Compounding

Question 1

Chapter 795

Answer 1

regulations from USP/NF pertaining to the NON-sterile compounding of formulations

Question 2

Chapter 797

Answer 2

regulations from USP/NF pertaining to the sterile compounding of formulations

Question 3

1906 Pure Food and Drugs Act

Answer 3

Said USP responsible to set standards for compounding

Question 4

Documentation and record keeping

Answer 4

provides info that is directly applicable to the formulation being compounded

Question 5

Four sets of records must be kept in the compounding area

Answer 5

formulation record
compounding record
SOPs
ingredients record with certificates of purity and MSDSs

Question 6

Formulation record

Answer 6

consists of compounding formulas and procedures- a “recipe”

Question 7

Compounding record

Answer 7

what actually happened when the drug was compounded

Question 8

SOPs

Answer 8

SOP = standard operating procedures

equipment maintenance, calibration, handling and disposing supplies, etc

Question 9

Stability

Answer 9

the extent to which a dosage form retains, within specific limits, and throughout its period of storage as use, the same properties and characteristics that it possessed at the time of its manufacture

Question 10

assigning a beyond-use date

Answer 10

Follow these procedures:

1. follow in accordance with the manufacturer’s approved labeling
2. if not possible, use drug-specific and general stability documentation from reference books or primary literature
3. if not possible, refer to USP/NF Chapter 796

Question 11

beyond-use date

Answer 11

used for compounded preparations only

generally in the order of “days” or “months”

Question 12

expiration date

Answer 12

required on commercially manufactured products and are determined after extensive study of the product’s stability

most are in the order of “years”

Question 13

Compounding equipment types

Answer 13

measuring, mixing, molding, and packaging

Question 14

Class A prescription balances

Answer 14

determine weight of a powder

Question 15

Volumetric equipment

Answer 15

graduated cylinders, syringes, and pipets

NOT: erlenmeyer flasks, beakers, prescription bottles

Question 16

Trituration

Answer 16

fine grinding of powder

Reduces drug’s particle size.

Question 17

Levigation

Answer 17

trituration of a powder drug with a solvent in which the drug is insoluble.

Reduces drug’s particle size.

Question 18

Two major methods of compounding ointments

Answer 18

1. incorporating a drug into an ointment base

2. forming the base as part of the compounding process

Question 19

When preparing capsules, use ___ size of capsules first, since _______.

Answer 19

smallest

patients have a hard time swallowing larger capsules