Protection of the Citizens of Texas
In order for the Board to continue to protect the citizens of Texas, it must have adequate funds and
staff. The almost 60,000 pharmacy technicians and trainees licensed by the agency have had a
dramatic effect on the agency’s operations. Of particular concern to the agency is the growth in the
number of disciplinary orders entered by the agency and the continuing growth in the number of
complaints received. Since FY2008, the agency has experienced a 5% increase in the number of
complaints; a 40% increase in the number of disciplinary orders and a 5% increase in the number
of days to resolve a complaint. Each area of growth can be directly attributed to the increase in
registrants.
In late 2012, the New England Compounding Center in Massachusetts distributed a compounded
sterile preparation that was contaminated with a fungus. This product was distributed to 23
different states, including Texas. More than 751 individuals have become ill and as of January
2014, 64 patients who received injections of this contaminated product have died (only 2
individuals in Texas received the product and neither of these had serious reactions).
After learning of this serious issue in a sterile compounding pharmacy, TSBP conducted an
extensive review of the rules related to sterile compounding and the agency’s licensing, inspection,
and enforcement of these rules. During the 2013 Texas Legislative Session, with the assistance of
State Senator and Pharmacist Leticia Van de Putte, the agency was successful in obtaining
significant amendments to the Texas Pharmacy Act related to sterile compounding. These
amendments give the Board of Pharmacy the authority to:
inspect an out-of-state sterile compounding pharmacy and require them to pay for the
inspection;
require an inspection prior to opening a sterile compounding pharmacy;
specify a sterile compounding pharmacy may not renew unless it has been inspected as
required by the board and the pharmacy has reimbursed the Board for the costs of the
inspection; and
allow TSBP to accept an inspection report issued by the licensing board in the home state of
the pharmacy if:
o the board determines that the other state has comparable standards and regulations
applicable to sterile compounding pharmacies, including standards and regulations related
to health and safety; and
o the sterile compounding pharmacy provides to the board any requested documentation
related to the inspection. Strategic Plan – 2015-2019 External and Internal Issues
Texas State Board of Pharmacy 53 June XX, 2014
In addition, TSBP was successful in obtaining the authority and the funding to hire five new field
compliance inspectors and an additional administrative assistant to support these inspectors.
These additional five inspectors will bring the total number of inspectors to twelve and will allow
TSBP to inspect pharmacies that compound sterile preparations much more frequently to ensure
the safety of these facilities. The agency must continue to monitor pharmacies that compound
sterile pharmaceuticals closely to ensure that the pharmacies are preparing sterile compounds
properly.
In addition, on November 27, 2013, the U.S. Drug Quality and Security Act (Act) was signed into
law by President Obama. This law removes the unconstitutional provisions from section 503A of
the United States Food, Drug, and Cosmetic Act (FD&C Act) thereby making compounding
pursuant to a prescription a part of the FD&C Act. In addition, the law adds a new section 503B to
the FD&C Act. This new section allows facilities that are compounding sterile pharmaceuticals not
pursuant to individual prescriptions and “outsourcing” these products to other entities to be
registered as “outsourcing facilities” rather than as manufacturers. TSBP must monitor the
implementation of this act and the effect of the act on the current compounding provisions in the
Texas Pharmacy Act.
In order for the Board to continue to protect the citizens of Texas, it must have adequate funds and
staff. The almost 60,000 pharmacy technicians and trainees licensed by the agency have had a
dramatic effect on the agency’s operations. Of particular concern to the agency is the growth in the
number of disciplinary orders entered by the agency and the continuing growth in the number of
complaints received. Since FY2008, the agency has experienced a 5% increase in the number of
complaints; a 40% increase in the number of disciplinary orders and a 5% increase in the number
of days to resolve a complaint. Each area of growth can be directly attributed to the increase in
registrants.
In late 2012, the New England Compounding Center in Massachusetts distributed a compounded
sterile preparation that was contaminated with a fungus. This product was distributed to 23
different states, including Texas. More than 751 individuals have become ill and as of January
2014, 64 patients who received injections of this contaminated product have died (only 2
individuals in Texas received the product and neither of these had serious reactions).
After learning of this serious issue in a sterile compounding pharmacy, TSBP conducted an
extensive review of the rules related to sterile compounding and the agency’s licensing, inspection,
and enforcement of these rules. During the 2013 Texas Legislative Session, with the assistance of
State Senator and Pharmacist Leticia Van de Putte, the agency was successful in obtaining
significant amendments to the Texas Pharmacy Act related to sterile compounding. These
amendments give the Board of Pharmacy the authority to:
inspect an out-of-state sterile compounding pharmacy and require them to pay for the
inspection;
require an inspection prior to opening a sterile compounding pharmacy;
specify a sterile compounding pharmacy may not renew unless it has been inspected as
required by the board and the pharmacy has reimbursed the Board for the costs of the
inspection; and
allow TSBP to accept an inspection report issued by the licensing board in the home state of
the pharmacy if:
o the board determines that the other state has comparable standards and regulations
applicable to sterile compounding pharmacies, including standards and regulations related
to health and safety; and
o the sterile compounding pharmacy provides to the board any requested documentation
related to the inspection. Strategic Plan – 2015-2019 External and Internal Issues
Texas State Board of Pharmacy 53 June XX, 2014
In addition, TSBP was successful in obtaining the authority and the funding to hire five new field
compliance inspectors and an additional administrative assistant to support these inspectors.
These additional five inspectors will bring the total number of inspectors to twelve and will allow
TSBP to inspect pharmacies that compound sterile preparations much more frequently to ensure
the safety of these facilities. The agency must continue to monitor pharmacies that compound
sterile pharmaceuticals closely to ensure that the pharmacies are preparing sterile compounds
properly.
In addition, on November 27, 2013, the U.S. Drug Quality and Security Act (Act) was signed into
law by President Obama. This law removes the unconstitutional provisions from section 503A of
the United States Food, Drug, and Cosmetic Act (FD&C Act) thereby making compounding
pursuant to a prescription a part of the FD&C Act. In addition, the law adds a new section 503B to
the FD&C Act. This new section allows facilities that are compounding sterile pharmaceuticals not
pursuant to individual prescriptions and “outsourcing” these products to other entities to be
registered as “outsourcing facilities” rather than as manufacturers. TSBP must monitor the
implementation of this act and the effect of the act on the current compounding provisions in the
Texas Pharmacy Act.