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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, April 1, 2014
Federal Register Vol. 79, No. 62 April 1, 2014 Notice Regarding Compounding Outsourcing Facilities Under Section 503B--Guidance on Fees
PDF]
7 hours ago - Compounding Outsourcing Facilities. Under Sections 503B and 744K of the. FD&C Act.'' The guidance is intended for entities that compound human drugs.
Federal Register/Vol. 79, No. 62/Tuesday, April 1, 2014/Notices
Question of the Day April 1, 2014 How many compounding pharmacies are using this or similiar systems?
ATTN: MED EFFECT INC MEMO-COMPOUNDING PHARMACY INDUSTRY-REGULATION-
Compounding pharmaceutical activities are coming under rapidly accelerating scrutiny from the FDA and USP797 due to the extremely unfortunate fungal meningitis out break at The New England Compounding Pharmacy and others such as Francks Compounding Pharmacy in Ocala, Fla., that also experienced a serious fungal outbreak.Direct regulation of the industry is inexorable and inevitable. Forward thinking, innovative companies are strategically planning for this scenario by implementing comprehensive decontamination protocols to preempt outbreaks at their facilities. Studies have shown that even the best terminal manual cleaning protocols only achieve a 40-60% reduction in residual bio-burden. Many companies are turning to hydrogen peroxide fogging systems such as the Sanosil Halo Fogging System.
Med Effect, Inc. offers the Sanosil Halo Hydrogen Peroxide Fogging System, which can be used for room/area or equipment decontamination. The Sanosil Halo Hydrogen Peroxide Fogging System is lightweight, portable, colorless, odorless, quiet, Eco friendly, effective, and economical.The Halo Fogging System assures a homogeneous mist of ionized particles that migrates to areas that regular cleaning can’t or don’t reach, to include high touch areas around doors, behind window treatments , and even under desks and beds. The Halo Fogging System will kill 99.99 % of bacteria, viruses, and fungi on pre-cleaned surfaces, without harming sensitive electronics, surfaces or substrates.
The Sanosil Halo Fogging System is EPA Registered, No. 84526-1. For additional information, please refer to our website at http://www.medeffect360.com and our industrial video at http://www.youtube.com/
Compounding pharmaceutical activities are coming under rapidly accelerating scrutiny from the FDA and USP797 due to the extremely unfortunate fungal meningitis out break at The New England Compounding Pharmacy and others such as Francks Compounding Pharmacy in Ocala, Fla., that also experienced a serious fungal outbreak.Direct regulation of the industry is inexorable and inevitable. Forward thinking, innovative companies are strategically planning for this scenario by implementing comprehensive decontamination protocols to preempt outbreaks at their facilities. Studies have shown that even the best terminal manual cleaning protocols only achieve a 40-60% reduction in residual bio-burden. Many companies are turning to hydrogen peroxide fogging systems such as the Sanosil Halo Fogging System.
Med Effect, Inc. offers the Sanosil Halo Hydrogen Peroxide Fogging System, which can be used for room/area or equipment decontamination. The Sanosil Halo Hydrogen Peroxide Fogging System is lightweight, portable, colorless, odorless, quiet, Eco friendly, effective, and economical.The Halo Fogging System assures a homogeneous mist of ionized particles that migrates to areas that regular cleaning can’t or don’t reach, to include high touch areas around doors, behind window treatments , and even under desks and beds. The Halo Fogging System will kill 99.99 % of bacteria, viruses, and fungi on pre-cleaned surfaces, without harming sensitive electronics, surfaces or substrates.
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