Designated person - ANSWER All facilities (pharmacies) must have this qualified & trained
person to be responsible for implementing appropriate compounding procedures.
Can be the same person for non-sterile, sterile, and hazardous compounding if a facility
performs all 3
Can be more than one person and it does not have to be a pharmacist
What is not included in compounding - ANSWER Mixing, reconstituting, or other acts
performed in accordance with directions contained in approved labeling or supplemental
materials provided by the product's manufacturer
Is adding flavor considered compounding? - ANSWER Yes, since it is outside of approved
labeling
What preparations are required to be sterile - ANSWER In general, preparations designed
to be delivered to a body part that does not have contact with the environment outside of
the body, such as the bladder cavity or peritoneal cavity
Ophthalmic products and compounded aqueous inhalation solutions and suspensions
What preparations are not required to be sterile - ANSWER Otic preparations, unless
being administered to a patient with a perforated eardrum
Irrigations for the mouth, rectal cavity, and sinus cavity
Nasal sprays
Is hazardous drug compounding sterile or non-sterile? - ANSWER Could be either
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, What products are pharmacies prohibited from compounding? - ANSWER Commercially
available or essentially a copy of a commercially available product
- May compound a very similar, but slightly different product that the prescriber prescribes if
it would produce a significant different in care and is necessary due to a change in dosage
form, strength, or omit component to which a patient has an allergy
Pharmacies should use components/substances in compliance with what - ANSWER USP
or National Formulary monograph if one exists for the substance
- If not, may use components from an FDA-approved drug
- If no such drug exists, use FDA list of bulk drug substances for use in compounding
Are compounding drugs prepared by pharmacies FDA approved? - ANSWER No, and
therefore not subject to CGMP requirements (Current Good Manufacturing Practices)
What materials call for the pharmacy to use special equipment dedicated specifically for that
one product or disposable equipment? - ANSWER Antibiotics, cytotoxic drugs, or
hazardous materials
Non-Sterile: How often do personnel who compound, or have direct oversight of
compounding, demonstrate knowledge and competency - ANSWER Initially and at least
every 12 months
Non-Sterile: Knowledge and competency training of compounding personnel - ANSWER
Understanding requirements of chapter 795, understand and interpret safety data sheets,
understand procedures related to compounding duties
Must be documented in the pharmacy
Re-evaluated annually
Non-Sterile: Gloves - ANSWER Required to be worn when compounding products
Change or wipe gloves before a new compounding
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person to be responsible for implementing appropriate compounding procedures.
Can be the same person for non-sterile, sterile, and hazardous compounding if a facility
performs all 3
Can be more than one person and it does not have to be a pharmacist
What is not included in compounding - ANSWER Mixing, reconstituting, or other acts
performed in accordance with directions contained in approved labeling or supplemental
materials provided by the product's manufacturer
Is adding flavor considered compounding? - ANSWER Yes, since it is outside of approved
labeling
What preparations are required to be sterile - ANSWER In general, preparations designed
to be delivered to a body part that does not have contact with the environment outside of
the body, such as the bladder cavity or peritoneal cavity
Ophthalmic products and compounded aqueous inhalation solutions and suspensions
What preparations are not required to be sterile - ANSWER Otic preparations, unless
being administered to a patient with a perforated eardrum
Irrigations for the mouth, rectal cavity, and sinus cavity
Nasal sprays
Is hazardous drug compounding sterile or non-sterile? - ANSWER Could be either
1
, What products are pharmacies prohibited from compounding? - ANSWER Commercially
available or essentially a copy of a commercially available product
- May compound a very similar, but slightly different product that the prescriber prescribes if
it would produce a significant different in care and is necessary due to a change in dosage
form, strength, or omit component to which a patient has an allergy
Pharmacies should use components/substances in compliance with what - ANSWER USP
or National Formulary monograph if one exists for the substance
- If not, may use components from an FDA-approved drug
- If no such drug exists, use FDA list of bulk drug substances for use in compounding
Are compounding drugs prepared by pharmacies FDA approved? - ANSWER No, and
therefore not subject to CGMP requirements (Current Good Manufacturing Practices)
What materials call for the pharmacy to use special equipment dedicated specifically for that
one product or disposable equipment? - ANSWER Antibiotics, cytotoxic drugs, or
hazardous materials
Non-Sterile: How often do personnel who compound, or have direct oversight of
compounding, demonstrate knowledge and competency - ANSWER Initially and at least
every 12 months
Non-Sterile: Knowledge and competency training of compounding personnel - ANSWER
Understanding requirements of chapter 795, understand and interpret safety data sheets,
understand procedures related to compounding duties
Must be documented in the pharmacy
Re-evaluated annually
Non-Sterile: Gloves - ANSWER Required to be worn when compounding products
Change or wipe gloves before a new compounding
2
