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To: James C. Boylan, Ph.D., Chairperson Executive Committee General Policies and Requirements Division, GPR United States Pharmacopeia Council of Experts Subject: Report of Parenteral Products – Compounding and PreparationCommittee (known informally as “The Sterile Compounding Committee”) From: David W. Newton, Ph.D., Committee Chairperson Dear Jim, Fellow GPR Chairpersons, and Sterile Compounding Committee Colleagues: I regret that neither I nor vice chair person David Driscoll are able to attend the November 17, 2003 GPR Division Executive Committee meeting. In lieu thereof, Isubmit this report on behalf of my Sterile Compounding Committee colleagues:Kathleen R. Anderson, Pharm.D. (FDA liaison); Samuel C. Augustine, Pharm.D.; GayleA. Brazeau, Ph.D.; David F. Driscoll, Ph.D., Vice Chair; Donald J. Filibeck, Pharm.D.;Kenneth L. Hughes, R.Ph.; Claudia C. Okeke, Ph.D. (USP liaison); Lawrence A. Trissel,R.Ph.; and James W. Wilson, R.Ph.
Recommendations_ The Council of Experts Committee currently titled “Parenteral Products –Compounding and Preparation” should be officially retitled “Sterile Compounding” _ USP should maintain an expert committee of pharmacists with substantial sterilecompounding experience with the charge to ensure that Chapter <797> PharmaceuticalCompounding – Sterile Preparations, or whatever USP document that <797> maybecome, retains safe and practicable content, which compounders will apply; not neglect.
Every member of the 2000-present Sterile Compounding Committee is a pharmacist.
_ USP preparation and testing requirements for compounded sterile preparations shouldnot become commensurate with those for manufactured sterile drugs and nutrientsproduced in large lots.a, b Such requirements could (1) deprive effective and humanecare to unique patients whose therapists prescribe special non-manufactured drug andnutrition therapy in limited amounts and durations, and (2) create marketing advantagefor large providers of compounded sterile preparations.
_ USP employee leaders should urgently determine an efficient and inexpensiveprocedure for pharmaceutical compounders and state boards of pharmacy to access orpossess all USP chapters, monographs, and other information related directly topharmaceutical compounding practice.
DWN’s J:\USP files\Report for Nov 2003 GPR Exec Meeting.doc-1 June – October, 2003 Events and Related Comments USP chapter <797> published in the July-August, 2003 Pharmacopeial Forum shall become official January 1, 2004. During summer 2003, Dave Newton was aninvited guest at meetings of the USP Analytical Microbiology, and Industrial ParenteralsExpert Committees. The membership of those Committees is predominantly industrialand federal regulatory pharmaceutical scientists, some of whom (a) criticized <797> forinsufficient or absent standards, (b) questioned the need for sterile compounding at all,and (c) perceived <797> as promoting the practice of sterile compounding.
The first concise U.S. information sources specifically for sterile pharmaceutical compounding were ASHP’s 1993 Guidelinesc and USP’s 1995 Chapter <1206> SterileProducts for Home Use.d Long before those documents, physicians relied on localpatient-dedicated, risk-taking hospital pharmacists to compound injections that wereneeded to improve medical and surgical care, for example, phenytoin and nitroglycerin,ewhich subsequently became manufactured products. Sterile compounding preceded, andwould proceed in the absence of, any pertinent USP chapters and monographs.
In early October, 2003 Dr. Okeke received from a pharmacy compounding business a 12-paged list of 30 recommended changes to <797> as published in July-August, 2003 Pharmacopeial Forum. Requests to alter <797> may be expected to rangefrom more lenient to more rigorous requirements, which forecast the USP norm ofcontinual revision – “The road to success is always under construction.” The impetus to transform <1206> to a chapter numbered less than 1000, i.e., from informational to FDA-enforceable status, stemmed from FDA’s July 13 and 14, 2000Pharmacy Compounding Advisory Committee meeting. That meeting resulted in FDA’sAugust, 2001 Concept Paper pertaining to section 127 in the 1997 FDA ModernizationAct or FDAMA, from which the following is a verbatim excerpt, excluding content in{ } added by Dave Newton: “FDAMA section 127 amended the {1938} Federal Food, Drug, and Cosmetic Act (the act) by adding section 503A (21 U.S.C. 353a), which governs the application ofFederal law to pharmacy compounding. Under section 503A(a) of the act, a compoundeddrug product is a drug product made in response to, or in anticipation of, receipt of avalid prescription order or a notation on a valid prescription order from a licensedpractitioner that states the compounded product is necessary for the identified patient.
“Compounded drug products are exempt … from three key provisions of the act…(1)Adulteration provision of section 501(a)(2)(21 U.S.C. 351(a)(2)(B)) (current goodmanufacturing practice (CGMP) requirements); (2) misbranding provision of section502(f)(1) (21 U.S.C. 352(f)(1)) (labeling of drugs with adequate directions for use); and(3) new drug provision of section 505 (21 U.S.C. 355) (…use of drugs under … INDs …NDAs …. ANDAs). … drug products that “present demonstrable difficulties forcompounding that reasonably demonstrate adverse effect on the safety or effectiveness ofthat drug product” (section 503A(b)(3) of the Act) {include}… All sterile products thatare compounded under procedures other than those described in Chapter 1206 [“SterileDrug Products for Home Use”] of the United States Pharmacopeia (USP)”f DWN’s J:\USP files\Report for Nov 2003 GPR Exec Meeting.doc-2 On April 29, 2002, the U.S. Supreme Court declared section 503A of FDAMA invalid in its entirety, because it “contained unconstitutional restrictions on commercialspeech (i.e., prohibitions on soliciting prescriptions for and advertising specificcompounded drugs).”g The challenging process to transform <1206> to current <797> began in fall, 2000 and culminated with two 2-day full attendance meetings in Rockville, MD in fall,2002 (one during the sniper attacks in October). The results of this revision process werepublished in the following Pharmacopeial Forum issues: Vol. 28(2) [Mar.-Apr. 2002]:498-534.
Vol. 29(3) [May-June 2003]:750-809.
Vol. 29(4) [July-Aug. 2003]:940-965.
During summer, 2003 USP laboratory renewed interest in studying glycerin andhydrochloric acid injections monographs first submitted in 2001 by the SterileCompounding Committee.
The Sterile Compounding Committee will have at least one meeting on a yet to be determined 2004 date to address comments received regarding changes to <797>, andconsider sterile compounding monographs.
Footnotes aAppendix. Selected Attributes of Compounded versus Manufactured Drugs.
public health risk from small: few people exposed 1942 Injections, and 1975 solidoral dosage forms dissolution test bJanet Heinrich, Director, Health Care-Public Health Issues, U.S. GeneralAccounting Office, October 23, 2003 report titled, State and Federal Oversight of DrugCompounding by Pharmacies. “The agency [FDA] recognized in its brief…in 2002Supreme Court case…that applying FDCA’s [Food, Drug and Cosmetic Act] new drugapproval requirements to drugs compounded on a small scale is unrealistic – that is, not…feasible to require drug compounding pharmacies to undergo testing for new drugapproval process for drugs compounded to meet the unique needs of individual patients.”http://www.gao.gov/new.items/d04195t.pdf. Accessed 10-28-2003 by Dave Newton.
DWN’s J:\USP files\Report for Nov 2003 GPR Exec Meeting.doc-3 cASHP technical assistance bulletin on quality assurance for pharmacy-preparedsterile products. American Journal of Hospital Pharmacy. 1993; 50 (November):2386-98.
d Evolution of the United States Pharmacopeia Chapter <1206>: “Sterile Preparations – Pharmacy Practices.” International Journal of PharmaceuticalCompounding. 2001; 5 (July/August): 265-7.
e • Phenytoin Injections: From Compounding to Cerebyx. International Journal of Pharmaceutical Compounding.2002; 6 (November/December): 410-3.
• Nitroglycerin Injection (letter). American Journal of Hospital Pharmacy. 1970;27 (November): 883 f www.fda.gov/cder/fdama/difconc.htm, FDA Concept Paper: Drug Products That Present Demonstrable Difficulty for Compounding Because of Reasons of Safety orEffectiveness. Accessed 10-27-2003 by Dave Newton.
g http://www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg460-200.html. Accessed _______________________________________________________________________ This document was originally distributed October 28, 2003 via email attachment fromDave Newton to Jim Boylan, Loyd V. Allen, Jr.; and Dave’s Sterile CompoundingCommittee colleagues.
DWN’s J:\USP files\Report for Nov 2003 GPR Exec Meeting.doc-4

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