H2084B2665A03752 NES:JMT 03/25/24 #90 A03752
AMENDMENTS TO HOUSE BILL NO. 2084
Sponsor: REPRESENTATIVE FRANKEL
Printer's No. 2665
Amend Bill, page 1, line 6, by striking out the period after
"definitions" and inserting
, for license application and for storage, handling and
recordkeeping.
Amend Bill, page 1, lines 19 and 20; page 2, lines 1 through
3; by striking out all of said lines on said pages and inserting
"Virtual manufacturer." A person with a place of business
located in this Commonwealth in the business of manufacturing
and distributing a drug or medical device that:
(1) Holds the drug or device approval and label code or
is otherwise identified on the product label from the United
States Food and Drug Administration.
(2) At no time takes physical possession of any drug or
device in this Commonwealth.
Amend Bill, page 2, line 14, by striking out all of said line
and inserting
Section 2. Section 5(a) of the act is amended by adding
paragraphs and the section is amended by adding a subsection to
read:
Section 5. License application.
(a) Information on application.--An applicant for a license
shall provide the following information on a license application
form approved by the department:
* * *
(1.1) Documentation showing compliance with all Federal,
State and local business registration requirements.
* * *
(6.1) A surety bond in accordance with subsection (a.1).
* * *
(a.1) Bond requirement.--The applicant or owner shall submit
a surety bond of $100,000 to the department with an application.
The department may reduce the amount of the surety bond if the
annual gross receipts is expected to be under $10,000,000 at the
facility location. The surety bond may not be reduced to less
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than $25,000.
* * *
Section 3. Section 6(a) of the act is amended and the
section is amended by adding a subsection to read:
Section 6. Storage, handling and recordkeeping.
(a) Minimum requirements.--[Licensees] Except as provided
under subsection (a.1), licensees and [their] the licensees'
officers, agents, representatives and employees shall satisfy
the minimum requirements of this section for the storage and
handling of prescription drugs and for the establishment and
maintenance of prescription drug distribution records.
(a.1) Virtual manufacturers.--The following requirements
apply to virtual manufacturers:
(1) A virtual manufacturer shall be exempt from the
minimum requirements under subsections (b), (c), (d), (e),
(f) and (j) at the virtual manufacturer's principal place of
business listed on an application that was submitted to the
department under section 5(a)(1) where no drug or devices are
physically stored or handled.
(2) A virtual manufacturer shall ensure that the minimum
requirements under subsections (b), (c), (d), (e), (f) and
(j) are met at any locations or contract facilities where any
drug or medical devices are physically stored or handled on
the virtual manufacturer's behalf.
* * *
Section 4. This act shall take effect in 180 days.
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