4/16/08 - The State of Wisconsin announces new requirements for credentialing of wholesale distributors of prescription drugs
12/12/07 - DHS Chemical Facility
Anti-Terrorism Standards, Appendix A
9/2407- Safety Advisory Notice
9/10/07 - CGA Regulatory Alert (RA-62), Safety Advisory Notice: Use of Mobile Acetylene Trailers
7/2/07 - Read the Bulletin on the Chemical Security Summit and the Homeland Security Regulation
3/1/07 - FDA publishes proposed changes in Medical Device Classification for Oxygen Regulators, including integrated valve & regulator devices.
3/9/07 - AAH-CGA-GAWDA Comments on Proposed Language for Medical Gases Guidance Document
3/6/07 - Worthington Cylinder Corporation has received a RECALL NOTICE from Norris Cylinder Company concerning certain A75-A420 size acetylene cylinders.
2/15/2007 - CGA Regulatory Alert (RA-49), USP Notice on Food Chemicals Codex
1/26/07 - IMPORTANT SAFETY NOTICE REGARDING MEDICAL OXYGEN CYLINDER
1/19/07 - GAWDA Needs Your Support - FDA Proposal - NDC CODE
1/4/07 - CGA Regulatory Alert (RA-43), Unauthorized Marking of Compressed Gas Cylinders
10/11/06 - “7 Most Common cGMP Violations”
9/19/06 - CGA Regulatory Alert (RA-33), HM-220F Final Rule
7/6/06 - The Cost Estimates of Compliance with the Proposed Rule
7/5/06 - After three months of diligent effort, GAWDA and CGA have developed and refined a detailed set of comments in response to FDA’s proposed new regulations for medical gas mix-ups. This 22 page GAWDA / CGA joint comments letter can be viewed here.
May 16, 2006 - Regulatory Update - Sealing Washers
4/26/06 - Medical Gas Alert
The Food and Drug Administration (FDA) and the National Institute for Occupational Safety and Health (NIOSH) have issued a joint safety alert regarding regulator fires on oxygen 870 series valves. The alert covers the seals (gaskets) used to prevent product from leaking between the valve outlet and the external regulator. The alert cautions users not to reuse these seals, and also cautions about the amount of torque applied to seal the gasket and the potential for the plastic crush type seals to cold flow and impinge on the gas flow, creating a potential for spontaneous ignition. Click here to download the safety alert.
FDA and NIOSH are encouraging medical gas firms to distribute this alert to their customers as a public service. If you have any questions about this alert please contact B&R Compliance Associates LLC.
4/26/06 - FDA and the Pharmaceutical industry have announced their 3rd annual Pharmaceutical Quality Systems Workshop, a joint FDA/Industry seminar.
Click Here To view the seminar agenda and registration form. For more information on past seminars, or help in deciding if attending this seminar is right for you, contact Bob Yeoman or Ron Ball at B&R Compliance Associates LLC at (610) 868-7183.
4/19/06 - FDA proposes new regulations on Medical Gas Container and Closures
3/1/06 - OSHA Issues Final Standard on Hexavalent Chromium
2/14/06 - Shipping Paper Retention ChangedEffective 1-9-2006, shippers must now retain a copy of the shipping paper for a period of two years after the shipping paper is offered. This was increased from the previous 375 days.
49 CFR 172.201 (e).
Contact Mike Dodd at 573-785-5111 or MLDSafety@hotmail.com with questions. |
