Legal and Public Affairs Update
John Sullivan
As we move through spring and enjoy the change in the weather there are a few items I wanted inform and/or remind our members about. The first item is to remind us all that compounded drug products must be pursuant to a patient specific prescription order. Drug items compounded for "office use" and not patient specific are considered to be manufacturing by both Federal and State law. Only registered outsourcing facilities may compound for office use. A list of registered pharmacies can be found at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm378645.htm.
The board of pharmacy is enforcing this for all sterile compounded products, so ensure that your practices are following current law.
Another item related to compounding is the proposed USP General Chapter 800 related to compounding of Hazardous Drugs. There is an open comment period available through July 31, 2014. You can view the proposed chapter by following the link: http://www.usp.org/usp-nf/notices/compounding-notice. This chapter applies to all personnel who are involved in handling hazardous drugs including those not in your pharmacy departments. I encourage all of you that handle hazardous drugs to review the chapter and follow the instructions listed on the website should you have any comments.
quoted from ISHP May 2014 Newsletter
John Sullivan
As we move through spring and enjoy the change in the weather there are a few items I wanted inform and/or remind our members about. The first item is to remind us all that compounded drug products must be pursuant to a patient specific prescription order. Drug items compounded for "office use" and not patient specific are considered to be manufacturing by both Federal and State law. Only registered outsourcing facilities may compound for office use. A list of registered pharmacies can be found at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm378645.htm.
The board of pharmacy is enforcing this for all sterile compounded products, so ensure that your practices are following current law.
Another item related to compounding is the proposed USP General Chapter 800 related to compounding of Hazardous Drugs. There is an open comment period available through July 31, 2014. You can view the proposed chapter by following the link: http://www.usp.org/usp-nf/notices/compounding-notice. This chapter applies to all personnel who are involved in handling hazardous drugs including those not in your pharmacy departments. I encourage all of you that handle hazardous drugs to review the chapter and follow the instructions listed on the website should you have any comments.
quoted from ISHP May 2014 Newsletter
No comments:
Post a Comment