ewmon Posted November 7, 2012 Posted November 7, 2012 I figured that the Lounge is as good a place as any to post this thread. Having a biopharmaceutical lab career, I recently had interesting talks with a friend who works in a doctor's office, specifically a gynecologist's office. In biopharma labs, we must properly label and store all substances. The label must show the substance's name, its lot number, its concentration, its expiration date and its storage requirements. In my friend's office, liquid substances are decanted into simple jars and cups with simple labels that give only the name of the substance (such as "Ferric sulfate" and "Lugols") — without any lot number, concentration, expiration date or storage requirements — and these containers are often left uncovered and unattended for days on end, including overnight. If we did this in biopharma labs, the FDA would come down on us like a ton of bricks even though our substances aren't used on people (or animals). In the doctor's office, these substances are administered to real people, most likely topically, and the doctors and nurses are apparently unaware of their lot numbers, expiration dates and storage requirements. Their concentrations are anyone's guess, depending on whether the solutes or the solvents evaporate more readily. My question is, do doctor's offices have similar requirements (lot numbers, concentration, expiration date and storage requirements) for substances for the safety of their patients? Additionally, when biopharma labs use software to perform computations, the software must be certified. However my friend's office is littered with various pregnancy slide rules produced by what seems to be every maker of gynecological product. Again, if biopharma lab techs using something so unofficial and gimmicky for computations, it would likewise result in a ton-of-bricks response from the FDA. Are such practices common in doctors' offices?
John Cuthber Posted November 8, 2012 Posted November 8, 2012 Part of the explanation is that the doctor could only harm a rather limited number of people but a pharma company could harm many. Also, you seem not to take account of the doctor's knowledge and experience.
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