-
1
-
-
84876222992
-
Federal and State Role in Pharmacy Compounding and Reconstitution: Exploring the Right Mix to Protect Patients
-
108th Cong Accessed Sept 2012
-
Galson SK. Federal and State Role in Pharmacy Compounding and Reconstitution: Exploring the Right Mix to Protect Patients. Hearing on Oversight Before the Senate Comm. on Health, Education, Labor, & Pensions, 108th Cong. 2003. http://www.fda.gov/NewsEvents/Testimony/ucm115010.htm. Accessed Sept 2012.
-
(2003)
Hearing on Oversight before the Senate Comm. on Health, Education, Labor, & Pensions
-
-
Galson, S.K.1
-
2
-
-
84865045237
-
-
United States Food and Drug Administration Accessed Sept 2012
-
United States Food and Drug Administration. The special risks of pharmacy compounding. 2012. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107836. htm. Accessed Sept 2012.
-
(2012)
The Special Risks of Pharmacy Compounding
-
-
-
3
-
-
84867729655
-
Pharmacy compounding primer for physicians: Prescriber beware
-
23039281 10.2165/11640850-000000000-00000
-
Sellers S, Utian WH. Pharmacy compounding primer for physicians: prescriber beware. Drugs. 2012;72(16):2043-50.
-
(2012)
Drugs
, vol.72
, Issue.16
, pp. 2043-2050
-
-
Sellers, S.1
Utian, W.H.2
-
5
-
-
84869781222
-
Fungal meningitis from injection of contaminated steroids: A compounding problem
-
23104261 1:CAS:528:DC%2BC3sXkt1Chsg%3D%3D
-
Wilson LE, Blythe D, Sharfstein JM. Fungal meningitis from injection of contaminated steroids: a compounding problem. JAMA. 2012;308(23):2461-2.
-
(2012)
JAMA
, vol.308
, Issue.23
, pp. 2461-2462
-
-
Wilson, L.E.1
Blythe, D.2
Sharfstein, J.M.3
-
7
-
-
84876251398
-
-
National Association of Boards of Pharmacy Accessed Jan 2013
-
National Association of Boards of Pharmacy. Model Pharmacy Act/Rules. 2012. http://www.nabp.net/government-affairs/model-pharmacy-act-rules. Accessed Jan 2013.
-
(2012)
Model Pharmacy Act/Rules
-
-
-
8
-
-
77953635458
-
Compounding problems and compounding confusion: Federal regulation of compounded drug products and the FDAMA circuit split
-
20481406
-
Boodoo JM. Compounding problems and compounding confusion: federal regulation of compounded drug products and the FDAMA circuit split. Am J Law Med. 2010;36(1):220-47.
-
(2010)
Am J Law Med
, vol.36
, Issue.1
, pp. 220-247
-
-
Boodoo, J.M.1
-
11
-
-
84876276713
-
-
Accessed July 2012
-
Draper R. The Toxic Pharmacist. 2003. http://www.nytimes.com/2003/06/08/ magazine/the-toxic-pharmacist.html?pagewanted=all&src=pm. Accessed July 2012.
-
(2003)
The Toxic Pharmacist
-
-
Draper, R.1
-
12
-
-
15244341908
-
Quality-control analytical methods: USP chapter 797 compounded sterile preparations sterility requirements and their relationship to beyond-use dating
-
Kastango E. Quality-control analytical methods: USP chapter 797 compounded sterile preparations sterility requirements and their relationship to beyond-use dating. Int J Pharm Compd. 2004;8(5):393-7.
-
(2004)
Int J Pharm Compd
, vol.8
, Issue.5
, pp. 393-397
-
-
Kastango, E.1
-
13
-
-
84876220051
-
-
United States Pharmacopeia 35 - National Formulary 30. Rockville: United States Pharmacopeial Convention
-
Pharmaceutical compounding - sterile preparations (general chapter 797). United States Pharmacopeia 35 - National Formulary 30. Rockville: United States Pharmacopeial Convention; 2012.
-
(2012)
Pharmaceutical Compounding - Sterile Preparations (General Chapter 797)
-
-
-
14
-
-
84876250615
-
-
United States Pharmacopeia 35 - National Formulary 30. Rockville: United States Pharmacopeial Convention
-
Sterility Tests (general chapter 71). United States Pharmacopeia 35 - National Formulary 30. Rockville: United States Pharmacopeial Convention; 2012.
-
(2012)
Sterility Tests (General Chapter 71)
-
-
-
15
-
-
84876251398
-
-
National Association of Boards of Pharmacy Accessed Apr 2012
-
National Association of Boards of Pharmacy Model Pharmacy Act/Rules Page 207. 2012. http://www.nabp.net/government-affairs/model-actrules/. Accessed Apr 2012.
-
(2012)
Model Pharmacy Act/Rules
, pp. 207
-
-
-
16
-
-
84876253100
-
-
February 9-10, 2010, Proposal of Rules, Rules Concerning Use of Sterile Gloves and Sterile Alcohol in Pharmacies Compounding Sterile Preparations (§291.133] Accessed Nov 2012
-
Texas State Board of Pharmacy, Business Meeting Minutes, February 9-10, 2010, Proposal of Rules, Rules Concerning Use of Sterile Gloves and Sterile Alcohol in Pharmacies Compounding Sterile Preparations (§291.133]. 2010. http://www.tsbp.state.tx.us/files-pdf/min2-2010.pdf. Accessed Nov 2012.
-
(2010)
Texas State Board of Pharmacy, Business Meeting Minutes
-
-
-
18
-
-
84876211103
-
-
Tainted TPN Cases Put Focus on Rules, June 2011 Accessed Nov 2012
-
Tainted TPN Cases Put Focus on 797 Rules, Pharmacy Practice News, June 2011, Volume 38. 2011. http://issuu.com/mcmahongroup/docs/ppn0611-de. Accessed Nov 2012.
-
(2011)
Pharmacy Practice News
, vol.38
-
-
-
19
-
-
84876208504
-
-
Institute for Safe Medical Practices Safety Alert. chapter Accessed July 2012
-
Institute for Safe Medical Practices Safety Alert. TPN-related deaths call for FDA guidance and pharmacy board oversight of USP chapter 797. 2011. http://www.ismp.org/newsletters/acutecare/articles/20110407.asp. Accessed July 2012.
-
(2011)
TPN-related Deaths Call for FDA Guidance and Pharmacy Board Oversight of USP
, vol.797
-
-
-
20
-
-
31544445795
-
Turning a new chapter on IV drug compounding safety: USP/NF chapter 797
-
Fricker MP, Trissel LA, Rich DS. Turning a new chapter on IV drug compounding safety: USP/NF chapter 797. Hosp Pharm. 2004;9:899-920.
-
(2004)
Hosp Pharm
, vol.9
, pp. 899-920
-
-
Fricker, M.P.1
Trissel, L.A.2
Rich, D.S.3
-
21
-
-
84864261004
-
-
ACOG Committee opinion no. 532: compounded bioidentical menopausal hormone therapy
-
ACOG Committee opinion no. 532: compounded bioidentical menopausal hormone therapy. Obstet Gynecol. 2012;120(2 Pt 1):411-5.
-
(2012)
Obstet Gynecol
, vol.120
, Issue.2 PART 1
, pp. 411-415
-
-
-
22
-
-
13444262733
-
A primer on USP chapter 797 "pharmaceutical compounding - Sterile preparations", and USP process for drug and practice standards
-
Newton D, Trissel L. A primer on USP chapter 797 "pharmaceutical compounding - sterile preparations", and USP process for drug and practice standards. Int J Pharm Compd. 2004;8(4):251-63.
-
(2004)
Int J Pharm Compd
, vol.8
, Issue.4
, pp. 251-263
-
-
Newton, D.1
Trissel, L.2
-
23
-
-
84876215964
-
-
Health Canada: Health Products and Food Branch Inspectorate Accessed Jan 2013
-
Health Canada: Health Products and Food Branch Inspectorate. Policy on manufacturing and compounding drug products in Canada POL-0051. 2009. http://www.hc-sc.gc.ca/dhp-mps/alt-formats/hpfb-dgpsa/pdf/compli-conform/ pol-0051-eng.pdf. Accessed Jan 2013.
-
(2009)
Policy on Manufacturing and Compounding Drug Products in Canada POL-0051
-
-
-
24
-
-
77950438224
-
-
United States Food and Drug Administration Accessed Mar 2013
-
United States Food and Drug Administration. Limited FDA Survey of Compounded Drug Products. 2001. http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm155725.htm. Accessed Mar 2013.
-
(2001)
Limited FDA Survey of Compounded Drug Products
-
-
-
25
-
-
79960561264
-
-
US Food and Drug Administration. Pharmacy Compounding Accessed Sept 2012
-
US Food and Drug Administration. Pharmacy Compounding. 2006 Limited FDA Survey of Compounded Drug Products. 2012. http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm204237.htm. Accessed Sept 2012.
-
(2012)
2006 Limited FDA Survey of Compounded Drug Products
-
-
-
27
-
-
40349093183
-
Unknown risks of pharmacy-compounded drugs
-
18303067
-
Sasich LD, Sukkari SR. Unknown risks of pharmacy-compounded drugs. J Am Osteopath Assoc. 2008;108(2):86.
-
(2008)
J Am Osteopath Assoc
, vol.108
, Issue.2
, pp. 86
-
-
Sasich, L.D.1
Sukkari, S.R.2
-
28
-
-
84876231402
-
-
Texas State Board of Pharmacy, Business Meeting Minutes November 9, 2010 Tab 24 Accessed Nov 2012
-
Texas State Board of Pharmacy, Business Meeting Minutes, November 9, 2010, Report on TSBP Sampling of Compounded Products, Tab 24. 2010. http://www.tsbp.state.tx.us/files-pdf/BN/Nov10/Additions/Tab24- Compounded%20Sample%20Testing.pdf. Accessed Nov 2012.
-
(2010)
Report on TSBP Sampling of Compounded Products
-
-
-
29
-
-
34247855841
-
Quality of extemporaneously compounded nitroglycerin ointment
-
17476559 10.1007/s10350-006-0818-5
-
Azarnoff DL, Lee JC, Lee C, et al. Quality of extemporaneously compounded nitroglycerin ointment. Dis Colon Rectum. 2007;50(4):509-16.
-
(2007)
Dis Colon Rectum
, vol.50
, Issue.4
, pp. 509-516
-
-
Azarnoff, D.L.1
Lee, J.C.2
Lee, C.3
-
30
-
-
84856342198
-
Content variability of active drug substance in compounded oral 3,4-diaminopyridine products
-
21501202 10.1111/j.1365-2710.2011.01249.x 1:CAS:528:DC%2BC38XivFyjtr4%3D
-
Green DM, Jones AC, Brain KR. Content variability of active drug substance in compounded oral 3,4-diaminopyridine products. J Clin Pharm Ther. 2012;37(1):53-7.
-
(2012)
J Clin Pharm Ther
, vol.37
, Issue.1
, pp. 53-57
-
-
Green, D.M.1
Jones, A.C.2
Brain, K.R.3
-
31
-
-
11144227902
-
Sodium tetradecyl sulfate for sclerotherapy treatment of veins: Is compounding pharmacy solution safe?
-
discussion 1456
-
Goldman MP. Sodium tetradecyl sulfate for sclerotherapy treatment of veins: is compounding pharmacy solution safe? Dermatol Surg. 2004;30(12 Pt 1):1454-6; discussion 1456.
-
(2004)
Dermatol Surg
, vol.30
, Issue.12 PART 1
, pp. 1454-1456
-
-
Goldman, M.P.1
-
32
-
-
9644257166
-
Investigation of product quality between extemporaneously compounded progesterone vaginal suppositories and an approved progesterone vaginal gel
-
15595573 10.1081/DDC-200040251 1:CAS:528:DC%2BD2cXptlSrsLs%3D
-
Mahaguna V, McDermott JM, Zhang F, et al. Investigation of product quality between extemporaneously compounded progesterone vaginal suppositories and an approved progesterone vaginal gel. Drug Dev Ind Pharm. 2004;30(10):1069-78.
-
(2004)
Drug Dev Ind Pharm
, vol.30
, Issue.10
, pp. 1069-1078
-
-
Mahaguna, V.1
McDermott, J.M.2
Zhang, F.3
-
33
-
-
84859353705
-
Quality investigation of hydroxyprogesterone caproate active pharmaceutical ingredient and injection
-
22329865 10.3109/03639045.2012.662511 1:CAS:528:DC%2BC38Xks1Orsbk%3D
-
Chollet JL, Jozwiakowski MJ. Quality investigation of hydroxyprogesterone caproate active pharmaceutical ingredient and injection. Drug Dev Ind Pharm. 2012;38(5):540-9.
-
(2012)
Drug Dev Ind Pharm
, vol.38
, Issue.5
, pp. 540-549
-
-
Chollet, J.L.1
Jozwiakowski, M.J.2
-
35
-
-
84876213033
-
GAO testimony: Federal and State Role in Pharmacy Compounding and Reconstitution: Exploring the Right Mix to Protect Patients: Hearing on Oversight before the Senate Comm
-
Accessed Mar 2013
-
Heinrich J. GAO testimony: Federal and State Role in Pharmacy Compounding and Reconstitution: Exploring the Right Mix to Protect Patients: Hearing on Oversight Before the Senate Comm. on Health, Education, Labor, & Pensions, 108th Cong. 2003. http://gao.gov/assets/120/110456.pdf. Accessed Mar 2013.
-
(2003)
On Health, Education, Labor, & Pensions, 108th Cong
-
-
Heinrich, J.1
-
36
-
-
33748656492
-
Outbreak of Serratia marcescens infections following injection of betamethasone compounded at a community pharmacy
-
10.1086/507336
-
Civen R, Vugia DJ, Alexander R, et al. Outbreak of Serratia marcescens infections following injection of betamethasone compounded at a community pharmacy. Clin Infect Dis Off Publ Infect Dis Soc Am. 2006;43(7):831-7.
-
(2006)
Clin Infect Dis off Publ Infect Dis Soc Am
, vol.43
, Issue.7
, pp. 831-837
-
-
Civen, R.1
Vugia, D.J.2
Alexander, R.3
-
37
-
-
84875376105
-
Pediatric thioridazine poisoning as a result of a pharmacy compounding error
-
21589825 10.4081/pr.2009.e9
-
Kato Z, Nakamura M, Yamagishi Y, et al. Pediatric thioridazine poisoning as a result of a pharmacy compounding error. Pediatr Rep. 2009;1(1):e9.
-
(2009)
Pediatr Rep
, vol.1
, Issue.1
, pp. 9
-
-
Kato, Z.1
Nakamura, M.2
Yamagishi, Y.3
-
38
-
-
0034885684
-
A 1000-fold overdose of clonidine caused by a compounding error in a 5-year-old child with attention-deficit/hyperactivity disorder
-
11483818 10.1542/peds.108.2.471 1:STN:280:DC%2BD3MvjvVWltQ%3D%3D
-
Romano MJ, Dinh A. A 1000-fold overdose of clonidine caused by a compounding error in a 5-year-old child with attention-deficit/hyperactivity disorder. Pediatrics. 2001;108(2):471-2.
-
(2001)
Pediatrics
, vol.108
, Issue.2
, pp. 471-472
-
-
Romano, M.J.1
Dinh, A.2
-
39
-
-
66949148766
-
An outbreak of postoperative gram-negative bacterial endophthalmitis associated with contaminated trypan blue ophthalmic solution
-
10.1086/598938
-
Sunenshine R, Schultz M, Lawrence MG, et al. An outbreak of postoperative gram-negative bacterial endophthalmitis associated with contaminated trypan blue ophthalmic solution. Clin Infect Dis Off Publ Infect Dis Soc Am. 2009;48(11):1580-3.
-
(2009)
Clin Infect Dis off Publ Infect Dis Soc Am
, vol.48
, Issue.11
, pp. 1580-1583
-
-
Sunenshine, R.1
Schultz, M.2
Lawrence, M.G.3
-
40
-
-
0036678253
-
Pediatric clonidine poisoning as a result of pharmacy compounding error
-
12187137 10.1097/00006565-200208000-00014
-
Suchard JR, Graeme KA. Pediatric clonidine poisoning as a result of pharmacy compounding error. Pediatr Emerg Care. 2002;18(4):295-6.
-
(2002)
Pediatr Emerg Care
, vol.18
, Issue.4
, pp. 295-296
-
-
Suchard, J.R.1
Graeme, K.A.2
-
41
-
-
55849110038
-
Multistate outbreak of Pseudomonas fluorescens bloodstream infection after exposure to contaminated heparinized saline flush prepared by a compounding pharmacy
-
10.1086/592968
-
Gershman MD, Kennedy DJ, Noble-Wang J, et al. Multistate outbreak of Pseudomonas fluorescens bloodstream infection after exposure to contaminated heparinized saline flush prepared by a compounding pharmacy. Clin Infect Dis Off Publ Infect Dis Soc Am. 2008;47(11):1372-9.
-
(2008)
Clin Infect Dis off Publ Infect Dis Soc Am
, vol.47
, Issue.11
, pp. 1372-1379
-
-
Gershman, M.D.1
Kennedy, D.J.2
Noble-Wang, J.3
-
42
-
-
79960556159
-
Severe accidental overdose of 4-aminopyridine due to a compounding pharmacy error
-
19443164 10.1016/j.jemermed.2009.04.037
-
Schwam E. Severe accidental overdose of 4-aminopyridine due to a compounding pharmacy error. J Emerg Med. 2011;41(1):51-4.
-
(2011)
J Emerg Med
, vol.41
, Issue.1
, pp. 51-54
-
-
Schwam, E.1
-
43
-
-
36548999921
-
Compounded colistimethate as possible cause of fatal acute respiratory distress syndrome
-
18046039 10.1056/NEJMc071717 1:CAS:528:DC%2BD2sXhsVSlu7zF
-
McCoy KS. Compounded colistimethate as possible cause of fatal acute respiratory distress syndrome. N Engl J Med. 2007;357(22):2310-1.
-
(2007)
N Engl J Med
, vol.357
, Issue.22
, pp. 2310-2311
-
-
McCoy, K.S.1
-
44
-
-
33746855984
-
Life-threatening sepsis caused by Burkholderia cepacia from contaminated intravenous flush solutions prepared by a compounding pharmacy in another state
-
16785290 10.1542/peds.2005-2617
-
Held MR, Begier EM, Beardsley DS, et al. Life-threatening sepsis caused by Burkholderia cepacia from contaminated intravenous flush solutions prepared by a compounding pharmacy in another state. Pediatrics. 2006;118(1):e212-5.
-
(2006)
Pediatrics
, vol.118
, Issue.1
-
-
Held, M.R.1
Begier, E.M.2
Beardsley, D.S.3
-
46
-
-
0037074036
-
-
Exophiala infection from contaminated injectable steroids prepared by a compounding pharmacy - United States, July-November 2002
-
Exophiala infection from contaminated injectable steroids prepared by a compounding pharmacy - United States, July-November 2002. MMWR Morb Mortal Wkly Rep. 2002;51(49):1109-12.
-
(2002)
MMWR Morb Mortal Wkly Rep
, vol.51
, Issue.49
, pp. 1109-1112
-
-
-
47
-
-
35148828085
-
-
Deaths from intravenous colchicine resulting from a compounding pharmacy error - Oregon and Washington, 2007
-
Deaths from intravenous colchicine resulting from a compounding pharmacy error - Oregon and Washington, 2007. MMWR Morb Mortal Wkly Rep. 2007;56(40):1050-2.
-
(2007)
MMWR Morb Mortal Wkly Rep.
, vol.56
, Issue.40
, pp. 1050-1052
-
-
-
48
-
-
70449420084
-
Potential clinical impact of compounded versus noncompounded intrathecal baclofen
-
19887203 10.1016/j.apmr.2009.05.018
-
Moberg-Wolff E. Potential clinical impact of compounded versus noncompounded intrathecal baclofen. Arch Phys Med Rehabil. 2009;90(11):1815-20.
-
(2009)
Arch Phys Med Rehabil
, vol.90
, Issue.11
, pp. 1815-1820
-
-
Moberg-Wolff, E.1
-
52
-
-
84876226196
-
-
Food and Drug Administration Inspectional Observations (Form 483) New England Compounding Center issued October 26th, 2012 Accessed Nov 2012
-
Food and Drug Administration Inspectional Observations (Form 483) New England Compounding Center issued October 26th, 2012. 2012. http://www.fda.gov/ downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ ORA/ORAElectronicReadingRoom/UCM325980.pdf. Accessed Nov 2012.
-
(2012)
-
-
-
53
-
-
33750325021
-
The cost of quality in pharmacy
-
Kastango E. The cost of quality in pharmacy. Int J Pharm Compd. 2002;6(6):404-7.
-
(2002)
Int J Pharm Compd
, vol.6
, Issue.6
, pp. 404-407
-
-
Kastango, E.1
-
55
-
-
84865005940
-
Compounded sclerosing agents: Risks and consequences
-
Mckenna KJ. Compounded sclerosing agents: risks and consequences. Vein Mag. 2008;1(2).
-
(2008)
Vein Mag.
, vol.1
, Issue.2
-
-
McKenna, K.J.1
-
56
-
-
84865635252
-
Hydroxyprogesterone caproate injection (Makena) one year later: To compound or not to compound that is the question
-
22876106
-
Patel Y, Rumore MM. Hydroxyprogesterone caproate injection (Makena) one year later: to compound or not to compound that is the question. P T. 2012;37(7):405-11.
-
(2012)
P T.
, vol.37
, Issue.7
, pp. 405-411
-
-
Patel, Y.1
Rumore, M.M.2
|