Amendment ID: S21-3

Amendment 3

Outsourcing Facilities License

Mr. Rush moves to amend the amendment by inserting at the end thereof the following new section:-

"SECTION XX.  (a) Chapter 29 of the General Laws, as appearing in the 2012 Official Edition, is hereby amended by inserting the following new section:-

Section 2LLLL.  There shall be established and set upon the books of the commonwealth a separate fund to be known as the Outsourcing Facility Trust Fund, to be expended without prior appropriation by the department of public health.  The fund shall consist of revenue generated from fees collected as authorized by chapter 159 of the acts of 2014. The commissioner of public health or a designee shall administer the fund and shall make expenditures from the fund for the cost of inspections of outsourcing facilities.  The commissioner shall promulgate rules and regulations for the administration and implementation of this section.

(b) Section 18 of Chapter 159 of the Acts of 2014, is hereby amended by inserting after the definition of “non-resident pharmacy” in section 39D the following definition:-

'Outsourcing facility', a facility engaged in the compounding of sterile drugs and is registered pursuant to 21 U.S.C. §353b.  Outsourcing facilities operating in the commonwealth must hold an outsourcing facility pharmacy license.

(c)  Chapter 159 of the Acts of 2014 is hereby amended by inserting the following new section:-

The department of public health shall promulgate rules and regulations establishing a pharmacy licensure category for outsourcing facilities operating pursuant to 21 U.S.C. §353b within 90 days of the passage of this Act.  The department’s regulations shall include, but not be limited to reporting requirements, including product list and shipping volumes, names of customers located in the commonwealth, adverse events reported to the Federal Drug Administration and any enforcement actions from the Federal Drug Administration or the federal Drug Enforcement Administration.  The department shall require licensed outsourcing facilities to be in compliance with all federal requirements pursuant to 21 U.S.C. §353b, including compliance with Current Good Manufacturing Practice regulations under 21 CFR 211 and all Federal Drug Administration 'guidance documents' and 'points to consider' documents. The department shall collect fees necessary to administer the full cost of such regulations."