General Chapter <795> Pharmaceutical Compounding—Nonsterile Preparations. In: United States Pharmacopeia and National Formulary (USP 43-NF 38). Revised January 1, 2014. Rockville, MD: The United States Pharmacopeia Convention Inc; 2020.
Proposed Revisions to <795> Pharmaceutical Compounding – Nonsterile Preparations. The United States Pharmacopeia Convention Inc; 2021. Available at: https://go.usp.org/l/323321/2021-08-31/5kmcjf/323321/1630438802OI493yjz/BUD_Scientific_Rationale_for_the_2021_Proposed_Revisions_to__795_.docx. Accessed November 15, 2021.
Pancorbo SA, Campagna KD, Devenport JK, et al.Task force report of competency statements for pharmacy practice. Am J Pharm Educ. 1987; 51:196–206.
Allen LV Jr. Establishing and marketing your extemporaneous compounding service. US Pharm. 1990; 15(Dec):74–7.
Remington's pharmaceutical sciences. 18th ed. Gennaro AR, ed. Easton, PA: Mack Publishing; 1990; 1630–1, 1658, 1660.
The United States Pharmacopeia, 22nd rev., and The National Formulary, 17th ed. Rockville, MD: The United States Pharmacopeial Convention; 1989.
USP DI Volume III: Approved drug products and legal requirements. 14th ed. Rockville, MD: The United States Pharmacopeial Convention; 1994.
USP DI Volume I: Drug information for the health care professional. 14th ed. Rockville, MD: The United States Pharmacopeial Convention; 1994.
29 §C.F.R. 1910. 1200(1990).
ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm. 1990; 47:1033–49.
Feinberg JL. Complying with OSHA's Hazard Communication Standard. Consult Pharm. 1991; 6:444, 446, 448.
Myers CE. Applicability of OSHA Hazard Communication Standard to drug products. Am J Hosp Pharm. 1990; 47:1960–1.
21 C.F.R. §211.137.
Connors KA, Amidon GL, Stella VJ. Chemical stability of pharmaceuticals: a handbook for pharmacists. 2nd ed. New York: Wiley; 1986.
American Society of Hospital Pharmacists. ASHP guidelines on preventing medication errors in hospitals. Am J Hosp Pharm. 1993; 50:305–14.
Fitzgerald WL Jr. The legal authority to compound in pharmacy practice. Tenn Pharm. 1990; 26(Mar):21–2.
Associated Press. Pittsburgh woman loses eye to tainted drugs; 12 hurt. Baltimore Sun. 1990; Nov 9:3A.
Associated Press. Eye drop injuries prompt an FDA warning. N Y Times. 1990; 140(Dec 9):39I.
Jeglum EL, Rosenberg SB, Benson WE. Preparation of intravitreal drug doses. Ophthalmic Surg. 1981; 12:355–9.
Reynolds LA. Guidelines for preparation of sterile ophthalmic products. Am J Hosp Pharm. 1991; 48:2438–9.
Reynolds LA, Closson R. Ophthalmic drug formulations. A handbook of extemporaneous products. Vancouver, WA: Applied Therapeutics; 1993.
The United States Pharmacopeia, 22nd rev., and The National Formulary, 17th ed. Rockville, MD: The United States Pharmacopeial Convention; 1989:1692–3.
Allen LV. Indomethacin 1% ophthalmic suspension. US Pharm. 1991; 16(May):82–3.
American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm. 1990; 47:1033–49.
OSHA work-practice guidelines for personnel dealing with cytotoxic (antineoplastic) drugs. Am J Hosp Pharm. 1986; 43:1193–204.
Ansel HC, Popovich NG. Pharmaceutical dosage forms and drug delivery systems. 5th ed. Philadelphia: Lea & Febiger; 1990:354–7.
Stolar MH. Expiration dates of repackaged drug products. Am J Hosp Pharm. 1979; 36:170. Editorial.
Remington's pharmaceutical sciences. 19th ed. Gennaro AR, ed. Easton, PA: Mack Publishing; 1990:1581–959.
ASHP. Compounded Oral Liquid Version 1.01. https://www.ashp.org/-/media/assets/pharmacy-practice/s4s/docs/s4s-ashp-oral-compound-liquids.ashx?la=en&hash=0D7770B13939378D2F300E988F85F4205694FBB9. Published July 2017. Accessed July 1, 2020.
Containment ventilated enclosure (CVE) or biological safety cabinet (BSC), graduated cylinder, beaker, magnetic stirrer, filter
Caution: Hazardous Drug—Antineoplastic drug: Must be prepared in compliance with USP <800>.
Open capsules and empty contents into a beaker.
Add sterile water for irrigation in increasing amounts while mixing thoroughly.
Vigorously stir for several hours using a magnetic stirrer.
Filter solution to remove insoluble excipients.
Transfer contents of the beaker to a graduated cylinder.
Rinse the beaker with vehicle and pour into graduated cylinder.
Add vehicle to the graduated cylinder to achieve the total volume indicated above.
Transfer contents of the graduated cylinder into an appropriately sized amber bottle.
Shake well to mix.
Quality-Control Procedures — Visually inspect for physical appearance of formulation and container closure integrity (no leakage, cracks in container, or improper seals).
Labeling Requirements — Extemporaneously compounded preparation. Caution: antineoplastic drug. For oral use only. Store at room temperature. Shake well before use.
Storage Conditions/Stability — Store at room temperature. Stable for 180 days.
Study Container Type — Amber plastic bottle
Referenced Manufacturers — Hydroxyurea capsules (Hydrea, Bristol-Myers Squibb); Syrpalta, dye-free (Humco); sterile water for irrigation (not specified).
Stability-Indicating Study — No
Heeney MM, Whorton MR, Howard TA, et al.Chemical and functional analysis of hydroxyurea oral solutions. J Pediatr Hematol Oncol. 2004;26:179–184.
© 2022 American Society of Health-System Pharmacists. All Right Reserved.
Powered by: PubFactory
Character limit 500/500