If you or your friends are a drug manufacturer and want to sell your products in any of the Regulated markets then whether you know that you cannot sell the product without approval?
If you will do that then it will be non-compliance with respect to many Regulations.
If these products are unapproved new drugs introduced into interstate commerce then they will be in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 355(a)].
Furthermore, these products are misbranded drugs under section 502 of the FD&C Act [21 U.S.C. § 352].
The introduction or delivery for introduction of these products into interstate commerce is prohibited under sections 301(a), 301(d), and 301(k) of the FD&C Act [21 U.S.C. § 331(a), 331(d), and 331(k)].
We worked in the companies which are aware of this fact, we have come in contact with the companies which are also working accordingly that they get approval and then sell the product in the US market.
But the case study which I have read today is about the company that kept the new drug product on sale on their website without having approval. And hence become part of non-compliance.
If you come across any such company, pls make them aware of this fact.
The drugs of this company are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body.
These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses.
With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)].
No approved applications pursuant to section 505 of the FD&C Act are in effect for these products.
Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.
So the company got WL.
What do you conclude?
Make your friends aware of this if they are making mistakes. Many times people start a business in Pharma Manufacturing as they have enough funds but they do not have an idea about the Regulations.
By the way, keep reading my book " Blue Ocean of Compliance".
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And you will not be the same person before doing all this.