規制対象機械の輸入にDEAライセンスを取得するにはどうすればいいですか？

導入

機器の輸入など カプセル充填機, タブレットプレス、および関連する包装システムを米国に持ち込むには、有効な DEAライセンス麻薬取締局（DEA）の許可がなければ、規制対象機械の輸送は米国税関を通関できません。申請手続きを効率化するには、DEAの公式ポータル（apps.deadiversion.usdoj.gov/tem/spri spring/login)にアクセスし、アカウントを登録してください。

Do health supplement companies in the United States need a DEA license to purchase capsule filling machines from Chinese manufacturers?
Answer: Yes, they do！

To be more precise, instead of requiring a long-term DEA registration license like a pharmacy, you must declare to the DEA and obtain a one-time import permit before importing the machine.

The specific explanation is as follows:

Why you need a permit: In the United States, capsule filling machines and tablet presses are classified as "regulated machines" by the DEA, regardless of what you use them to produce. This is because such equipment may be abused to illegally manufacture drugs or counterfeit drugs. Therefore, the DEA strictly controls the import of such machines.

The key lies in the "import" behavior: The focus of supervision is on the "import" link. Even if your final product is a completely legal health product (such as cellulose), as long as you buy it from China and ship it to the United States, you must comply with DEA regulations.

Specific process:

Before the machine is shipped from China, your US company must submit an application form called Form 452 (Machine Import Application) to the DEA.

You need to fill in your company information, Chinese seller information, and detailed specifications of the machine in the form.

The most important step is that you must prove on the form that you are purchasing this machine for "legitimate commercial use", such as producing health supplements.

Only after the DEA reviews and approves your application can the machine be cleared by the US Customs and Border Protection (CBP). Without this pre-approval, the machine is likely to be seized or destroyed by customs after it arrives in the United States.

Regardless of machine size and power, this regulation applies to all types and sizes of capsule filling machines, whether small, low-power, manual, or fully automatic, and must be declared.

2019 年に Journal of Pharmaceutical Sciences に掲載された調査で、研究者らは、適切に構造化された輸入コンプライアンス プログラムを備えた組織は承認時間を最大 30% 短縮したことを観察しました¹。当社の明確で能動態的な手順に従うことで、DEA フォーム 452 (「規制対象機械の輸入」) を記入し、DEA ライセンスを受け取るまで取引を追跡する方法を学習できます。