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July 14, 2014

Important Compounding Pharmacy Law Empowers Board of Registration in Pharmacy

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On July 10, 2014, Massachusetts Governor Deval Patrick signed into law House Bill Number 4235 - An Act relative to pharmacy practice in the Commonwealth, now codified as Chapter 159 of the Acts of 2014. The law reorganizes the Board of Registration in Pharmacy (“Board”). The overall effect is to promote transparency within the Board membership, empower it to issue specialty licenses, as well as provide it with the authority to more effectively impose fines for violations. The changes also seek to regulate out-of-state compounding pharmacies by requiring licensure for all out-of-state pharmacies that deliver and dispense medications in the Commonwealth. The law provides a new definition of “Serious Adverse Drug Event”, and expands on how such events are to be reported. In addition, the Board will be required to participate in national reporting systems that relate to pharmacies, pharmacists and pharmacy technicians.

Provided below is a brief summary of select key parts of the law:

Board Reorganization

The governor will appoint thirteen Board members who are residents of the Commonwealth, each serving a three-year term. The Board will be comprised of the following: eight registered pharmacists; one pharmacy technician; one representative of the public with experience in healthcare service delivery, administration or consumer advocacy, subject to section 9B; one physician registered pursuant to chapter 112; one nurse registered pursuant to said chapter 112; and one expert in patient safety and quality improvement.

The eight registered pharmacists shall each have at least seven 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 to the Board. At the time of appointment or reappointment, at least two of the eight registered pharmacist members shall be independent pharmacists employed in an independent pharmacy setting. Pharmacist members must be from the following settings: at least two chain, one hospital, one long-term care, one with experience in sterile compounding and one from academia.

Inspection/Violation

Inspectors are required to conduct planned and unplanned inspections of all licensed compounding pharmacies in the state, and out-of-state pharmacies must participate in the state’s Prescription Monitoring Program. The Board inspectors must be trained in sterile and non-sterile compounding practices, and will be verifying compliance with the new statutory requirements as well as regulations to be promulgated by the Board. The new law permits the Board to assess a licensed pharmacy a penalty of not more than $25,000 for each violation and up to $1,000 for each day that a violation continues after the date it should have been corrected.

New Definition of “Serious Adverse Drug Event” and expansion of reporting requirements

The law creates a new definition of, and new reporting methods for, a “serious adverse drug event.” A serious adverse drug event is defined as:

any untoward, preventable medical occurrence associated with the use of a drug in humans 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; (v) a congenital anomaly or birth defect; or (vi) any other kind of harm as determined by the department.

Reporting of such an event has been expanded to include, in addition to other reporting requirements, reporting to both the federal Food and Drug Administration’s MedWatch Program as well as to the pharmacy from which the drug was produced, compounded or dispensed.

Pharmacists' Continuing Education Requirements Expanded

The Board will require registered pharmacists seeking personal registration renewal to complete continuing education requirements. Each pharmacist will need to have a minimum of twenty contact hours each calendar year of the two-year renewal cycle. Pharmacists practicing in sterile and complex non-sterile compounding pharmacies must devote a certain number of those contact hours to their specific area of sterile or complex non-sterile compounding.

Specialty Licenses

The Board may establish “specialty pharmacy licenses” such as, but not limited to: retail sterile compounding specialty license; a retail complex non-sterile compounding specialty license; an institutional pharmacy specialty license (sterile compounding), which applies but is not limited to hospitals; and an out-of-state pharmacy license for out-of-state pharmacies doing business in Massachusetts.

Patient Assistance

All retail and institutional pharmacies will be required to maintain a patients assistance hotline.

About the Author

Andrew Levine

Andrew Levine is a partner and head of the firm's regulatory practice. He provides regulatory guidance, business and corporate legal services, as well as strategic advice to healthcare clients. You can find him on Google+ and LinkedIn.

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