container of a prescription drug shall be typed in a print size allowing no more than ten characters per inch.

The department, in consultation with relevant stakeholders and experts in the treatment and management of acute and chronic pain, and based in part on the Pain Management Best Practices Inter–Agency Task Force Report issued by the United States Department of Health and Human Services, shall produce and distribute, either in written or electronic form, to pharmacies, not including institutional pharmacies, pamphlets for consumers relative to narcotic drugs, including opiates, that shall include educational information related to: (i) pain management and the use and availability of non-opioid alternatives for the treatment of acute and chronic pain, including, but not limited to: (A) information on available non-opioid alternatives for the treatment of pain, including non-opioid medications and non-pharmacological therapies; and (B) the advantages and disadvantages of the use of such non-opioid treatment alternatives; (ii) the consumer's option to fill a prescription for a schedule II controlled substance in a lesser quantity than indicated on the prescription pursuant to subsection (d|b5) of section 18; (iii) misuse and abuse of narcotics by adults and children; (iv) the risk of dependency and addiction associated with narcotics use; (v) proper storage and disposal of narcotics; (vi) addiction support and treatment resources; (vii) the telephone helpline operated by the bureau of substance addiction services established in section 18 of chapter 17; (viii) the risks of unintended overdoses associated with prescription opioid use, including, but not limited to: (A) mixing any opioid with stimulants or respiratory depressants, including, but not limited to, alcohol and benzodiazepines; and (B) changes in personal tolerance levels for persons with a history of overdose; and (ix) risk reduction measures to prevent, respond to and reverse an opioid overdose. A pharmacist shall distribute the pamphlet when dispensing a narcotic or controlled substance contained in schedule II or III; provided, however, that pharmacists shall not be required to distribute the pamphlet if: (1) the patient is receiving outpatient palliative care pursuant to section 227 of chapter 111; (2) the patient is a resident of a long-term care facility; or (3) the narcotic or controlled substance is prescribed for use in the treatment of substance use disorder or opioid dependence. For the purposes of this section, non-opioid treatment alternatives shall include, but shall not be limited to, medications, restorative therapies, interventional procedures, behavioral health approaches and complementary and integrative treatments.

The labeling provisions of this section shall apply to the compounding and dispensing of drugs on the oral, electronic or written prescription of a licensed and registered prescriber under section 9. All drug preparations compounded, made or formulated by a pharmacy licensed by the board of registration in pharmacy shall have affixed to their container by the compounding pharmacy a label notifying prescribed users and practitioners that the drug is either a sterile or non-sterile compounded drug preparation.

All pharmacies engaged in sterile or complex non-sterile compounding and licensed under sections 39G to 39I, inclusive, of chapter 112 shall provide a telephone number to foster communication between patients in the commonwealth and a pharmacist employed by the pharmacy who has access to the patient's records. The phone shall be staffed during regular hours of operation every day and not less than 56 hours per week. The phone number shall be affixed to the drug's container, alongside the label notifying prescribed users and practitioners of the fact that the drug is a compounded drug preparation. This paragraph shall not apply to an institutional pharmacy licensed pursuant to section 39I of chapter 112 if the sterile drug preparation compounded by such pharmacy is to be administered to an individual admitted as an inpatient within the same hospital.