[FRD]

How are the conditions of 21 CFR 206 (Imprinting of Solid Oral Dosage Form) met?

[Pharma Digests]

– It should be a unique identification of the drug product and the manufacturer or distributor of the product.
– It can be any single letter or number or any combination of letters and numbers.
– This is applicable for solid oral dosage form drug product.

• This reply was modified 8 months, 1 week ago by .

[FRD]

Is it mandatory for oral solid dosage drug product to use imprint code?

[Pharma Digests]

Yes, FDA requires for any solid dosage drug products of prescription or OTC be it tablets or capsules to have imprint code for product identification and to prevent fraud.

[FRD]

If the product is more sticky in nature, how to debossed on it?

[Pharma Digests]

@FRD
You can reduce the debossing/imprinting code or you can omit it with proper justification.

[Author]

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