Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Tuesday, July 1, 2014
FDA Outlines Guidance and Rules for Compounding Drug Products
FDA has outlined its guidance and rules for the compounding of drug products by releasing policy documents as part of the agency’s effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. The policy documents consist of a draft interim guidance, a proposed rule, a final guidance, and two revised requests for nominations for the bulk drug substances lists.
“Providing clarity to the compounding industry on the agency’s expectations for these unapproved drug products is a priority for the agency,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, in a press release. “These actions are essential next steps in providing the compounding industry with the appropriate tools to comply with the law and advancing the FDA’s efforts to continue protecting patients.”
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“Providing clarity to the compounding industry on the agency’s expectations for these unapproved drug products is a priority for the agency,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, in a press release. “These actions are essential next steps in providing the compounding industry with the appropriate tools to comply with the law and advancing the FDA’s efforts to continue protecting patients.”
continue to read here
Member Feedback Requested on Proposed Sterile Compounding Regulations
June 30, 2014 BJ Bartleson, RN, MS, NEA-BC
The California State Board of Pharmacy has produced a new draft of proposed regulations for pharmacies that compound or compound sterile preparations. The changes will be considered by the board for release for a 45-day comment period during its July 30 meeting. Many of the proposed regulations affect facility and equipment standards for sterile compounding such as ventilation, negative pressure and ante rooms. It is especially important for small, rural and critical access hospitals to review the proposed regulations. In the interest of developing the best regulations, the Board of Pharmacy has granted CHA an opportunity to submit feedback on physical plant modifications by July 9.
CHA Medication Safety Committee leaders — and others who worked together to compose extensive comments to the board’s original language in January — are analyzing the new regulations and drafting comments. In addition, CHA will host an all-member call on July 8 for interested hospitals to gather information and participate in discussion of the Board of Pharmacy changes, as well as CHA’s comments and proposal.
CHA encourages all members to compare the proposed physical and plant structural changes to current compounding facility and equipment standards and submit comments to CHA on the attached proposed worksheet and/or participate in the July 8 call:
Tuesday, July 8
4 p.m. – 5 p.m.
(800) 882-3610, Passcode 5968133#
Attached are CHA’s Jan. 10 comment letter, the Board of Pharmacy proposed language and a worksheet for submitting comments.
CHA Medication Safety Committee leaders — and others who worked together to compose extensive comments to the board’s original language in January — are analyzing the new regulations and drafting comments. In addition, CHA will host an all-member call on July 8 for interested hospitals to gather information and participate in discussion of the Board of Pharmacy changes, as well as CHA’s comments and proposal.
CHA encourages all members to compare the proposed physical and plant structural changes to current compounding facility and equipment standards and submit comments to CHA on the attached proposed worksheet and/or participate in the July 8 call:
Tuesday, July 8
4 p.m. – 5 p.m.
(800) 882-3610, Passcode 5968133#
Attached are CHA’s Jan. 10 comment letter, the Board of Pharmacy proposed language and a worksheet for submitting comments.
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