BILL ANALYSIS
S.B. 1100
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By: Van de Putte
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Public Health
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Committee Report
(Unamended)
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BACKGROUND AND PURPOSE
Pharmaceutical compounding
refers to the creation of a pharmaceutical product by mixing chemical
ingredients. Interested parties assert that this process is often done to
tailor medications to the needs of specific clients, such as changing the
form of a medication from a solid pill to an ingestible or injectable liquid,
to avoid a nonessential ingredient to which the patient has an allergy or to
obtain an exact dosage of particular active pharmaceutical ingredients.
After a recent outbreak of
fungal meningitis caused by tainted injections prepared by a compounding
center in Massachusetts that exposed thousands of people in many different states
to contaminated drugs, concerned parties observe that out-of-state
compounding pharmacies can currently sell and ship their products to patients
and health care providers in Texas without having to adhere to the same
requirements as in-state compounders. S.B. 1100 seeks to prevent a
potentially deadly outbreak in Texas by amending current law relating to the
licensing and inspection of certain out-of-state pharmacies by the Texas
State Board of Pharmacy.
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RULEMAKING AUTHORITY
It is the committee's opinion
that rulemaking authority is expressly granted to the Texas State Board of
Pharmacy in SECTION 11 of this bill.
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ANALYSIS
S.B. 1100 amends the
Occupations Code to prohibit a pharmacy from compounding and dispensing a
sterile preparation unless the pharmacy holds a license as required by Texas
State Board of Pharmacy rule. The bill requires a pharmacy that compounds a
sterile preparation to notify the board immediately of any adverse effects
reported to the pharmacy or that are known by the pharmacy to be potentially
attributable to a sterile preparation compounded by the pharmacy and to
notify the board not later than 24 hours after the pharmacy issues a recall
for a sterile preparation compounded by the pharmacy.
S.B. 1100 authorizes the board to
inspect a nonresident pharmacy licensed by the board that compounds sterile
preparations as necessary to ensure compliance with safety standards and
other requirements of the Texas Pharmacy Act and board rules. The bill
requires a nonresident pharmacy to reimburse the board for all expenses,
including travel, incurred by the board in inspecting the pharmacy. The bill prohibits
a pharmacy located in another state from shipping, mailing, or delivering to
Texas a prescription drug or device dispensed or delivered as authorized by
statutory provisions relating to compounded and prepackaged drugs unless the
pharmacy is licensed by the board or is exempt from licensing requirements
because the state in which the pharmacy is located restricts the pharmacy's
dispensing of a prescription drug or device to a Texas resident.
S.B. 1100 makes a requirement
that the application of an applicant for a pharmacy license include the license
number of each pharmacist who is licensed to practice pharmacy in Texas
applicable to a pharmacy that is located in another state, rather than a
Class E pharmacy. The bill requires a pharmacy located in another state that
applies for a license, rather than an applicant for a Class E pharmacy
license, to provide certain additional information to the board. The bill
includes among the additional required information evidence of the
applicant's ability to provide to the board a record of a prescription drug
order delivered as authorized by statutory provisions relating to compounded
and prepackaged drugs by the applicant and any other information the board
determines necessary. The bill includes a practitioner in Texas, in addition
to a Texas resident, among the recipients of such a drug order to which
evidence of the applicant's ability to provide record of the order applies. The
bill prohibits the issuance of a license to a pharmacy that compounds sterile
preparations unless the pharmacy has been inspected by the board to ensure
the pharmacy meets the safety standards and other requirements of the Texas
Pharmacy Act and board rules. The bill authorizes the board to accept, as
satisfying the inspection requirement for issuing a license to a pharmacy
located in another state, an inspection report issued by the pharmacy
licensing board in the state in which the pharmacy is located if the board
determines that the other state has comparable standards and regulations
applicable to pharmacies, including standards and regulations related to
health and safety, and if the pharmacy provides to the board any requested
documentation related to the inspection.
S.B. 1100 prohibits a pharmacy
that compounds sterile preparations from renewing a pharmacy license unless
the pharmacy has been inspected as provided by board rule and, if the
pharmacy is located in another state, has reimbursed the board for all
expenses, including travel, incurred by the board in inspecting the pharmacy
during the term of the expiring license. The bill authorizes the board to accept,
as satisfying the inspection requirement for renewing a license of a pharmacy
located in another state, an inspection report issued by the pharmacy
licensing board in the state in which the pharmacy is located if the board
determines that the other state has comparable standards and regulations
applicable to pharmacies, including standards and regulations related to
health and safety, and if the pharmacy provides to the board any requested
documentation related to the inspection.
S.B. 1100 makes a requirement
that a pharmacy report to the board a final order against the pharmacy
license holder by the regulatory or licensing agency of the state in which
the pharmacy is located and a final order against a pharmacist who is
designated as the pharmacist-in-charge of the pharmacy by such a regulatory
or licensing agency applicable to a pharmacy located in another state, rather
than a Class E pharmacy.
S.B. 1100 replaces references
to a Class E pharmacy license holder with references to a nonresident pharmacy
in certain statutory provisions relating to disciplining such a license
holder. The bill requires the board to adopt rules necessary to implement the
bill's provisions not later than March 1, 2014.
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EFFECTIVE DATE
September 1, 2013.
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