On September 2, Pew submitted comments to the U.S. Food and Drug Administration in response to draft guidance on the implementation of Title I of the Drug Quality and Security Act.
The comments highlight the need for more robust safeguards when compounding occurs on a larger scale and reference the Pew commissioned report “Ensuring the Safety of Compounded Drugs: Study highlights key quality standards.”
Download the PDF
September 2, 2014
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
20852
Re: FDA Draft Guidance: Current Good Manufacturing Practice — Interim Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act.
Dear Sir or Madam,
is an independent, nonpartisan research and policy organization dedicated to serving the public. Pew has a longstanding focus drug quality, including pharmaceutical compounding. We supported federal legislation to improve compounding oversight in 2013, and have conducted research and convened stakeholder summits.
In 2014 we commissioned a study that compares Current Good Manufacturing Practices (CGMPs), the standard applied to pharmaceutical companies, with Chapter 797, the standard used by compounding pharmacies. The study, Quality Standards for Large-Scale Sterile Compounding Facilities, authored by IQ LLC, highlights the more robust safeguards needed when compounding occurs on a larger scale.
We appreciate the opportunity to comment on FDA draft guidance on CGMPs for outsourcing facilities, which will be permitted to compound not pursuant to a patient prescription. Such facilities will register and submit to FDA oversight, maintain strict quality standards, and adhere to certain other requirements. This draft guidance provides a roadmap that will help outsourcing facilities understand how the agency intends for them to comply with CGMPs, and what standards are of particular importance to sterile compounding activities. This clarity is important for facilities that elect to join the new 503B regulatory category, which is voluntary, and will help support successful implementation.
continue to read here
The comments highlight the need for more robust safeguards when compounding occurs on a larger scale and reference the Pew commissioned report “Ensuring the Safety of Compounded Drugs: Study highlights key quality standards.”
Download the PDF
September 2, 2014
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
20852
Re: FDA Draft Guidance: Current Good Manufacturing Practice — Interim Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act.
Dear Sir or Madam,
is an independent, nonpartisan research and policy organization dedicated to serving the public. Pew has a longstanding focus drug quality, including pharmaceutical compounding. We supported federal legislation to improve compounding oversight in 2013, and have conducted research and convened stakeholder summits.
In 2014 we commissioned a study that compares Current Good Manufacturing Practices (CGMPs), the standard applied to pharmaceutical companies, with Chapter 797, the standard used by compounding pharmacies. The study, Quality Standards for Large-Scale Sterile Compounding Facilities, authored by IQ LLC, highlights the more robust safeguards needed when compounding occurs on a larger scale.
We appreciate the opportunity to comment on FDA draft guidance on CGMPs for outsourcing facilities, which will be permitted to compound not pursuant to a patient prescription. Such facilities will register and submit to FDA oversight, maintain strict quality standards, and adhere to certain other requirements. This draft guidance provides a roadmap that will help outsourcing facilities understand how the agency intends for them to comply with CGMPs, and what standards are of particular importance to sterile compounding activities. This clarity is important for facilities that elect to join the new 503B regulatory category, which is voluntary, and will help support successful implementation.
continue to read here
No comments:
Post a Comment