Section 39D: Definitions applicable to Secs. 39D to 42D; reporting of improper dispensing of prescription drugs; reporting of serious adverse drug events; recall and reporting of defective drug preparation
[ Introductory paragraph of subsection (a) effective until July 1, 2015. For text effective July 1, 2015, see below.]
Section 39D. (a) As used in this section and in sections 39F to 42D, inclusive, the following words shall, unless the context clearly requires otherwise, have the following meanings:--
[ Introductory paragraph of subsection (a) as amended by 2015, 46, Sec. 97 effective July 1, 2015. See 2015, 46, Sec. 216. For text effective until July 1, 2015, see above.]
(a) As used in this section and in sections 36E to 42D, inclusive, the following words shall, unless the context clearly requires otherwise, have the following meanings:--
"Accountability documentation'', physical documentation validating the lot numbers and expiration dates or beyond-use dates of drugs or drug preparations with a patient drug prescription order from a practitioner listed in section 9 of chapter 94C; provided, that "accountability documentation'' shall include evidence of receipt of patient-specific prescriptions prior to dispensing in accordance with section 17 of said chapter 94C. The purpose of accountability documentation shall be: to facilitate tracing of a complex non-sterile drug preparation or sterile drug preparation back to the pharmacy where it was compounded; identify the individual, pharmacy technician or automated compounding device that compounded the complex non-sterile drug preparation or sterile drug preparation; and identify the prescription order that generated the compounding of the complex non-sterile drug preparation or sterile drug preparation.
"Beyond-use date'', the date or time beyond which a drug preparation is not recommended to be dispensed, administered, stored or transported; provided, that the "beyond-use date'' shall be determined from the date or time the drug preparation is compounded.
"cGMP'', Current Good Manufacturing Practice regulations enforced by the federal Food and Drug Administration.
"Complex non-sterile compounding'', engaging in the compounding of a complex non-sterile drug preparation.
"Complex non-sterile drug preparation'', a compounded drug preparation which requires special training, a special environment or special facilities or equipment or the use of compounding techniques and procedures that may present an elevated risk to the compounder or the patient, as defined by the board through regulation; provided, that the regulations promulgated by the board, which are applicable to this definition, shall be consistent with the category of complex non-sterile compounding described in chapter 795 of the USP.
"Compounding'', the preparation, mixing, assembling, packaging or labeling of 1 or more active ingredients with 1 or more other substances by or under the supervision of a licensed pharmacist within a licensed pharmacy to create a final drug preparation that is formulated:
(1) for use on or for a patient as a result of a practitioner's prescription order, based on the relationship between the practitioner, patient and pharmacist in the course of routine professional practice to meet the unique medical need of an individual patient by producing a significant difference between the compounded drug preparation and a comparable commercially available drug that is justified by a documented medical need as determined by the prescribing practitioner including, but not limited to, the removal of a dye for medical reasons, a change in strength, a change in dosage, form or delivery mechanism; provided, that a price difference shall not be a significant difference to justify compounding;
(2) in anticipation of prescription orders based on routine, regularly-observed prescribing patterns which can be verified by accountability documentation; or
(3) for the purpose of, or as an incident to, research, teaching or chemical analysis and not for sale or dispensing.
Except as provided in clause (1), "compounding'' shall not include the preparation of commercially available, federal Food and Drug Administration approved drugs or drug preparations.
"Institutional pharmacy'', the physical portion or satellite unit of an organization including, but not limited to, hospitals, health maintenance organizations and clinic pharmacies, whose primary purpose is to provide a physical environment for patients to obtain health care services under the supervision of a licensed pharmacist and is authorized to dispense controlled substances.
"Institutional sterile compounding pharmacy'', an institutional pharmacy that prepares a sterile drug preparation.
"Manager of record'' or "pharmacist in charge'', a licensed pharmacist who signs the application for a pharmacy permit and assumes full legal responsibility for the operation of the relevant pharmacy in a manner complying with the laws and regulations for the practice of pharmacy and the sale and dispensing of controlled substances. The manager of record shall personally supervise the pharmacy and pharmacy personnel as required by section 39.
"Non-resident pharmacy'', any pharmacy located outside of the commonwealth that prescribes, ships, mails, sells or dispenses medications in the commonwealth.
"Pharmacy'', any entity engaged in the drug business, as defined in section 37, or that engages in the practice of compounding to fulfill a practitioner prescription.
"Practitioner'', a person who, under section 9 of chapter 94C, may prescribe or dispense controlled substances.
"Quality assurance'', a set of activities used to ensure that compounding processes lead, with a high degree of assurance and certainty, to finished drug preparations meeting pre-determined specifications and standards of quality.
"Retail complex non-sterile compounding pharmacy'', a retail pharmacy or facility that prepares a complex non-sterile drug preparation.
"Retail sterile compounding pharmacy'', a retail pharmacy or facility that prepares a sterile drug preparation.
"Sterile compounding'', engaging in the compounding of a sterile drug preparation.
"Sterile drug preparation'', a compounded biologic, diagnostic, drug, nutrient or radiopharmaceutical, which under chapter 797 of the USP or the cGMP shall be compounded using aseptic techniques; provided, that "sterile drug preparation'' may include, but shall not limited to, implants, injectables, parenteral nutrition solutions, irrigation solutions, inhalation solution, intravenous solutions and ophthalmic preparations.
"USP '', the current edition of the United States Pharmacopeia and the National Formulary.
(b) A pharmacy shall inform the department of public health of any improper dispensing of a prescription drug that results in serious injury or death, as defined by the department in regulations, as soon as is reasonably and practically possible, but not later than 7 business days after discovery of the improper dispensing.
(c) The manager of record of a pharmacy shall report any serious adverse drug event, as defined in section 51H of chapter 111, occurring as a result of the patient's interaction with any drug or pharmaceutical manufactured, produced or compounded at the manager of record's pharmacy, to the board, the federal Food and Drug Administration MedWatch Program and the Betsy Lehman center for patient safety and medical error reduction. This data shall be reported to the board within 7 business days of the knowledge of any serious adverse drug event by any pharmacy employee.
(d) All data concerning serious adverse drug events reported to the board shall be collected, synthesized and analyzed by the board in a traceable and easily navigable database format using information technology. The board shall use the data to track trends in serious adverse drug events and to warn patients, consumers and pharmacies of any trends which could pose a danger to public health and safety. Data collected pursuant to this subsection shall be made available on the searchable website established pursuant to section 42B.
(e) If a pharmacy knows or should have reason to know that a drug preparation compounded, dispensed or distributed by the pharmacy is or may be defective in any way, the pharmacy shall immediately recall the drug preparation. Any of the same drug preparation remaining in the possession of the pharmacy shall be located and segregated and shall not be distributed or dispensed. A defective drug preparation log documenting the recalled drug preparation shall be kept by the pharmacy including information on:
(1) the drug preparation name, potency and dosage form;
(2) the reason for the recall;
(3) the amount of the drug preparation made;
(4) the date that the drug preparation was made;
(5) the amount of the drug preparation dispensed or distributed;
(6) the actual drug preparation potency and dosage form; and
(7) any and all serious adverse drug events related to the drug preparation in question.
The defective drug preparation log shall be made available to the board within 7 days of the recall and shall be kept on record for at least 10 years. Upon submission of the defective drug preparation log to the board, the pharmacy shall work with the board to develop a corrective action plan that rectifies the error that resulted in the defective drug preparation.
(f) The department of public health shall promulgate regulations for the administration and enforcement of this section.