Get Allergen Extract For Immunotherapy

Allergy vials should be kept refrigerated at all times. They may stay out in room temperature for about 6 hours.

An updated draft Chapter 797 provides standards unique to allergen extract compounding for individual patients. These standards include updated requirements for personnel qualifications and training; personnel hygiene and garbing; facilities; cleaning and disinfecting; and documentation and labeling.

What Is USP 797? USP 797 refers to chapter 797 "Pharmaceutical Compounding – Sterile Preparations," in the USP National Formulary. It is the first set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP).

Specifically, the chapter is designed to "prevent patient harm and fatality from microbial contamination (nonsterility), excessive bacterial endotoxins, large content errors in the strength of correct ingredients, and incorrect ingredients in CSPs." The Joint Commission actively enforces USP Chapter 797 compliance as ...

USP <797> explicitly states that the standards do apply to all places where CSPs are prepared, including physicians' practice facilities. Enforcement most likely falls under state agencies, such as state boards of pharmacy, state boards of medicine, and state departments of health.

Injectable allergen extracts are used for both diagnosis and treatment and are sterile liquids that are manufactured from natural substances (such as molds, pollens, insects, insect venoms, and animal hair) known to elicit allergic reactions in susceptible individuals.

Sterile therapeutic extracts are supplied in either Phenol Saline Diluent or in Diluent containing Glycerin 50% (v/v) for subcutaneous injection. Inactive ingredients may include: Sodium Chloride for isotonicity, Glycerin, and Sodium Bicarbonate as buffering agents.

Taking an antihistamine medication before getting your allergy shot can reduce the risk of a reaction, particularly a local reaction. Check with your doctor to see if this is recommended for you. The possibility of a severe reaction is scary — but you won't be on your own.