Different Shapes Of Pills Fda Guidelines

Is there a reason for medications having different shapes, sizes and colors? If so when was the system first developed?

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Hello, Rclancy! How are you?

It isn't the shapes, sizes or colors that matter, that is entirely up to the whit and whim of the manufacturer. Some of them will use different colors or shapes to make it easier to distinguish one dose from another, but they do not have to do so.

The mandate under law by the FDA, is that all manufactured prescription medications must have unique markings on them to enable their identification, in case of emergency. For all the government cares, they could all be white, round tablets, as long as the markings on them are different, so they can be traced back to the original manufacturer, as well as allowing you to discover what the pills contain and the dosage.

As to the sizes, that can depend on the dosage and what inactive ingredients the manufacturer chooses to use. A higher dosage will usually require a pill to be bigger and some inactive binders and fillers are bulkier than others.

It is under Title 21 from 1993, though some form of a similar directive was around earlier than that and it does not apply to over the counter medications, only solid prescription forms.

An exception is also granted for speciality medications done by compounding pharmacies.

Is there anything else I can help with?

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