Ch 19 P 30 Compounding of Non-sterile Pharmaceuticals Flashcards
Active pharmaceutical ingredient (API)
Any substance or mixture of substances intended to be used in the compounding of a drug preparation, thereby becoming the active ingredient in that preparation and furnishing pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans and animals or affecting the structure and function of the body.
Beyond use date (BUD)
The date after which a compounded preparation should not be used and is determined from the date the preparation was compounded.
Component
Any ingredient intended for use in the compounding of a drug product, including those that may not appear in such product labeling.
Compounding
The preparation, mixing assembling, packaging, or labeling of a drug or device (reconstitution of commercial products is not considered compounding for purposes of this article).
(1) as the result of a practitioner’s prescription order, based on the practitioner-patient-pharmacist relationship in the course of professional practice;
(2) preparing limited quantities of prescription orders based upon a history of receiving valid prescriptions issued within an established practitioner-patient-pharmacist relationship in the course of professional practice;
(3) reconstitution of commercial products not considered compounding for purpose of this article.
FDA
Food and Drug administration
SOP’s
Standard operating procedures
USP/NF
The current edition of the United State Pharmacopeia/National Formulary
BUD for non-aqueous formulations
Not later than the time remaining until the earliest expiration date of any API or six months, whichever is earlier
BUD for water-containing oral formulations
Not later than 14 days when stored at a controlled cold temperature
BUD for water-containing topical/dermal and mucosal liquid and semisolid formulations
Not later than 30 days
