July 30, 2013
The Honorable Tom Harkin, Chairman
The Honorable Lamar Alexander, Ranking Member
The Honorable Pat Roberts
The Honorable Al Franken
The Honorable Barbara Mikulski
Senate Committee on Health, Education, Labor and Pensions
428 Senate Dirksen Office Building
Washington, DC 20515
Dear Chairman Harkin, Ranking Member Alexander, and Senators Roberts, Franken and Mikulski:
On behalf of the American Society of Health-System Pharmacists (ASHP), I am writing to express our
strong support for S. 959, the “Pharmaceutical Compounding Quality and Accountability Act” of 2013.
This bipartisan legislation will address the regulatory gaps that exist with respect to sterile compounding
and help prevent a tragedy such as the meningitis outbreak of 2012 from occurring in the future. In
addition, it will assure health-system pharmacists, physicians and other purchasers of compounded
products that compounding manufacturers have been inspected by the Food and Drug Administration
(FDA) and adhere to Current Good Manufacturing Practices.
ASHP is the national professional organization whose 40,000 members include pharmacists, pharmacy
technicians, and pharmacy students who provide patient care services in hospitals, health systems, and
ambulatory clinics. For 70 years, the Society has been on the forefront of efforts to improve medication
use and enhance patient safety.
S. 959 would create a new category of registration through the FDA for large scale commercial
compounders now referred to as compounding manufacturers. We believe this will close the regulatory
gap and jurisdictional uncertainty between FDA and state boards of pharmacy while maintaining state
oversight of the practice of pharmacy, which includes traditional pharmacy compounding.
Furthermore, we are pleased to see that hospitals and health systems—as purchasers of products from
compounding manufacturers—are treated as traditional compounders. Hospitals and health systems
are fully accountable for the comprehensive care of their patients and no medication, compounded or
otherwise prepared, is administered to the patient unless there is a patient-specific medication order.
Compounded medications prepared by hospital pharmacy departments and all other medications used
in health systems are prescribed or ordered based on established relationships with the medical staff.Senate Committee on Health, Education, Labor and Pensions
July 30, 2013
Page 2
We firmly believe this bipartisan legislation recognizes shifts in the current environment and provides
FDA oversight of a new type of large scale compounder that prepares sterile compounded products as a
service to hospitals and other providers who administer them to patients, rather than a traditional
pharmacy compounder who prepares sterile compounded products pursuant to a prescription, or in
limited quantities for anticipatory use. In addition, we are grateful the Committee recognized the
valuable role that traditional compounding pharmacies play in patient care, and that the bill keeps
traditional compounding pharmacies (including hospitals and health systems) under state board of
pharmacy purview.
Finally, ASHP strongly supports the exception for compounding commercially available products that are
on the FDA’s drug shortage list. Shortages of critical medications continue to present challenges as
caregivers scramble to obtain medications in short supply. We believe the allowance to compound
products in short supply will help address this challenge.
Again, ASHP thanks you for your leadership in addressing the regulatory gaps in non-patient specific
sterile compounding and ensuring that entities preparing sterile products and introducing them into
interstate commerce are properly inspected by and accountable to the FDA. We hope the full Senate
will consider this legislation soon and look forward to working with you and the full Congress to pass this
critical legislation. If you have any questions or need additional information, please contact Joseph Hill
on my staff at 301-664-8710 or jhill@ashp.org.
Sincerely,
Paul W. Abramowitz
Quoted from here
The Honorable Tom Harkin, Chairman
The Honorable Lamar Alexander, Ranking Member
The Honorable Pat Roberts
The Honorable Al Franken
The Honorable Barbara Mikulski
Senate Committee on Health, Education, Labor and Pensions
428 Senate Dirksen Office Building
Washington, DC 20515
Dear Chairman Harkin, Ranking Member Alexander, and Senators Roberts, Franken and Mikulski:
On behalf of the American Society of Health-System Pharmacists (ASHP), I am writing to express our
strong support for S. 959, the “Pharmaceutical Compounding Quality and Accountability Act” of 2013.
This bipartisan legislation will address the regulatory gaps that exist with respect to sterile compounding
and help prevent a tragedy such as the meningitis outbreak of 2012 from occurring in the future. In
addition, it will assure health-system pharmacists, physicians and other purchasers of compounded
products that compounding manufacturers have been inspected by the Food and Drug Administration
(FDA) and adhere to Current Good Manufacturing Practices.
ASHP is the national professional organization whose 40,000 members include pharmacists, pharmacy
technicians, and pharmacy students who provide patient care services in hospitals, health systems, and
ambulatory clinics. For 70 years, the Society has been on the forefront of efforts to improve medication
use and enhance patient safety.
S. 959 would create a new category of registration through the FDA for large scale commercial
compounders now referred to as compounding manufacturers. We believe this will close the regulatory
gap and jurisdictional uncertainty between FDA and state boards of pharmacy while maintaining state
oversight of the practice of pharmacy, which includes traditional pharmacy compounding.
Furthermore, we are pleased to see that hospitals and health systems—as purchasers of products from
compounding manufacturers—are treated as traditional compounders. Hospitals and health systems
are fully accountable for the comprehensive care of their patients and no medication, compounded or
otherwise prepared, is administered to the patient unless there is a patient-specific medication order.
Compounded medications prepared by hospital pharmacy departments and all other medications used
in health systems are prescribed or ordered based on established relationships with the medical staff.Senate Committee on Health, Education, Labor and Pensions
July 30, 2013
Page 2
We firmly believe this bipartisan legislation recognizes shifts in the current environment and provides
FDA oversight of a new type of large scale compounder that prepares sterile compounded products as a
service to hospitals and other providers who administer them to patients, rather than a traditional
pharmacy compounder who prepares sterile compounded products pursuant to a prescription, or in
limited quantities for anticipatory use. In addition, we are grateful the Committee recognized the
valuable role that traditional compounding pharmacies play in patient care, and that the bill keeps
traditional compounding pharmacies (including hospitals and health systems) under state board of
pharmacy purview.
Finally, ASHP strongly supports the exception for compounding commercially available products that are
on the FDA’s drug shortage list. Shortages of critical medications continue to present challenges as
caregivers scramble to obtain medications in short supply. We believe the allowance to compound
products in short supply will help address this challenge.
Again, ASHP thanks you for your leadership in addressing the regulatory gaps in non-patient specific
sterile compounding and ensuring that entities preparing sterile products and introducing them into
interstate commerce are properly inspected by and accountable to the FDA. We hope the full Senate
will consider this legislation soon and look forward to working with you and the full Congress to pass this
critical legislation. If you have any questions or need additional information, please contact Joseph Hill
on my staff at 301-664-8710 or jhill@ashp.org.
Sincerely,
Paul W. Abramowitz
Quoted from here