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HOUSE DOCKET, NO.                 FILED ON: 7/9/2013

HOUSE  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  No. 3548

 

 

The Commonwealth of Massachusetts

 

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In the Year Two Thousand Thirteen

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An Act relative to Pharmacy Practice in the Commonwealth.

 

              Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority of the same, as follows:
 

              SECTION 1. Chapter 13 of the General Laws is hereby amended by striking out section 22 and inserting in place thereof the following sections: -

              Section 22. (a) There shall be a board of registration in pharmacy, called the “board” in this section and sections 23 to 25A inclusive. The governor shall appoint 11 members to the board. Members shall be residents of the commonwealth. The composition of the board shall be as follows: 6 registered pharmacists; 1 pharmacy technician; 1 representatives of the public with experience in health care service delivery, administration, or consumer advocacy, subject to the provisions of section 9B; 1 physician registered under chapter 112; 1 nurse registered under chapter 112; and 1 expert in patient safety and quality improvement.

              (b) The 6 registered pharmacists shall each have had at least 7 consecutive years of experience in the practice of pharmacy and shall be currently employed in the practice of pharmacy in the commonwealth at the time of appointment or reappointment.

              (c) At the time of appointment or reappointment to the board, at least 1 of the 6 registered pharmacist members shall be an independent pharmacist employed in the independent pharmacy setting. For the purposes of this section “independent pharmacist” shall mean a pharmacist actively engaged in the business of retail pharmacy and employed in an organization of 9 or fewer registered retail drugstores in the commonwealth under section 39 of chapter 112 and employing not more than 20 full-time pharmacists.

              (d) At the time of appointment or reappointment to the board, at least 1 of the 6 registered pharmacist members shall be a chain pharmacist employed in the chain pharmacy setting. For the purposes of this section “chain pharmacist” shall mean a pharmacist in the employ of a retail drug organization operating 10 or more retail drug stores within the commonwealth under section 39 of chapter 112.

              (e) At the time of appointment or reappointment to the board, at least 1 of the 6 registered pharmacist members shall have had at least 7 years of experience in a hospital setting in the commonwealth.

              (f) At the time of appointment or reappointment to the board, at least 1 of the 6 registered pharmacist members shall have had at least 7 years of experience employed in a long-term care pharmacy setting.

              (g) At the time of appointment or reappointment to the board, at least 1 of the 6 registered pharmacist members shall have had at least 7 years of experience in the practice of compounding sterile drug preparations, as defined in section 39D of chapter 112, and shall be engaged in compounding sterile drug preparations as a routine function of their employment.

              (h) At the time of appointment or reappointment to the board, at least 1 of the 6 registered pharmacist members shall be employed in an academic or scholarly position with an institution of higher learning licensed under the laws of the commonwealth.

              (i) Not more than 1 pharmacist in any 1 practice setting defined in subsections (c) to (g), inclusive, may serve on the board at any one time.

              (j) At the time of appointment or reappointment to the board, the pharmacy technician member shall have had at least 7 years of practical experience as a pharmacy technician and shall actually be engaged in the practice of pharmacy as a routine function of their employment.

              (k) At the time of appointment or reappointment to the board, no registered pharmacist or pharmacy technician shall have had any type of disciplinary or enforcement action taken against them by the board or the federal Food and Drug Administration or the federal Drug Enforcement Administration during the 10 years preceding their appointment to the board.

              (l) For the purposes of this section, “public member” shall mean a person whose background and experience qualify them to act on the board in the public interest, including experience in health care service delivery, administration, or consumer advocacy, and who meets the provisions of paragraph (4) of subsection (a) of section 9B.

              (m) Board members shall be appointed and shall serve for a term of 3 years from the first of the month following appointment. No member may serve more than 2 consecutive terms on the board. Members who have served the maximum number of consecutive terms shall be eligible for reappointment after not serving for at least one term.

              (n) Board members may be removed by the governor, only for reasonable cause of neglect of duty, misconduct, malfeasance, or misfeasance in office. Prior to removal, such member shall be given written notice of the basis for removal and be afforded a hearing before the governor or designee. Such member may appear at the hearing with witnesses and be represented by counsel. The hearing shall be held within 21 days of the notice.

              SECTION 2. Section 23 of chapter 13, as so appearing, is hereby amended by adding the following paragraph:-

              A member may serve up to 1 year as secretary and up to 1 year as president during any single term

              SECTION 3.  Section 25 of chapter 13, as so appearing, is hereby amended by striking out, in line 1, the words “no more than six”.

              SECTION 4.  Chapter 13, as so appearing, is hereby further amended by inserting after section 25 the following section:-

              Section 25A. As directed by the board, all inspecting agents shall be trained in USP 797 and USP 795 as well as additional sterile compounding surveyor courses. This training shall include, but not be limited to, programs offered free of charge by the National Association of Boards of Pharmacy.

              SECTION 5. Section 21 of chapter 94C, as appearing in the 2012 Official Edition, is hereby amended by adding the following 3 paragraphs:

              The labeling provisions of this section shall apply to the compounding and dispensing of drugs on the oral or written prescription of a licensed and registered prescriber as defined under section 9.

              All compounded 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 of the fact that the drug is either a sterile or non-sterile compounded drug preparation.

              All sterile compounding pharmacies, as defined in section 39D of chapter 112, shall, during regular hours of operation and not less than 7 days a week, at a minimum of 56 hours per week, provide a telephone number to foster communication between patients in the commonwealth and a pharmacist employed by the pharmacy with access to the patient’s records. The phone number shall also be affixed to the container, alongside the label notifying prescribed users and practitioners of the fact that the drug is a compounded drug preparation.

              SECTION 6. Section 51H of Chapter 111, as so appearing, is hereby amended by inserting after the definition “Healthcare-associated infection”, the following definition:-

              “Practitioner”, a licensed and registered prescriber, as defined under section 9 of chapter 94C.

              SECTION 7. Section 51H of chapter 111, as so appearing, is hereby amended by striking out the definition “serious adverse drug event” and inserting in place thereof the following definition:-

              “Serious adverse drug event”, any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that results in any of the following outcomes: (i) death; (ii) a life-threatening outcome; (iii) inpatient hospitalization or prolongation of existing hospitalization; (iv) a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; or (v) a congenital anomaly or birth defect. Important medical occurrences associated with the use of a drug in humans that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

              SECTION 8. Subsection (b) of section 51H of chapter 111, as so appearing, is hereby amended by adding the following sentence:- The practitioner or other licensed healthcare provider, who discovers a serious adverse drug event resulting from a patient’s use, consumption or interaction with any pharmaceutical or drug preparation, shall report the event to the federal Food and Drug Administration’s MedWatch Program, as well as the pharmacy from which the drug was produced, compounded or dispensed in addition to all other reporting requirements.

              SECTION 9. Section 51H of chapter 111, as so appearing, is hereby further amended by inserting after the word “reduction”, in line 29, the following words:- “,the bureau of healthcare safety and quality within the department and the board of registration in pharmacy.

              SECTION 10. Section 2 of chapter 111N, as so appearing, is hereby amended by striking out the first paragraph and inserting in place thereof the following paragraph:-

              Notwithstanding any general or special law to the contrary, the department shall adopt a standard marketing code of conduct for all pharmaceutical or medical device compounding or manufacturing companies that employ a person to sell or market prescription drugs or medical devices in the commonwealth. The marketing code of conduct shall be based on applicable legal standards and incorporate principles of health care including, without limitation; requirements that the activities of the pharmaceutical or medical device compounder or manufacturer agents be intended to benefit patients, enhance the practice of medicine and not interfere with the independent judgment of health care practitioners. In promulgating regulations for a marketing code of conduct, the department adopt regulations that shall be no less restrictive than the most recent version of the Code on Interactions with Healthcare Professionals developed by the Pharmaceutical Research and Manufacturers of America and the Code on Interactions with Healthcare Professionals developed by the Advanced Medical Technology Association.

              SECTION 11. Section 24 of chapter 112 of the General Laws, as appearing in the 2012 Official Edition is hereby amended by striking out the word “forty-two”, in line 5, and inserting in place thereof the following word:- 42A.

              SECTION 12. Section 24A of chapter 112 as so appearing, is hereby amended by striking out the second paragraph and inserting in place thereof the following 3 paragraphs:-

              The board shall require each registered pharmacist seeking personal registration renewal to complete continuing education requirements as a condition precedent to such renewal. No registrant shall be eligible for renewal of a personal registration without completion of the requisite number of contact hours for such renewal. A registrant seeking renewal of a personal registration must complete a minimum of 20 contact hours each calendar year of the 2-year renewal cycle. Of the 20 contact hours effective for the renewal period beginning January 1, 2014 any pharmacist licensed by the commonwealth shall devote at least 5 of the 20 contact hours in the area of sterile compounding

              The board, in consultation with an advisory committee of industry experts as established by section 42¾ of chapter 112, shall adopt further rules and regulations for a system of continuing education, in addition to the aforementioned requirements listed in this section. The board shall accept all conferences and programs from providers approved by the American Council on Pharmaceutical Education meeting these requirements.

              The board shall also conduct an audit of randomly selected, renewed licenses. Individuals selected for an audit will be mailed a request from the board of pharmacy to provide documented proof of completion of contact hour requirements. The name and date of licensees included in this audit shall be posted on the board website. Pharmacists in violation of this requirement will be fined no more than $1000.

              SECTION 13. Said chapter 112, as so appearing, is hereby further amended by inserting after section 25 the following section:-

              Section 25A (a) The board shall submit an annual report to the joint committee on public health and joint committee on health care finance on or before December 31 detailing the investigatory and disciplinary actions conducted by the board; provided further, that the initial report shall detail (1) each complaint received by the board or initiated by the board; (2) the date of the complaint; (3) the violation alleged; (4) the name of any state or federal agencies that collaborated with the investigation (5) the summary of and rationale for the final decision of the board to; (i) dismiss the complaint, (ii) impose an informal sanction or penalty, (iii) impose a formal sanction or penalty or (iv) amend a previously issued sanction or penalty; and (6) whether or not the board reported the result of its investigation to another state board, federal agency or external entity.

              (b) All relevant data collected, synthesized and analyzed under subsections (b) through (e), inclusive, of section 39D shall also be summarized and included in this report which the board shall compile and submit annually to the joint committee on public health, the joint committee on health care finance and the commissioner of the department of public health on or before December 31 and shall make the compilation widely available, including by electronic means, to the public, all hospitals, pharmacies and health care providers doing business in the commonwealth.

              SECTION 14. Section 32 of chapter 112 of the General Laws, as so appearing, is hereby amended by the following paragraph:-

              The board shall participate in any national data reporting system which provides information on individual pharmacies, pharmacists and pharmacy technicians including, but not limited to, relevant databases maintained by the National Association of the Boards of Pharmacy and the federal Food and Drug Administration.

              SECTION 15. The second paragraph of section 39 of said chapter 112, as so appearing, is hereby amended by striking out the second sentence.

              SECTION 16. Said section 39 of said chapter 112, as so appearing, is hereby amended by adding the following paragraph:-

              The board of registration in pharmacy may establish specialty pharmacy licensure categories beyond those delineated in this section, and in sections 39A to C, inclusive, and in sections 39E and 39F, through promulgation of regulation as deemed necessary by the board in consultation with the commissioner of public health. The board shall determine which regulations, applicable to a retail drug business registered under section 39 shall apply to a pharmacy registered under this section and may establish regulations which shall apply only to a licensure category established under this provision. The licensure fee shall be determined annually by the commissioner of the administration under section 3B of chapter 7.

              SECTION 17. Chapter 112 of the General Laws, as so appearing, is hereby amended by striking out section 39D and inserting in place thereof the following 4 sections:-

              Section 39D. (a) As used in this section and in sections 39D½ to 42A, 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 of drugs or products with a patient drug prescription order from a physician licensed to practice medicine in the commonwealth. The purpose of accountability documentation shall be to facilitate tracing of a drug preparation or compounded sterile drug preparation back to the sterile compounding pharmacy it was produced at, an individual who produced the drug, and the prescription order that generated the production or compounding of the drug preparation.

              “Compounding”, the preparation, mixing, assembling, packaging, or labeling of 1 or more active ingredients with 1 or more other substances, towards a final drug preparation, by a pharmacist within a permitted pharmacy only:

              (1) formulated for use on or for the patient as a result of a practitioner’s prescription drug order or initiative, 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 of the practitioner;

              (2) for the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing;

              (3) in anticipation of prescription orders based on routine, regularly-observed prescribing patterns that can be verified by accountability documentation; or

              (4) if compounding does not include the preparation of commercially available, FDA-approved drug preparations. Compounded preparations that produce, for the patient, a significant difference between the compounded drug and the comparable commercially available drug preparation as determined, by the prescriber, as necessary for the medical best interest of the patient are not copies of commercially available preparations. Significant differences may include, but are not limited to, the removal of a dye for medical reasons, changes in strength, and changes in dosage form or delivery mechanism. Price differences are not a significant difference to justify compounding.

              “Compounded sterile drug preparation”, a biologic, diagnostic, drug, nutrient, or radiopharmaceutical that under USP 797 or the federal Food and Drug Administration’s current good manufacturing practices, must be compounded using aseptic techniques. Such preparations may include, but are not limited to, implants, injectables, parenteral nutrition solutions, irrigation solutions, inhalation solution, intravenous solutions and ophthalmic preparations.

              “cGMP” Current Good Manufacturing Practice regulations enforced by the federal Food and Drug Administration.

              “Manager of record”, a person, who, being licensed as a pharmacist, 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.

              “Quality assurance”, a set of activities used to ensure that processes used in preparation of non-sterile or sterile compounded drug preparations lead, with a high degree of assurance and certainty, to finished drug preparations meeting pre-determined specifications and standards of quality.

              “Sterile compounding”, engaging in the compounding of a sterile drug preparations.

              “Sterile compounding pharmacy”, any pharmacy or facility, where a compounded sterile drug preparations is compounded or manufactured

              “USP/NF”, the current edition of the United States Pharmacopeia/National Formulary.

              (b) Stores or pharmacies engaged in the drug business, as defined in section 37, shall inform the department of public health of any improper dispensing of prescription drugs 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 working days after discovery of the improper dispensing.

              (c) The manager of record of a store or pharmacies shall report any serious adverse drug event, as defined in section 51H of chapter 111, occurring as result of patient interaction with any drug or pharmaceutical preparation manufactured, produced or compounded at their pharmacy, to the board, the FDA MedWatch Program and the Betsy Lehman Center for medical error reduction. This data shall be reported to the board within 7 days of the knowledge of any serious adverse drug event by any pharmacy employee.

              (d) All data concerning serious adverse drug events that has been reported to the board of pharmacy, must be collected, synthesized and analyzed in a traceable and easily navigable database format using information technology. Data shall be used to track trends in serious adverse drug events, and warn patients, consumers and pharmacies of any trends which could pose a danger to public health and safety.

              (e) If a sterile compounding pharmacy believes that their compounded sterile drug preparation is defective in any way, the pharmacy shall recall any preparation dispensed or distributed. Any preparation remaining in the outlet shall be isolated, and shall not be distributed or dispensed to anybody. An accurate log of the recalled preparation shall be kept by the pharmacy including information on:

              (1) intended preparation name, potency, dosage form;

              (2) the reason for the recall;

              (3) the amount of preparation made;

              (4) the date that the preparation was made;

              (5) the amount of preparation dispensed or distributed;

              (6) the actual preparation potency and dosage form; and

              (7) any and all serious adverse drug events related to the drug in question. The defective preparation log shall be made available to board of pharmacy inspectors within 7 days of the recall, and shall be kept on record for at least 2 years. Upon submission of the defective preparation log to a board of pharmacy inspector, the pharmacy shall work with the board of pharmacy to develop a corrective action plan that rectifies the error which resulted in a defective preparation.

              (f) The department of public health shall promulgate regulations for the administration and enforcement of this section

              Section 39D 1/2. (a) A pharmacy shall not engage in sterile compounding, nor shall a pharmacy prescribe, ship, mail, sell, transfer or dispense sterile compounded drug preparations in the commonwealth unless the pharmacy has obtained a sterile compounded drug preparations specialty license from the board of registration in pharmacy under this section.

              (b) The sterile compound drug preparations specialty license issued by the board shall be obtained in addition to and shall not replace any other permit or license a sterile compounding pharmacy holds. This license is non-transferable and shall be renewed annually. The fee for such renewal, shall be determined annually by the commissioner of the administration under section 3B of chapter 7

              (c) A pharmacy licensed by the commonwealth intending to compound sterile drug preparations as well as distribute sterile compounded drug preparations to pharmacies, wholesalers or prescribers into or out of state, according to the definition established by this chapter, shall adhere to the most current standards established by USP 797 when engaging in any form of sterile compounding, and shall obtain and hold a sterile compounded drug preparations specialty license appropriate to the definition of this practice. Such pharmacies shall also adhere to the additional regulations promulgated by the board of pharmacy, in consultation with an advisory committee of industry experts as established by section 42¾ of chapter 112,, under subsection (h) of section 39F.

              (d) A pharmacy licensed by the commonwealth, intending to compound sterile drug preparations, and with the additional intent to distribute sterile compounded drug preparations to pharmacies, wholesalers or prescribers into or out of the state in anticipation of a prescription, in volumes inconsistent with routinely observed volume patterns associated with patient-specific prescriptions, or in the absence of accountability documentation, shall adhere to the most current standards established by FDA cGMP when engaging in any form of sterile compounding. Furthermore such pharmacies must obtain and hold a manufactures license appropriate to this definition of practice, from the federal Food and Drug Administration, before engaging in any sterile compounding. The manufacturers license is non-transferable and shall be renewed annually, at a fee which shall be determined annually by the commissioner of the administration under section 3B of chapter 7.

              Section 39F (a) A specialty license to compound or sell compounded sterile drug preparations in the commonwealth shall not be renewed until the location has been inspected by the board and found to be in compliance with this chapter and regulations adopted by the board. 

              (b) The board shall conduct periodic, unannounced random and risk-based inspections of all sterile compounding pharmacies licensed under this chapter to compound sterile drug preparations, as well as the compounded sterile drug preparations produced by these pharmacies.

              (c) The board shall establish a list of  procedural criteria by which a sterile compounding pharmacy can expect to be evaluated on at the time of inspection. The procedural criteria shall contain a pre-determined list of constant standards and safeguards upon which a sterile compounding pharmacy can be assured to be inspected on, as well as a pre-determined yet alternating list of variable criteria upon which the pharmacy can be inspected on, with no prior assurance as to which subset of these variable criteria will be included in the inspection process.

              (d) The board shall, in consultation with an advisory committee of industry experts as established by section 42¾ of chapter 112, develop a quality assurance procedure for sterile compounding pharmacies to adhere to including, but not limited to procedures to enhance: physical inspection, compounding accuracy checks, sterility testing.

              (e) All sterile compounding pharmacies shall certify that they have undergone a lean manufacturing assessment, before they are eligible to receive a sterile compound drug preparations license.

              (f) All sterile compounding pharmacies shall report to the board, on an annual basis, a list of prescriptions dispensed within and out of the state, as well as the volume of prescriptions dispensed within and out of the state. All sterile compounding pharmacies intending to ship their compounded drug preparations out of the state, shall in addition to the requirements in this section, report to which states they have shipped their compounded preparations.

              (g) Resident sterile compounding pharmacies shall require a manager of record to be responsible for the pharmacy’s compliance with this chapter and shall disclose to the board all of the following:

              (1)The location, name and titles of all principal managers and the name and Massachusetts license number of the de signated manager of record. A report containing this information shall be made on an annual basis and within 1 month after any change of office, corporate office or manager of record.

              (2) The pharmacy shall certify its compliance with reasonable informational requests made by the board, in the course of honoring its charge to protect the public health of the citizens of the commonwealth.

              (3) That the manager of record themselves have fulfilled continuing education requirements for sterile compounding, and have ensured that all pharmacy staff engaging in compounding have received the appropriate training and education required by law and regulations.

              (h) The board shall establish supplementary regulations, beyond those established by the current form of USP 797 for all pharmacies intending to compound sterile drug preparations in the commonwealth . The board shall establish these supplementary regulations in consultation with an advisory committee of industry experts as established by section 42¾ of chapter 112,. The regulations shall include, but will not be limited to: (1) enhancing environmental monitoring procedures, (2) enhancing media fill testing procedures, (3) enhancing non-sterile active pharmaceutical ingredient controls, (4) enhancing procedures testing endotoxin and bioburden levels of compounded drug preparations, (5) enhancing procedures surrounding process validation and reproducibility of compounded drug preparations, (6) enhancing procedures related to end stage testing of compounded drug preparations, (7) enhancing procedures relating to the storage and beyond-use-dating of compounded drug preparations, (8) enhancing the physical inspection process for finished sterile compounded drug preparations, (9) developing effective  formulation records for sterile compounding pharmacies, (10) developing effective compounding records for compounded drug preparations produced at sterile compounding pharmacies, (11) developing effective procedures to maintain preparations quality and control after the compounded sterile drug preparation leaves the pharmacy.

              Section 39G. (a) The board shall establish a procedure to license non-resident or out-of-state pharmacies located outside of the commonwealth that prescribe, ship, mail, sell or dispense medications into the commonwealth, that pertain to the practice of pharmacy. In establishing a procedure to license non-resident or out-of-state pharmacies, the board shall ensure that the licensing procedure is equivalent to licensing procedure established by this legislation, for pharmacies licensed to operate in the commonwealth.

              (b) The non-resident pharmacies shall designate a pharmacist in charge who is licensed as a pharmacist in Massachusetts and is responsible for the pharmacy’s compliance with this chapter and shall disclose to the board all of the following:

              (1) The location, name and titles of all principal managers and the name and Massachusetts license number of the designated pharmacist in charge, if applicable. A report containing this information shall be made on an annual basis and within one month after any change of office, corporate office, or manager of record.

              (2) That it maintains, at all times, a current unrestricted license, permit or registration to conduct the pharmacy in compliance with the laws and regulations of the jurisdiction in which it is licensed to practice. The pharmacy must also certify its compliance with reasonable informational requests made by the board, in the course of honoring its charge to protect the public health of the citizens of the commonwealth.

              (3) That it maintains its records of all drugs dispensed to patients in the commonwealth, and makes these records readily retrievable, upon request of the board. This list shall be updated annually, and sent to the board proactively.

              (c) No pharmacy or pharmacist operating outside of the state shall be authorized to prescribe, ship, mail, sell, transfer or dispense drug preparations in to the commonwealth unless the drug preparations are produced in a pharmacy that has been granted a non-resident license by the board.

              (d) No pharmacy or pharmacist operating outside of the state shall be authorized to prescribe, ship, mail, sell, transfer or dispense sterile compounded drug preparations into the commonwealth unless the sterile compounded drug preparations are produced in a pharmacy that has been granted a sterile compounded drug preparations non-resident license by the board.

              SECTION 18. Sections 41 and 42 of chapter 112 of the General Laws are hereby repealed.

              SECTION 19. Chapter 112 of the General Laws, as appearing in the 2012 Official Edition, is hereby amended by inserting after Section 42 the following 3 sections:-

              Section 42 ½   (a) For the purpose of his section, the following words shall have the following meanings:

              “Enforcement action records”, any documents issued by the department of public health to a pharmacy or pharmacist for an infraction or violation of a state or federal statute or regulation by the pharmacy or pharmacist.  These records shall include, but not be limited to, consent decrees or judgments entered into between the department and a licensed pharmacy or pharmacist as a result of a charge or complaint filed by the department against a pharmacy or pharmacist for a statutory or regulatory violation or infraction or any other type of voluntary resolution of a charge or complaint filed by the department.

              “Searchable website”, a website that allows the public at no cost to search for and obtain enforcement action records and serious adverse drug events records, as defined in section 51H of chapter 111, pertaining to pharmacies licensed by the commonwealth

              (b) The commissioner shall develop and operate a searchable website accessible by the public at no cost that includes:

              (1)  copies of all enforcement action records of any pharmacy or pharmacist licensed by the department whether they are located within or without the commonwealth.

              (2) copies of any records of serious adverse drug events, as defined in section 51H of chapter 111, suffered by a patient or user of medications as a result of their use of medication prepared, made or constituted by a pharmacy or pharmacist licensed by the department whether within or without the commonwealth.

              (3) any other relevant information specified by the commissioner.

              (c) The searchable website shall allow users to search electronically by field in a single search, parse, query or aggregate the data, and download information yielded by a search.  The website shall, among other things, permit users to search by a particular pharmacy or pharmacists or by a specific medication.

              (d) The searchable website shall include and retain information for each fiscal year for not less than 10 fiscal years.

              (e) The commissioner shall update the searchable website as new data becomes available.  All agencies or boards of the department shall provide to the commissioner all data that is required to be included in the searchable website no later than 30 days after the data becomes available to the department.  The commissioner shall provide guidance to agency or board heads to ensure compliance with this section.

              (f)  This section shall not be construed to require the disclosure of information of patients or users of medication that is confidential under state or federal law.

              (g) The commissioner shall not be considered in compliance with this section if the data required for the searchable website is not available in a searchable and aggregate manner or if the public is redirected to other government websites, unless each of those websites complies with the requirement of this section.

              Section 42¾. There is hereby established an advisory committee to the board consisting of the following members to be appointed by the commissioner of the department of public health: an expert in United States Pharmacopeia chapter 795, an expert in United States Pharmacopeia 797, and expert in United States Pharmacopeia 71, an expert in federal current good manufacturing practices for aspetic processing, an expert in pharmacoeconomics, an expert in clinical pharmacology, a microbiologist. The advisory committee shall consist of additional members, as determined by the board of registration in pharmacy, if so deemed necessary to fulfill the duties that this committee is charged with. The advisory committee shall advise the board of pharmacy regarding proposed regulations surrounding quality assurance and the inspection and testing of compounded drug products. The advisory committee shall also advise the board of pharmacy regarding proposed regulations to supplement the current form of USP 797. The advisory committee shall also evaluate current trends in pharmacy in the commonwealth, as well as recommended improvements to pharmacy practice in the commonwealth. Furthermore the advisory committee shall evaluate the volume and revenue of drug preparations generated by each licensed sterile compounding pharmacy in the commonwealth. Members of the advisory committee shall serve without compensation, and shall be free of any liability incurred by their proposed recommendation to the board of pharmacy. The advisory committee shall be provided support services by the department of public health.

              The advisory committee to the board is charged with investigating the causes of drug shortages and their relation to the market for compounded drugs in the state of Massachusetts. The advisory committee shall determine an approach to address potential drug shortages when sufficient clinical need or a threat to public health and safety exist.

              The advisory committee to the board is charged with studying the feasibility of a state administered central fill pharmacy for the purposes of compounding and distributing compounded drug preparations for hospitals in the Commonwealth.

              Section 42 7/8. (a) The board may assess a licensed pharmacy a penalty of not more than $25,000 for each violation of regulations or administrative rules established under any general law that governs the practice of pharmacy.

              (b) The board may assess a pharmacy licensed under chapter 112, ordered to correct a violation of regulations or administrative rules established under any general law that governs the practice of pharmacy, a penalty of not more than $1,000 for each violation for each day the violation continues to exist beyond the date prescribed for correction.

              (c) Upon making an assessment, the board shall give the licensee notice of the matters alleged and the provisions of law relied upon and shall accord such person an opportunity for a hearing upon written request within 15 business days of the assessment. If after a hearing, or waiver thereof, the board determines that cause exists, the board shall make an appropriate assessment. The affected licensee shall pay such assessment except to the extent that, upon judicial review, the reviewing court may reverse the final decision of the board.

              (d) An assessment made under this section shall be collected on the thirtieth day after notification to the affected licensee, or on the fifteenth day after resolution of an administrative appeal, and deposited into the quality in health professions trust fund as established by section 10 of chapter 35x. The attorney general shall recover any assessment due and payable brought in the name of the commonwealth in the superior court. Funds collected under section 42B shall be paid as described in procedures established under chapter 112 section 42C.

              SECTION 20. Section 42A of chapter 112, as so appearing, is hereby amended by inserting after the first paragraph the following paragraph:-

              The board shall participate in any national data reporting system which provides information on individual pharmacies, pharmacists and pharmacy technicians including, but not limited to, relevant databases maintained by the National Association of the Boards of Pharmacy and the United States Food and Drug Administration

              SECTION 21. Said section 42A of said chapter 112, as so appearing, is hereby further amended by adding the following 3 paragraphs:

              The board or board president may, without holding a hearing, suspend, or refuse to renew a registrant’s license if the board or board president finds, through reasonable cause, that the health, safety, or welfare of the public warrants such summary action; provided, however, that the board shall, within 7 days of such summary action, afford the registrant the opportunity of a hearing under chapter 30A. Any suspension imposed by the board or board president shall remain in effect until the conclusion of the proceedings including the judicial review thereof, unless sooner dissolved by a court of competent jurisdiction or withdrawn by the board.

              If, based upon evidence, the board or board president determines that a registrant or licensee or the preparations prepared by a registrant or licensee are an immediate threat to the public health, safety, or welfare, the board or board president may: (1) issue a cease and desist notice or quarantine notice requiring the cessation or restriction of any and all pharmacy operations, and prohibiting the use of medications prepared by or in possession of a pharmacy; or (2) issue a cease and desist notice or quarantine notice placing non-disciplinary restrictions on a board registrant or licensee, to the extent necessary to avert a continued threat, pending final investigation results. The board shall promulgate regulations pertaining to the issuance of cease and desist and quarantine notices.

              Monetary penalties collected under section 42A shall be deposited into the quality in health profession trust administered by the department of public health to support initiatives such as patient safety and quality improvement programs for organizations under the jurisdiction of health professions licensure board, training for board staff, and to offset the costs of board business, including investigation, enforcement activities and investments in health information technology. The board shall promulgate regulations for the administration of this fund, in consultation with all health professions licensure boards, including the establishment of eligibility criteria, program requirements, and assessment and reporting processes.

              SECTION 22. Section 187 of Chapter 149 of the General Laws, as appearing in the 2012 Official Edition, is hereby amended by adding the word “pharmacy” after “community health agency” in the definition of “health care facility”.

              SECTION 23. The board of registration in pharmacy, shall, in consultation with the department of public health and an advisory committee of industry experts as established by section 42¾ of chapter 112,, promulgate regulations no later than 180 days after passage of this law pertaining to the inspections and testing of sterile compounding pharmacies, as well as the inspection and testing of compounded sterile drug preparations produced by relevant pharmacies, as required by section 39F of chapter 112 of the General Laws.

              SECTION 24. Notwithstanding any general or special law to the contrary, the initial report, as required by section 25A of chapter 112 of the General Laws shall detail the investigatory and disciplinary actions conducted by the board of registration in pharmacy from September 1, 2012 through December 1, 2013.

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