sure to go unless it pushes its plunger out.
A pharmaceutical autoclave is also known as an overpressure steril-
izer. Overpressure sterilization is a precisely controlled process ideal
for terminal sterilization of soft packaged items, especially sealed liq-
uids. I'd say only about 10% of compounding pharmacies have one.
2. Have you done stability studies?
In essence, you're asking how confident the pharmacy is in the expira-
tion date of its products. A drug can't pass below 90% of its potency
before its expiration date. When you do stability studies, you have to
make sure nothing untoward or unexpected shows up in drugs. Some
degraded drugs can be up to 90% potent, but can be toxic or harmful.
The answer you're looking for: "We've done the stability study and we
know what the extractable profile is and what the degradation profile
is so that we can be confident in the expiration date we're putting on
the product."
3. Are you compliant with USP <797>?
USP <797> helps to ensure patients receive quality preparations that
are free from contaminants and are consistent in intended identity,
strength and potency. It describes a number of requirements, includ-
ing responsibilities of compounding personnel, training, environmen-
tal monitoring, storage and testing of finished preparations. You want
to hear things like, "Yes, I have my equipment in a separate room.
Instead of using laminar flow hoods, we use a barrier isolator. Our
operators are well trained. We remove all cardboard packaging."
4. Are you a registered 503B facility?
There are 2 types of compounding pharmacies: 503A and 503B.
503As are the classic practice of pharmacy where a doc writes a
prescription for a patient and the pharmacist compounds to that
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