• 1.

    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.

  • 1.

    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.

  • 1.

    Pancorbo SA, Campagna KD, Devenport JK, et al.Task force report of competency statements for pharmacy practice. Am J Pharm Educ. 1987; 51:196206.

    • Search Google Scholar
    • Export Citation
  • 2.

    Allen LV Jr. Establishing and marketing your extemporaneous compounding service. US Pharm. 1990; 15(Dec):747.

  • 3.

    Remington's pharmaceutical sciences. 18th ed. Gennaro AR, ed. Easton, PA: Mack Publishing; 1990; 16301, 1658, 1660.

  • 4.

    The United States Pharmacopeia, 22nd rev., and The National Formulary, 17th ed. Rockville, MD: The United States Pharmacopeial Convention; 1989.

    • Search Google Scholar
    • Export Citation
  • 5.

    USP DI Volume III: Approved drug products and legal requirements. 14th ed. Rockville, MD: The United States Pharmacopeial Convention; 1994.

    • Search Google Scholar
    • Export Citation
  • 6.

    USP DI Volume I: Drug information for the health care professional. 14th ed. Rockville, MD: The United States Pharmacopeial Convention; 1994.

    • Search Google Scholar
    • Export Citation
  • 7.

    29 §C.F.R. 1910. 1200(1990).

  • 8.

    ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm. 1990; 47:103349.

  • 9.

    Feinberg JL. Complying with OSHA's Hazard Communication Standard. Consult Pharm. 1991; 6:444, 446, 448.

  • 10.

    Myers CE. Applicability of OSHA Hazard Communication Standard to drug products. Am J Hosp Pharm. 1990; 47:19601.

  • 11.

    21 C.F.R. §211.137.

  • 12.

    Connors KA, Amidon GL, Stella VJ. Chemical stability of pharmaceuticals: a handbook for pharmacists. 2nd ed. New York: Wiley; 1986.

  • 13.

    American Society of Hospital Pharmacists. ASHP guidelines on preventing medication errors in hospitals. Am J Hosp Pharm. 1993; 50:30514.

    • Search Google Scholar
    • Export Citation
  • 14.

    Fitzgerald WL Jr. The legal authority to compound in pharmacy practice. Tenn Pharm. 1990; 26(Mar):212.

  • 1.

    Associated Press. Pittsburgh woman loses eye to tainted drugs; 12 hurt. Baltimore Sun. 1990; Nov 9:3A.

  • 2.

    Associated Press. Eye drop injuries prompt an FDA warning. N Y Times. 1990; 140(Dec 9):39I.

  • 3.

    Jeglum EL, Rosenberg SB, Benson WE. Preparation of intravitreal drug doses. Ophthalmic Surg. 1981; 12:3559.

  • 4.

    Reynolds LA. Guidelines for preparation of sterile ophthalmic products. Am J Hosp Pharm. 1991; 48:24389.

  • 5.

    Reynolds LA, Closson R. Ophthalmic drug formulations. A handbook of extemporaneous products. Vancouver, WA: Applied Therapeutics; 1993.

  • 6.

    The United States Pharmacopeia, 22nd rev., and The National Formulary, 17th ed. Rockville, MD: The United States Pharmacopeial Convention; 1989:16923.

  • 7.

    Allen LV. Indomethacin 1% ophthalmic suspension. US Pharm. 1991; 16(May):823.

  • 8.

    American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm. 1990; 47:103349.

    • Search Google Scholar
    • Export Citation
  • 9.

    OSHA work-practice guidelines for personnel dealing with cytotoxic (antineoplastic) drugs. Am J Hosp Pharm. 1986; 43:1193204.

  • 10.

    Ansel HC, Popovich NG. Pharmaceutical dosage forms and drug delivery systems. 5th ed. Philadelphia: Lea & Febiger; 1990:3547.

  • 11.

    Stolar MH. Expiration dates of repackaged drug products. Am J Hosp Pharm. 1979; 36:170. Editorial.

  • 12.

    Remington's pharmaceutical sciences. 19th ed. Gennaro AR, ed. Easton, PA: Mack Publishing; 1990:1581959.

Labetalol Hydrochloride Suspension 40 mg/mL—Formulation 1*

in Extemporaneous Formulations
Authors:
Rita K. Jew
,
Winson Soo-Hoo
,
Elham Amiri
, and
Jamie M. Gomes
Free access

INGREDIENTS:

Labetalol hydrochloride 300 mg tablet16 tablets
Ora-Plus/Ora-Sweet*QSAD: 120 mL

EQUIPMENT AND SUPPLIES:

Powder containment hood, mortar and pestle, graduated cylinder

PREPARATION DETAILS:

  1. Triturate tablets to a fine powder with a mortar and pestle.

  2. Levigate powder with a small amount of vehicle to form a paste.

  3. Add vehicle in increasing amounts while mixing thoroughly.

  4. Transfer contents of the mortar to a graduated cylinder.

  5. Rinse the mortar and pestle with vehicle and pour into graduated cylinder.

  6. Add vehicle to the graduated cylinder to achieve the total volume indicated above.

  7. Transfer contents of the graduated cylinder into an appropriately sized amber bottle.

  8. Shake well to mix.

Special Instructions — *Mix 60 mL of Ora-Plus with 60 mL of Ora-Sweet. Use mixture as vehicle or use Ora-Blend.

Alternatives — May substitute vehicle with cherry syrup (cherry syrup concentrate diluted 1:4 with simple syrup) or 60 mL of Ora-Plus mixed with 60 mL of Ora-Sweet SF or Ora-Blend SF.

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 at room temperature or refrigerate. Shake well before use.

Storage Conditions/Stability — Store at room temperature or refrigerate. Stable for 60 days.

STABILITY STUDY DETAILS:

Study Container Type — Amber clear plastic (polyethylene terephthalate [PET]) prescription oval with low-density polyethylene foam cap lining

Referenced Manufacturers — Labetalol hydrochloride tablets (Normodyne, Schering Corp); Ora-Plus, Ora-Sweet, Ora-Sweet SF (Paddock Laboratories, LLC); cherry syrup concentrate (Robinson Laboratories, Inc); simple syrup (not specified).

Stability-Indicating Study — Yes

REFERENCE

1.

Allen LV Jr, Erickson MA 3rd. Stability of labetalol hydrochloride, metoprolol tartrate, verapamil hydrochloride, and spironolactone with hydrochlorothiazide in extemporaneously compounded oral liquids. Am J Health Syst Pharm. 1996;53(19):23042309.

  • Crossref
  • Search Google Scholar
  • Export Citation