Monday, October 12, 2009

expiration date for compounding drugs?

i need to know what is the correct expiration date for compounding drugs in hospital pharmacy..please give me the referenece or link also.
Answer:
In the labeling of every medication is an expiration based on the solvent or base the medicine is mixed in. I work in a hospital and do a good amount of compounding, everytime a new agent is added to the formulary we use the industry data to establish its expiration in D5W and NSS (for IV meds). If you have a specific drug question regarding expiration you should contact the drug's manufacturer via thier drug information line. This is the most definitive source for stability data as this is thier most important quality assurance test.
Expiration dates on drugs compounded in a pharmacy, hospital or the drug manufacturing plant all depend upon the stability factors of the specific chemicals added. The one that would expire first is the basis for the expiration date. The two previous answers are well written and well addressed. The correct answer MUST be a combination of the two PLUS this one. You should check with the current recipes in the files at the hospital compounding area to seek if a pre-established expiration date is given or to be used. If not check with a 'supervising pharmacist' and if you are a pharmacist check with the package insert, reference materials or the manufacture. A rule of thumb in retail pharmacy is to subtract a specific predetermined amount of time from the ingredient that will expire first in making a cream or an ointment or oral suspension (or the like). But still one must know the expiration dates of each ingredient. And yet there may be a specific procedure to calculate the expiration date for a given product.
In making IV's there is usually a 'cheat sheet' hung in the hospital pharmacy for you to use. This cheat sheet was probably prepared by a pharmacist. Once again if it is not listed on the cheat sheet, check with a pharmacist or contact the manufacture IF a package insert or other reference materials can not guide you to this information. Respectfully,
Jeanetta M CPhT BS Chem
Pharm Tech Educator
Founder/Owner of JeanettasPTCBStudyGroup
It's FREE!
there is no one place for stability data on compounded drugs. Therein lies the rub with compounded medications.Where I've worked there is always a reference listed to support the stability data.

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