Regulatory Open Forum

​Good morning everyone,

Do you know of any requirements/regulations that state that Drug Substance Intermediate Manufacturers need to register their establishment with the FDA? The manufacturer is located outside of the US and we have recently received a question as part of a CRL asking for the manufacturer's FEI number. The establishment registration sections on FDA's website and in the CFR (207) are specific to drug substance/product; not intermediate.

Thanks,

Sabrina

@207.17   Who must register?

(a) Unless exempt under section 510(g) of the Federal Food, Drug, and Cosmetic Act or this part, all manufacturers, repackers, relabelers, and salvagers must register each domestic establishment that manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new animal drug, and each foreign establishment that manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new animal drug, that is imported or offered for import into the United States. When operations are conducted at more than one establishment and common ownership and control among all the establishments exists, the parent, subsidiary, or affiliate company may submit registration information for all establishments.

​Thank you all! I was recently at the AAM conference and was able to discuss with a few people from industry but also with some people from the FDA; the different FDA representatives I spoke to confirmed that this is a "gray" area for API intermediates manufacturers, they should have an FEI number but don't necessarily need to register.

I also sent an email to the eDRLS group and they also confirmed that there is no requirement for API intermediate manufacturers to register their establishment under 21 CFR 207.

​Good morning everyone,

Do you know of any requirements/regulations that state that Drug Substance Intermediate Manufacturers need to register their establishment with the FDA? The manufacturer is located outside of the US and we have recently received a question as part of a CRL asking for the manufacturer's FEI number. The establishment registration sections on FDA's website and in the CFR (207) are specific to drug substance/product; not intermediate.

Thanks,

Sabrina

@207.17   Who must register?

(a) Unless exempt under section 510(g) of the Federal Food, Drug, and Cosmetic Act or this part, all manufacturers, repackers, relabelers, and salvagers must register each domestic establishment that manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new animal drug, and each foreign establishment that manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new animal drug, that is imported or offered for import into the United States. When operations are conducted at more than one establishment and common ownership and control among all the establishments exists, the parent, subsidiary, or affiliate company may submit registration information for all establishments.

​Good morning everyone,

Do you know of any requirements/regulations that state that Drug Substance Intermediate Manufacturers need to register their establishment with the FDA? The manufacturer is located outside of the US and we have recently received a question as part of a CRL asking for the manufacturer's FEI number. The establishment registration sections on FDA's website and in the CFR (207) are specific to drug substance/product; not intermediate.

Thanks,

Sabrina

@207.17   Who must register?

(a) Unless exempt under section 510(g) of the Federal Food, Drug, and Cosmetic Act or this part, all manufacturers, repackers, relabelers, and salvagers must register each domestic establishment that manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new animal drug, and each foreign establishment that manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new animal drug, that is imported or offered for import into the United States. When operations are conducted at more than one establishment and common ownership and control among all the establishments exists, the parent, subsidiary, or affiliate company may submit registration information for all establishments.

"unfinished drugs requiring further processing....." what do you call this? This require drug listing so there seems to be a conflict!!

​Good morning everyone,

Do you know of any requirements/regulations that state that Drug Substance Intermediate Manufacturers need to register their establishment with the FDA? The manufacturer is located outside of the US and we have recently received a question as part of a CRL asking for the manufacturer's FEI number. The establishment registration sections on FDA's website and in the CFR (207) are specific to drug substance/product; not intermediate.

Thanks,

Sabrina

@207.17   Who must register?

(a) Unless exempt under section 510(g) of the Federal Food, Drug, and Cosmetic Act or this part, all manufacturers, repackers, relabelers, and salvagers must register each domestic establishment that manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new animal drug, and each foreign establishment that manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new animal drug, that is imported or offered for import into the United States. When operations are conducted at more than one establishment and common ownership and control among all the establishments exists, the parent, subsidiary, or affiliate company may submit registration information for all establishments.

"unfinished drugs requiring further processing....." what do you call this? This require drug listing so there seems to be a conflict!!

​Good morning everyone,

Do you know of any requirements/regulations that state that Drug Substance Intermediate Manufacturers need to register their establishment with the FDA? The manufacturer is located outside of the US and we have recently received a question as part of a CRL asking for the manufacturer's FEI number. The establishment registration sections on FDA's website and in the CFR (207) are specific to drug substance/product; not intermediate.

Thanks,

Sabrina

@207.17   Who must register?

(a) Unless exempt under section 510(g) of the Federal Food, Drug, and Cosmetic Act or this part, all manufacturers, repackers, relabelers, and salvagers must register each domestic establishment that manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new animal drug, and each foreign establishment that manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new animal drug, that is imported or offered for import into the United States. When operations are conducted at more than one establishment and common ownership and control among all the establishments exists, the parent, subsidiary, or affiliate company may submit registration information for all establishments.

"unfinished drugs requiring further processing....." what do you call this? This require drug listing so there seems to be a conflict!!

​Good morning everyone,

Do you know of any requirements/regulations that state that Drug Substance Intermediate Manufacturers need to register their establishment with the FDA? The manufacturer is located outside of the US and we have recently received a question as part of a CRL asking for the manufacturer's FEI number. The establishment registration sections on FDA's website and in the CFR (207) are specific to drug substance/product; not intermediate.

Thanks,

Sabrina

@207.17   Who must register?

(a) Unless exempt under section 510(g) of the Federal Food, Drug, and Cosmetic Act or this part, all manufacturers, repackers, relabelers, and salvagers must register each domestic establishment that manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new animal drug, and each foreign establishment that manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new animal drug, that is imported or offered for import into the United States. When operations are conducted at more than one establishment and common ownership and control among all the establishments exists, the parent, subsidiary, or affiliate company may submit registration information for all establishments.

"unfinished drugs requiring further processing....." what do you call this? This require drug listing so there seems to be a conflict!!

​Good morning everyone,

Do you know of any requirements/regulations that state that Drug Substance Intermediate Manufacturers need to register their establishment with the FDA? The manufacturer is located outside of the US and we have recently received a question as part of a CRL asking for the manufacturer's FEI number. The establishment registration sections on FDA's website and in the CFR (207) are specific to drug substance/product; not intermediate.

Thanks,

Sabrina

@207.17   Who must register?

(a) Unless exempt under section 510(g) of the Federal Food, Drug, and Cosmetic Act or this part, all manufacturers, repackers, relabelers, and salvagers must register each domestic establishment that manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new animal drug, and each foreign establishment that manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new animal drug, that is imported or offered for import into the United States. When operations are conducted at more than one establishment and common ownership and control among all the establishments exists, the parent, subsidiary, or affiliate company may submit registration information for all establishments.