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.
Place tablets in an appropriately sized amber bottle.
Add purified water USP to amber bottle and allow to stand for a minimum of 5 minutes.
Shake the container for at least 1 minute and allow the suspension to stand for at least 1 minute.
Repeat shaking/standing process four additional times.
Add Ora-Plus and Ora-Sweet to the container and shake for at least 1 minute.
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. For oral use only. Store in refrigerator. Shake well before use.
Storage Conditions/Stability — Refrigerate. Stable for 28 days.
Study Container Type — Amber polyethylene terephthalate (PET) bottle
Referenced Manufacturers — Olmesartan medoxomil tablets (Benicar, Daiichi Sankyo, Inc); purified water USP (not specified); Ora-Plus, Ora-Sweet (Paddock Laboratories, LLC).
Stability-Indicating Study — No
Benicar [prescribing information]. Basking Ridge, NJ: Daiichi Sankyo, Inc; 2019.
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