Stability of flucytosine 50 mg/mL in extemporaneous oral liquid formulations.
VandenBussche HL, Johnson CE, Yun J, et al. Am J Health Syst Pharm 2002;59: 1853-1855.
The stability of a flucytosine 50-mg/mL oral liquid, prepared from the contents of flucytosine capsules mixed with equal volumes of Ora-Plus and either Ora-Sweet SF or strawberry syrup, is described. At least 99% of the initial flucytosine concentration was retained in both suspensions for 90 days, and this did not vary when stored at 23 deg C to 25 deg C or 3 deg C to 5 deg C. A procedure for compounding the flucytosine 50-mg/mL oral liquid is provided.
Compounding: The practice of pharmacy or a liability risk?
Spies AR.
Drug Top 2002;146(Jul 15):36-45. (ACPE approved for 2 hours of CE credit; available online from the Drug Topics website: www.drugtopics.com).
The author discusses current regulations regarding the compounding of drugs for human and animal use. Also, the author briefly highlights the legislative history related to compounding in humans following the US Food, Drug & Cosmetic Act in 1938 until the adoption of the Food & Drug Administration (FDA) Modernization Act in 1997. Based on the cases of Thompson v. Western Medical Centers and beans v. Caraway,2 guidelines to assist pharmacists in compounding prescription and over-the-counter drugs for humans are presented by the author. Using the FDA Compliance Policy Guide for Compounding of Drugs for Use in Animals3 as a reference, Spies provides three useful figures that deal with the necessary requirements for compounding a new animal drug, the labeling requirements for medications compounded for veterinary use, and situations involving veterinary compounding that are likely to be subject to regulatory action. The author points out that although the current laws and regulations allow pharmacists to compound, those compounding pharmacists who overstep the provisions of these acts may be faced with civil and criminal sanctions.
Not discussed in this article is the FDA's compounding guidance4 posted on the Internet in May 2002. The guidance describes nine potential actions that suggest that a pharmacy has gone beyond the limits of legitimate compounding for humans. Comments concerning this guidance are encouraged.
References
1. Thompson v. Western States Medical Center, 122 S.Ct. 1497, 152 L.Ed.2d 563, 2002 U.S. LEXIS 3035; 70 U.S.L.W. 4275 (2002).
2. Jeans v. Caraway, 649 So.2d 1141; 1995 La.App.LEXIS 179 (La. App. 3d Cir. 1995).
3. Sec.608.400 Compounding of Drugs for Use in Animals (CPG 7125.40). July 3,1996, Federal Register Doc. 96-16973. Available at: http://www.fda.gov/ora/compliance-ref/cpg/ cpgvet/cpg608-400.html. Accessed: November 25, 2002.
4. Sec.460.2 Pharmacy Compounding (CPG 460.200). Issued March 16, 1992; reissued May 29, 2002. Available at: http://www.fda. gov/ora/compliance-ref/cpg/cpgdrg/ cpg460-200.html. Accessed: January 22, 2003.
Copyright International Journal of Pharmaceutical Compounding Mar/Apr 2003
Provided by ProQuest Information and Learning Company. All rights Reserved
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