Montana Department of Public Health and Human Services Drugs to be reviewed on October 27, 2004 NOTE: this listing is a list of drugs that will be discussed at the next Montana Medicaid DURB Formulary Meeting. The order of drugs and their grouping within specific clinical classes may vary in presentation STATINS ADVICOR ALTOPREV formerly Altocor ; LESCOL LESCOL XL LOVASTATIN MEVACOR PRAVACHOL PRAVIGARD PAC HIGH POTENCY STATINS LIPITOR ZOCOR CRESTOR COMBO STATIN CAI VYTORIN LIPOTROPICS: CAI ZETIA COX II INHIBITORS BEXTRA CELEBREX ACE INHIBITORS ACCUPRIL ACEON ALTACE CAPOTEN CAPTOPRIL ENALAPRIL MALEATE LISINOPRIL LOTENSIN BENAZEPRIL HCL MAVIK ACE INHIBITORS con't ; MOEXIPRIL HCL MONOPRIL FOSINOPRIL SODIUM PRINIVIL UNIVASC VASOTEC ZESTRIL ACE INHIBITOR DIURETIC COMBINATIONS ACCURETIC QUINARETIC BENAZEPRIL HCL-HCTZ CAPOZIDE CAPTOPRIL HYDROCHLORO THIAZIDE ENALAPRIL MALEATE HCTZ LISINOPRIL-HCTZ LOTENSIN HCT MONOPRIL HCT PRINZIDE UNIRETIC VASERETIC ZESTORETIC ACE INHIBITOR CALCIUM CHANNEL BLOCKER LEXXEL LOTREL TARKA COMBINATION HMG-COA REDUCTASE INHIBITOR and DHPCCB CADUET DIHYDROPYRIDINE CALCIUM CHANNEL BLOCKERS ADALAT ADALAT CC AFEDITAB CR CARDENE CARDENE SR DYNACIRC DYNACIRC CR NICARDIPINE HCL NIFEDICAL XL NIFEDIPINE ER NIFEDIPINE I.R. NIFEDIPINE TABLET SA NIFEDIAC CC NORVASC PLENDIL PROCARDIA PROCARDIA XL SULAR NONDIHYDROPYRIDINE CCB'S CALAN CALAN SR CARDIZEM CARDIZEM CD CARDIZEM LA CARDIZEM SR CARTIA XT COVERA-HS DILACOR XR DILT-CD DILTIA XT DILTIAZEM ER DILTIAZEM HCL DILTIAZEM XR ISOPTIN ISOPTIN S.R. NONDIHYDROPYRIDINE CCB'S con't ; TAZTIA XT TIAZAC VERAPAMIL HCL VERELAN VERELAN PM BETA BLOCKERS ACEBUTOLOL HCL ATENOLOL BETAPACE BETAPACE AF BETAXOLOL HCL BISOPROLOL FUMARATE BLOCADREN CARTROL COREG CORGARD INDERAL INDERAL LA INNOPRAN XL KERLONE LABETALOL HCL LEVATOL METOPROLOL TARTRATE NADOLOL NORMODYNE PINDOLOL PROPRANOLOL HCL SECTRAL SORINE SOTALOL, SOTALOL HCL TENORMIN TIMOLOL MALEATE TOPROL XL TRANDATE ZEBETA. Correspondence comments should be marked for the attention of: the pharmacovigilance section, irish medicines board, earlsfort centre, earlsfort terrace, dublin 2.

For pour-on product in the east, a comparable pattern for large volume container non-Ivomec product is observed. The Canadian price of nonIvomec product is significantly lower than the U.S. "high cost" non-Ivomec product for all container sizes; but the U.S. price of "low cost" large volume container 5 litre ; brands is significantly lower than the Canadian price of generic product. For injectable product in the east, the price of smaller or 500 ml Ivomec is significantly higher in Canada; but the price of larger volume 1000 ml nonIvomec is significantly lower in Canada.
A3. Autoimmune adrenalitis accounts for over 70% of cases of Addison's disease in the western world. Pathologically, the adrenal glands are atrophic, with loss of most of the cortical cells, but the medulla is intact. In 75% of cases, adrenal autoantibodies can be detected. Fifty per cent of patients with this form of Addison's disease have an associated autoimmune disease, thyroid disease being the most common. A4. Renal impairment, hypotnatraemia, hyperkalaemia, hypercalcaemia, hypoglycaemia. Our patient had an elevated urea and normal creatinine in keeping with his dehydration. With prolonged hypotension greater degrees of renal impairment may develop. This patient was hyponatraemic and hyperkalaemic, which is typical in primary hypoadrenalism. Hyponatraemia is due to impaired renal dilutional capacity and in addition ADH levels are elevated resulting in increased free water retention. Hyperkalaemia, not seen in secondary hypoadrenalism, is due to aldosterone deficiency with resultant renal sodium loss and diminished renal potassium excretion. Hypercalcaemia can sometimes occur probably due to haemoconcentration. Hypoglycaemia may develop as cortisol regulates expression of enzymes involved in gluconeogenesis. A5. The goals of therapy in adrenal crisis are treatment of hypotension and reversal of electrolyte abnormalities and of cortisol deficiency. Large volumes two to three litres ; of 0.9% saline solution should be quickly infused intravenously. Hypotonic saline should not be used because it can worsen the hyponatraemia. Glucocorticoid deficiency should be treated by immediate intravenous injection of a soluble form of cortisol such as 100mg hydrocortisone sodium succinate and should be given every six to eight hours for the first 24 hours. Mineralocorticoid replacement is less useful acutely because it takes several days for its sodium-retaining effects to become apparent and adequate sodium replacement can be achieved by intravenous saline alone. Unless there is a major complicating illness, parenteral glucocorticoid therapy can be tapered over one to three days and changed to an oral maintenance dose. Any precipitating cause such as infection should be treated. Most patients who present with adrenal crisis have primary adrenal insufficiency and therefore require lifelong glucocorticoid and mineralocorticoid therapy. A6. Replacement of corticosteroid and mineralocorticoid. The average daily secretion rate of cortisol in normal subjects is 10-20mg day 27.5-55mol day ; . Therefore, in maintenance treatment, cortisone acetate 25-37.5mg day ; or hydrocortisone 20-30mg day ; tablets are. There were no votes opposed and no abstentions. 9 ; Beta Blockers High Blood Pressure and Heart Failure ; a ; Review clinical literature was presented. Mr. Mergener noted the Oregon project's review concurred with Ms. Taylor's review of the Beta Blockers class, specifically mentioning the conclusions with Coreg. b ; Recommendation: Acebutolol, atenolol, betaxolol, bisoprolol, labetalol, metoprolol, nadolol, pindolol, propranolol, sotalol, timolol, Coreg, Toprol as preferred. Cartrol, Inderal LA, Innop5an XL, Levatol as non-preferred. c ; Discussion: Dr. Hirsch asked Ms. Taylor when Coreg is going generic. Ms. Taylor replied that she did not know and would research and report back to the committee. Dr. Hirsch asked Ms. Taylor if there were any clinical reasons why betaxolol and bisoprolol should be included as preferred products given their relative cost as generics in the class. Ms. Talyor indicated that there were not any unique clinical advantages provided by the two generics. d ; Motion Dr. Hirsch made a motion to accept the recommendations with the exception that betaxolol and bisoprolol should be recommended as non-preferred, and that the patients currently using one of the recommended non-preferred drugs be grandfathered. Dr. Fedderly seconded the motion. e ; Vote on Motion Voting in favor were: ! ! ! Tom Frazier aye Steve Maike aye Bradley Fedderly - aye ! ! ! Peg Smelser aye James Heersma aye Tom Hirsch aye.

Free Innopran Alt Item: INNOPRAN XL CAP 80mg 100 Recommended SKU for B: BENI40125 pot. savings ##TEXT## BENICAR HCT 40 12.5mg ann. Rx 19 ann. units per. Rx 8 per. units Inv min 69 Inv Max and atacand. Drug Name GUAIFENEX PSE 85 TAB ENTSOL NASAL WASH PACKETS AMEVIVE 15 mg VIAL LEXAPRO 5 mg 5 ml SOLUTION AVAR GEL AVAR GREEN GEL NOVOLOG MIX 70 30 VIAL MAXI-TUSS HCX LIQUID TUSANA-D LIQUID ADOXA 75 mg TABLET ADOXA PAK 1 75 mg TABLET CRESTOR 10 mg TABLET CRESTOR 20 mg TABLET CRESTOR 40 mg TABLET URSODIOL POWDER AZASAN 75 mg TABLET AZASAN 100 mg TABLET RISPERDAL 1 mg M-TAB RISPERDAL 2 mg M-TAB CARDIZEM LA 120 mg TABLET CARDIZEM LA 180 mg TABLET CARDIZEM LA 240 mg TABLET CARDIZEM LA 300 mg TABLET CARDIZEM LA 360 mg TABLET CARDIZEM LA 420 mg TABLET ANAMANTLE HC CREAM LIDAZONE HC 3-0.5% CREAM LIDOCAINE-HC 3-0.5% CREAM DIFIL-G TABLET FINACEA 15% GEL CECON 90 mg ml DROPS RESTASIS 0.05% EYE EMULSION SIMULECT 10 mg VIAL LOPROX 1% SHAMPOO ELIGARD 30 mg SYRINGE FIBER LAXATIVE CAPSULE FIBER THERAPY CAPSULE GENFIBER CAPSULE MEDI-MUCIL CAPSULE METAMUCIL CAPSULE QC FIBER CAPSULE REGULOID CAPSULE SUNMARK FIBER LAXATIVE CAPS BUSPIRONE HCL POWDER FORMULATION R SUPPOSITORY LUBRIDERM DAILY SPF 15 LOTI REGENECARE WOUND GEL CPM 8 PE 20 MSC 1.25 mg TAB DURAHIST PE TABLET HISTATAB PH TABLET RAPAMUNE 2 mg TABLET THALOMID 200 mg CAPSULE CEFAZOLIN 1 GM-DEXTROSE BAG FUZEON CONVENIENCE KIT CORFEN-DM LIQUID ED-A-HIST DM LIQUID NOREL DM LIQUID TRITAL DM LIQUID INNOPRAN XL 120 mg CAP SA OXYTROL 3.9 mg 24HR PATCH EMEND 80 mg CAPSULE EMEND 125 mg CAPSULE SMAC PA Required Covered for duals yes yes no no no yes yes no no no yes no PA Required no no PA Required no yes yes yes yes yes yes yes yes no yes PA Required no no no 1795 no yes yes yes yes no no no Generic Sequence Nbr 51661 51672 51694. Vaccination is the term used to refer to the administration of any vaccine or toxoid. Reporting of Adverse Reactions and Quality Defects All suspected adverse reactions should be reported to the Irish Medicines Board, Block A, Earlsfort Centre, Earlsfort Terrace, Dublin 2, using the Yellow Card System. This is a "Freepost" system and cards are available from the Irish Medicines Board at the above address. Reports should be as detailed as possible and should include the batch number of the vaccine. A copy of the adverse reaction report form may also be downloaded from the Irish Medicine Board's website at : imb.ie. Completed forms should be posted in envelopes marked "Freepost" and sent to the above address. Quality defects are also monitored by the Irish Medicines Board, using a similar "Freepost" Green Card System. Quality defects include missing labels label texts, container defects, altered product appearance, particles in product etc. Full details of the defect and the batch number should be given on the Green Card. Cards are available from the Irish Medicines Board at the above address. The National Disease Surveillance Centre, 25 - 27 Middle Gardiner Street, Dublin 1 ndsc.ie ; is responsible for the surveillance of communicable diseases, examining the incidence of vaccine-preventable illness and examining trends in the uptake in vaccines. This document is available on the RCPI Department of Health and Children websites. The electronic version of the document will be regularly updated as changes are introduced to our immunisation schedule. Web-sites with further information about immunisation For further information and debate on immunisation the following web-sites may be useful and lopid.

Innopran oral 57 ; Abstract: To more efficiently provide CPT, which is a starting compound for irinotecan hydrochloride and various camptothecin derivatives, by a practically usable total synthesis, a means whereby 2'-amino-5'hydroxypropiophenone corresponding to the AB cycle moiety of the camptothecin CPT ; skeleton and a tricyclic ketone corresponding to the CDE cycle moiety thereof can be efficiently produced and thus CPT and its derivatives can be stably supplied is provided. Figure: NIL. Use that momentum to make a difference because I think we all have the power, everybody here has already done a great deal in their careers to deal with this epidemic and I think together we can even do more. So, a few household announcements, obviously thanking you for your participation, you have earned a cocktail hour, we will begin momentarily outside. It is going to be in the and lotensin. To sustain our continued growth, we will need to increase the size of our organization, and we may encounter difficulties managing our growth, which could adversely affect our results of operations. If we are able to successfully develop additional products and extend the use of our current products, we may experience growth in the number of our employees and the scope of our operations. To the extent that we acquire and launch additional products, the resulting growth and expansion of our sales force will place a significant demand on our financial, managerial and operational resources. Since many of the new products or systems we are working on may involve new technologies or entering new markets, we may not be able to accurately forecast the number of employees required and the timing of their hire or the associated cost. The extent of any expansion we may experience will be driven largely by the success of our new products and systems. As a result, management's ability to project the size of any such expansion and its cost to the company is limited by the following uncertainties: i ; we will not have previously sold any of the new products and technologies and the ultimate success of these new products and technologies is unknown; ii ; we will be entering new markets; and iii ; the costs associated with any expansion will be partially driven by factors that may not be fully in our control e.g., timing of hire, market salary rates ; . As of December 31, 2007, subject to these uncertainties, we believe that our current business plan may require us to hire between 30 and 40 new employees within the next 12 months at an incremental cost of between .6 million and .5 million. Due to the uncertainty surrounding the new product lines, this estimate may prove to be incorrect, and our costs could be significantly higher. Our success will also depend on the ability of our executive officers and senior management to continue to implement and improve our operational, information management and financial control systems, particularly in light of our status as a public company subject to the reporting requirements of the Securities Exchange Act of 1934, or the Exchange Act, and to expand, train and manage our employee base. Our inability to manage growth effectively could cause our operating costs to grow even faster than we are currently anticipating and adversely affect our results of operations. Because we have limited research and development capabilities, we will be dependent on third parties to perform research and development for us. We have limited internal research and development capabilities and currently outsource all of our product research and development to third-party research labs. In particular, we have licensed technologies that may issue as patents under certain patent applications filed by JR, and have relied heavily on services provided by JR in the development of new products to address acne and skin elasticity. We have received sufficient support from our third-party research labs to drive our current new product development, and we expect to continue to rely on third parties to research and develop new products. There are a limited number of third-party research and development companies that specialize or have the expertise required to achieve our product development objectives. As a result, it may be difficult for us to engage research and development labs and personnel for our anticipated future needs. If we are unable to arrange for third-party research and development of our products, or to do so commercially reasonable terms, we may not be able to develop new products or expand the application of our existing products. Reliance on third-party research and development labs entails risks to which we would not be subject if we performed the research and development ourselves. These risks include reliance on the third party for maintaining the confidentiality of the proprietary information relating to the product being developed and for maintaining quality assurance, the possibility of breach of the research and development agreement by the third party, and the possibility of termination or non-renewal of the agreement by the third party.

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I.e., parallel to the C2 symmetry axis of the molecule ; . Analyses of these spectra proceeded in a manner similar to the previously described origin band. In the case of the + 422 band see Figure 3.3 ; , ~5300 b-type rovibronic transitions were simulated. Of these, ~200 lines were assigned and fit using rigid rotor Hamiltonians for both electronic states. In the bottom panel of Figure 3.3, the experimental trace and the corresponding simulations, with and without a lineshape function are also shown. The OMC of the fit is ~1.49 MHz, the lineshape Voigt profile has ~3 MHz Gaussian and ~2 MHz Lorentzian contributions. The rotational temperature of the fit is ~8 K. For the + 431 and + 434 bands see Figure 3.4 ; , ~220 lines out of ~7500 were assigned, resulting in standard deviations of ~1.5 MHz; the rotational temperatures of the fits are ~9.5 and ~17 K, respectively. Voigt profile components similar to those used in the + 422 band were used in these fits. The 38.

Drugs for the control of chronic long-term ; conditions. Includes brand and generic drugs that treat cancer, heart disease, and multiple sclerosis. Heart medications, cholesterol-lowering medications, estrogen, and oral diabetic drugs are in this group. ACCUPRIL ACTIVELLA ACTONEL ACTOS ADVICOR ALLOPURINOL ALTACE ALTOPREV AMARYL ANDROGEL ASACOL ATACAND ATACAND HCT ATENOLOL AVALIDE AVANDAMET AVANDIA AVAPRO AVONEX AZATHIOPRINE BENICAR BENICAR HCT BENAZEPRIL BENAZEPRIL HCTZ BISOPROLOL HCTZ CADUET CAPTOPRIL CARDIZEM LA CARTIA XT CENESTIN CLIMARA CLONIDINE HCL COZAAR CRESTOR DIGITEK DILTIAZEM HCL DIOVAN DIOVAN HCT DOXAZOSIN MESYLATE ENALAPRIL MALEATE ENBREL ESTRACE ESTRADIOL tablet ESTRATEST ESTROPIPATE EVISTA FEMHRT FORTAMET FOSAMAX FOSINOPRIL SODIUM FOSRENOL FUROSEMIDE GEMFIBROZIL GLIPIZIDE GLIPIZIDE ER GLIPIZIDE XL GLUCOPHAGE GLUCOPHAGE XR GLUCOTROL XL GLUCOVANCE GLYBURIDE GLYBURIDE METFORMIN HYDROCHLOROTHIAZIDE HYZAAR INDAPAMIDE INDERAL LA INNOPRAN XL ISOSORBIDE DINITRATE LANOXIN LESCOL LESCOL XL LEVOXYL LIPITOR LISINOPRIL LOTENSIN LOTENSIN HCT LOTREL LOTRONEX LOVASTATIN MEDROXYPROGESTERONE tablet MENOSTAR MERCAPTOPURINE METAGLIP METFORMIN HCL METHOTREXATE METOPROLOL MEVACOR MICARDIS MICARDIS HCT MONOPRIL NADOLOL NIASPAN NIFEDIPINE NIFEDIPINE ER NITROQUICK NORVASC PLENDIL PRAVACHOL PRAVIGARD PAC PREMARIN PREMPHASE PREMPRO PREMPRO Low Dose PROMETRIUM PROPRANOLOL PURINETHOL RIOMET RYTHMOL SR SENSIPAR SPIRONOLACTONE STRIANT SYNTHROID TAMOXIFEN TARCEVA TARKA TERAZOSIN capsule TESTIM TEVETEN TEVETEN HCT TOPROL XL TRIAMTERENE HCTZ TRICOR VERAPAMIL VIVELLE-DOT 0.05mg PATCH VYTORIN WELCHOL XALATAN ZESTORETIC ZESTRIL ZETIA ZOCOR and mevacor.
Disappear in 48 percent of patients, compared with 13 percent of patients who received only chemo. A pivotal study published in the Lancet found that dialysis patients given erythropoiesis-stimulating agents 1 to 3 times a week were switched to monthly doses of methoxy polyethylene glycolepoetin beta Mircera ; without loss of hemoglobin concentrations At a 100-mg dose, AstraZeneca's oral cancer drug.
456. Spatial neglect during electrocortical stimulation mapping in the right hemisphere - Kleinman J.T., Sepkuty J.P., Hillis A.E. et al. [N.E. Crone, Department of Neurology, Johns Hopkins Hospital, 600 N. Wolfe Street, Meyer 2-147, Baltimore, MD 21287, United States] - EPILEPSIA 2007 48 12 ; - summ in ENGL Spatial processing was assessed following implantation of subdural electrodes in the nondominant hemisphere with electrocortical stimulation mapping ESM ; in two patients before epilepsy surgery. Section 50 vol 41.2 and micardis. Estimate high pressure jet drilling rates at 75 kW shown in Figure 13. The drilling rates were corrected for rotary speed using equation 2. averages 12 m hr and ranges from 5 to 33 hr. most cases. At 70 MPa jet pressure, the projected drilling rate Since most reservoir rock has substantially higher.

In HIV-infected patients, liver disease relevancies clinically relevant, especially with regard to the management of antiretrovirals. These drugs can induce hepatic toxicity and should be managed with special care in patients suffering from liver disease. Similarly, they can present interactions with drugs indicated in the treatment of liver disease or, as is the case with 3TC, FTC and tenofovir, they can have antiviral activity against hepatotropic viruses which must be taken into account when prescribing and zocor. Literature on Campylobacter on the whole are quite extensive and have been described quite thoroughly for past two decades. Countries such as the United States, Japan and all over Europe have most of their outbreaks and sporadic incidences of Campylobacter well documented due to the availability of good reporting systems in place. Unfortunately, in South Africa, fatalities and mortalities due to diseases often go unreported and as such much important information is lost. It therefore becomes difficult to substantiate exactly how many individuals are affected by gastroenteritis in this country each year. Nevertheless, individuals that are highly impoverished, and with obvious weakened immune systems are more susceptible to gastrointestinal infections. Based on this.
10000 mg kg bw GLP: no as prescribed by 1.1 1.4 Five male New Zealand White albino rabbits were exposed to the undiluted substance for 24 h using a covered application to the clipped unabraded skin. No signs of intoxication or mortalities were observed for 14 days. Skin irritation consisted of fissuring, desquamation and coriaceousness. Rabbits were noted pulling fur out. No gross pathology was observed at gross autopsy. The LD50 was reported to be 10000 mg kg probably based on density 1.1 g ml ; . CYTEC INDUSTRIES B.V. Rotterdam 13 and accupril.

All staff who provide care to residents with suspected or confirmed pulmonary tuberculosis must: 1. Receive PPD skin testing at least annually. Skin testing may be done at more frequent intervals if deemed necessary INFECTION CONTROL GUIDELINES FOR LONG TERM CARE FACILITIES. TABLE 4. Strategies for Optimizing the Listening-Learning Environment for Children With OME and Hearing Loss * Get within 3 feet of the child before speaking. Turn off competing audio signals such as unnecessary music and television in the background. Face the child and speak clearly, using visual clues hands, pictures ; in addition to speech. Slow the rate, raise the level, and enunciate speech directed at the child. Read to or with the child, explaining pictures and asking questions. Repeat words, phrases, and questions when misunderstood. Assign preferential seating in the classroom near the teacher. Use a frequency-modulated personal- or sound-fieldamplification system in the classroom. * Modified with permission from Roberts et al.78, 79 and plavix and Innopran online.

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Childhood ALL therapy typically consists of phases; remission-induction, post-remission or consolidation and maintenance. CNS directed therapy or CNS sanctuary therapy is received prophylactically by ALL patients at varying intensities throughout the different stages of therapy until the end of maintenance. This therapy aims to inhibit the infiltration of blasts into the CNS, to eliminate those that habour or sequester in the CNS and prevent the formation of secondary tumours. The described treatment protocol is only a framework for childhood ALL therapy upon which a myriad of clinical trials have been based, with alterations to drug combinations, concentrations and administration methods and timing.
Reducing tobacco use; increasing physical activity; eating healthy. The overall theme of these guidelines is "you can protect yourself today through smart everyday choices." And when it comes to nutrition, there are no mixed messages. All three groups know the words to the song: You can "fortify your health with a nutritious diet." These same simple messages are included in the Dietary Guidelines for Americans. These guidelines are reviewed and revised every five years. A group of experts is appointed to look at the latest nutrition research and put together key messages to Americans about how to eat in order to stay healthy. Though these guidelines are meant for the general public, the report notes that the dietary guidelines can be used by the many people with weight problems, high blood pressure, abnormal blood fats and diabetes. Revised CPGM list on 12 18 2003 by added new Drugs program 7356.002M, ``Inspections of Licensed Biological Therapeutic Drug Products'' added new Veterinary Medicine program 7371.009, ``BSE Ruminant Feed Ban Inspections'' added on-line links for Drug programs: 7346.832 ``Pre-Approval Inspections Investigations''; 7346.843, ``Post-Approval Audit Inspections''; 7356.002A, ``Sterile Drug Process Inspections''; 7356.002B, ``Repackers and Relabelers'', 7356.002C, ``Radioactive drugs'' and 7356.002E, ``Compressed medical gases'' Corrected title of drug program 7356.002 ``Drug Manufacturing Inspections'' corrected CPGM list by removing previously withdrawn Device programs 7385.002 ``Ionizing Radiation Use Control Laboratory Support'', 7385.003 ``Federal Facility Use Control and Equipment Performance Survey Program'', and 7386.006G ``WEAC Testing of Medical Devices for Conformance to Voluntary Standards'' corrected Device program numbers 7382.014 to 7385.014 and 7385.004 to 7386.009. New CPG Sec. 110.310--``Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002'' is available at: : cfsan.fda.gov ~pn cpgpn . Revised Debarment List, 10 22 2003--One person added. Published 10 23 03. Revised list to add 2 new members, 10 17 2003: Disqualified Totally Restricted List for Clinical Investigators. Published 10 21 03. Revised Debarment List, 10 2003--debarment terminated for one person; three people added. Published 10 03. Added pdf version of Guideline for the Monitoring of Clinical Investigations, Jan., 1988. Published 9 30 03. Revised list to add 2 new members, 09 2003: Restricted List for Clinical Investigators. Published 09 10 03. Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990, Updated 08 11 2003. Published 09 04 03. Revised Debarment List, 8 2003--one person added. Published 8 15 03. Revised Sec. 608.400--Compounding of Drugs for Use in Animals. Published 7 14 03. Revised 3 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990, Updated 01 27 3. Published 7 2 03. New CPGM link to Compliance Programs published by CBER: Inspection of Source Plasma Establishments and Inspections of Licensed Vaccines. Published 6 03. Updated ORA page on Electronic Records Signatures, 21 CFR Part 11. Published 6 03. Revised Debarment List, 5 9 2003--one person added. Published 5 30 03. Revoked effective 02 19 2003: Compliance Policy Guide, Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures CPG 7153.17 ; . See: 68 FR 8775 02 25 Published 5 30 03. Revised list to update Dr. J.L. Williams, 5 15 2003: Disqualified Totally Restricted List for Clinical Investigators. Published 5 23 03. Replaced Reference: Good Laboratory Practice GLP ; Final Rule, 12 22 1978. Published 5 23 03. Revised--Four Lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990, Updated 03 06 2003. Published 5 1 03. Revised Application Integrity Policy List to remove Gliatech, Inc., Beachwood, OH; and Solvay Pharmaceuticals, Inc., Beaudette, MN, and Marietta, GA, April 2003. Revised list to add new member, 04 10 2003: Disqualified Totally Restricted List for Clinical Investigators. Revised Debarment List on 04 09 2003--One person removed Hernandez, Delfina One correction inserted Lai, Elaine ; . Revised: Application Integrity Policy Committee Contact Persons list. Updated 3 31 2003. Revised 03 23 2003, HTml online links changed for Biologics Compliance Programs 7342.006, 7342.008. and 7345.001 CBER ; . No content was changed. New CPGM, 03 19 2003: Biologics Compliance Program March 2003, 7341.002, Inspection of Tissue Establishments CBER ; . Revoked effective 02 19 2003--Compliance Policy Guide, Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures CPG 7153.17 ; See: 68 FR 8775 02 25 Revised list to add new member, 02 10 2003: Disqualified Totally Restricted List for Clinical Investigators. Revised Debarment List on 01 13 2003--2 people added. 2002 Revisions and Updates Revised list to add new member, 10 28 2002: Disqualified Totally Restricted List for Clinical Investigators. Edited lists 12 16 2002: ; Inactive Labs List and 2 ; Active Tox Labs List Revised Debarment List on 12 03 2002--one person added Typographical errors 1 per page ; 11 27 2002: CPGuides Manual--Sec 555.425--Foods--Adulteration Involving Hard or Sharp Foreign Objects; and Sec. 515.350 Candy--Mixed with Trinkets and Sold in Vending Machines CPG 7105.04 ; Edited links 11 27 2002: CFR Part 11 Guidance Documents Dockets Established--Topics for Guidance Development Revised 11 14 2002: Sec. 555.600 Filth * from Insects, Rodents, and Other Pests * in Foods CPG 7120.18 ; Updated 11 14 2002: lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990 Revoked effective 11 12 2002: Sec. 398.475 Minimum X-Ray Field Size for Spot-Film Operation of Fluoroscopic Systems with Fixed SID and Without Stepless Adjustment of the Field Size CPG 7133.17 ; Revised 11 13 2002 Debarment List--3 people added Revised 2 lists to add new or update member s ; , 10 16 2002: Disqualified Totally Restricted List for Clinical Investigators and Restricted List for Clinical Investigators Revoked effective 10 07 2002, Sec. 300.700 Direct Reference Authority for Class III Medical Devices Without a Premarket Notification 510 k or an Approved Premarket Approval Application PMA ; CPG 7124.30 ; per Federal Register, 09 05 2002 FR 56850 ; Revised Subchapter Import for Export in Chapter 9 of Regulatory Procedures Manual. 09 13 2002. New--CryoLife, Inc., Kennesaw, GA, 08 13 2002. Order for Retention, Recall, and or Destruction New--Four Lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990. Updated 08 2002 Revised list to add new member, 08 7 2002: Disqualified Totally Restricted List for Clinical Investigators Revoked effective on 08 07 2002: Sec. 315.200 Status of Dental Supplies such as Denture Cleaners, Adhesives, Cushions, and Repair Materials as a Device or Cosmetic CPG 7124.05 ; See 67 FR 45129, 07 08 Revised list to add new member, 06 27 2002: Restricted List for Clinical Investigators Revised list to add new member, 06 27 2002: Disqualified Totally Restricted List for Clinical Investigators Reissued 05 29 2002, Sec. 460.200 Pharmacy Compounding Revoked effective on 06 20 2002, Sec. 391.100 Advertisement Literature for High-Intensity Mercury Vapor Discharge Lamps CPG 7133.13 ; Revoked effective on 06 20 2002, Sec. 396.100 Applicability of the Sunlamp Performance Standard To UVA Tanning Products CPG 7133.16 ; Corrected 05 16 2002, Sec 575.100 Pesticide Residues.Heptachlor table New CPG Sec. 230.150 Blood Donor Classification Statement, Paid or Volunteer Donor issued 05 07 2002 Revised BioResearch Monitoring Information references added or updated 05 16 2002 Revised Debarment List on 05 07 2002--person added Revised Compliance Program Manual 04 26 2002 page--page text and links were updated Edited Debarment List on 04 09 2002.
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