Compounding Missed Questions

A pharmacist is required to re-check, or perform a second check on a compounded sterile product if the product

I. Was stocked into a Pyxis machine of a hospital for at least 24 hours before being dispensed to the patient

II. Has been dispensed to a patient’s bedside of a hospital, but is not actually used for 24 hours from time of dispensing

III. Has been dispensed in a retail pharmacy, but then awaits pick-up by the patient in duration greater than 24 hours

None of the above

• Placing a compounded sterile preparation (CSP) in an automated dispensing cabinet (like Pyxis) for floor stock is not limited to a 24-hour supply by <797>; releasing it to the floor is considered similar to dispensing to a patient, so no additional pharmacist second check is needed. Nurses should still visually check all sterile drugs prior to administration.

• Once a CSP has been verified and released/dispensed by a pharmacist (e.g., placed for patient pickup or delivery), no repeat pharmacist check is required before the CSP goes to the patient. The required visual inspection is done at the time of release or dispensing.

You have just been hired to an independent pharmacy that prepares compounded drug products. Which of the following products are required to be prepared as sterile? Select all that apply.

• A - Ophthalmic products

• B - Aqueous inhalation solutions/suspensions

• C - Otic products

• D - Nasal sprays

• E - Irrigations for the mouth

A and B

• Sterile compounding (CSP) is required if the preparation:

  • Is intended for delivery to a body space that does not have direct contact with the external environment (e.g., bladder, peritoneal cavity).

  • Is an ophthalmic product (for the eye).

  • Is a compounded aqueous inhalation solution or suspension.

• Nonsterile compounding (CNSP) is usually appropriate for:

  • Otic (ear) products, unless they are for use in a perforated eardrum.

  • Irrigations intended for the mouth, rectal cavity, or sinus cavity.

  • Nasal sprays.

Which of the following is required to be worn by the compounder when performing non-sterile compounding in a pharmacy?

I. Gloves
II. Head/hair covers
III. Gowns

I only

Only gloves are required for all compounding activities. Other garb should be worn as required by the facility’s standard operating procedures.

Which of the following should be included in the Compounding Record for prepration of a non-sterile product? Select all that apply.

• A - Lot number of the product(s) used

• B - Mixing instructions

• C - Expiration dates of the product(s) used

• D - Name of person who prepared the product

• E - Documentation of any issues reported by the patient

A, C, D, E

Outsourcing facilities differ in compounding regulations from that of community pharmacies. Outsourcing facilities (Select all that apply)

• A - May obtain prescriptions to compound drug products for individual patients

• B - May compound drug products in large batches, NOT for individual patients

• C - Are subject to Current Good Manufacturing Practice (CGMP) regulations

• D - May compound drug products for health care practitioners to have on-hand

A, B, C, D

• Section 503A (Traditional Compounding Pharmacies and Physicians):

  • Requires a prescription for an identified individual patient (or a very limited amount in advance, based on a pattern of prescription orders).

  • Compounded drugs must be made by a licensed pharmacist in a state-licensed pharmacy or federal facility, or by a licensed physician.

  • Compounding for “office use” (i.e., without a specific patient prescription) is generally not permitted under federal law, though there is some variation by state.

• Section 503B (Outsourcing Facilities):

  • May or may not obtain prescriptions for identified individual patients.

  • Can compound medications to be supplied to health care practitioners for office use, so drug products are available when not specifically compounded for a named patient.

  • Must comply with FDA current good manufacturing practice (CGMP) requirements and register with the FDA.

In general, pharmacies are prohibited from compounding products that are commercially available or is essentially a copy of a commercially available product. However, a pharmacy may compound a product that is essentially a copy if the prescriber indicates that this prescription (Select all that apply)

• A - Would produce a “significant difference” in the patient’s care compared to the commercial product

• B - Would produce a “significant difference” in price or cost to the patient compared to the commercial product

• C - Is necessary because the dosage form is different than that of the commercially available product

• D - Is necessary because the patient has an allergy to a component in the commercially available product

• E - Is necessary because the strength is different than that of the commercially available product

A, C, D, E

• The prescription must clearly state that the prescriber identified a specific change and the significant difference it will produce for the patient, not just the formulation or patient name.

• Acceptable notations include details like:

  • “No Dye X, patient allergy” (if standard product contains that dye)

  • “Liquid form, patient can’t swallow tablet” (if standard product is a tablet)

  • “6mg, patient needs higher dose” (if only a 5mg form is available)

• Vague instructions (e.g., only the patient name and the formulation) do not suffice—the prescriber's determination must be specific to the patient’s need.

• “Significant difference” must result from the formulation change, not from other factors like lower cost.

• Both 503A (traditional) and 503B (outsourcing) facilities are restricted from compounding drugs that are "essentially copies" of commercially available (or approved) drugs.

• If the original prescription is unclear, the compounder can consult the prescriber and, if confirmed, make a detailed note—including the date—about the specific need and change on the prescription.

Pharmacists that prepare or supervise compounding must ensure that water-containing sterile products that are non-sterile during any phase of the compounding process are sterilized within

A - 1 hour to minimize generation of bacterial endotoxins

B - 2 hours to minimize generation of bacterial endotoxins

C - 3 hours to minimize generation of bacterial endotoxins

D - 6 hours to minimize generation of bacterial endotoxins

D - 6 hours to minimize generation of bacterial endotoxins