Custom manufacturing allows us to work with

creative customers on the forefront of product development. 

We love being involved in new ideas and the next big thing –

but there are limits to custom manufacturing.

 

• We won’t make patches out of active ingredients that we know won’t work.   See article.
• ACT doesn’t make prescription drugs.  (We do make OTC drugs – just ask!)
• We don’t make steroid patches.
• No patches with DMAA, ephedra, ephedrine alkaloids, or fenfluramine.
• Although we do include guarana and/or green tea extract in some of our patches, we cannot produce patches with more than 300mg/serving of any form of caffeine.  (Caffeine from coffee beans won’t deliver through the epidermis).
• We won’t court FDA reprimand by combining OTC drugs with active ingredients that aren’t in their monograph.

 

Legal Advice

 

• ACT is happy to provide our customers with the expertise that comes from having been in the business for over 36 years.
• We do not, however, provide legal advice, particularly when it comes to the process of starting a New Drug Application with the FDA.   You are going to need experienced legal counsel.

 

Export/Import Regulations

 

• Every country has its own laws surrounding the manufacture and consumption of supplements and OTC drugs.   These laws often vary substantially from the ones here in the United States, up to and including categorizing topical patches as medical devices.
• The country into which you want to import may require testing or certifications that aren’t required here.   We don’t pretend to be experts in international law, and we don’t keep track of the regulations in other countries, just our own.
• If you intend to export your product, you need to consult with experts in export law.
• We are happy to support your endeavor by providing paperwork, arranging for testing, etc., but these generally need to be arranged prior to manufacture.
• ACT does not export directly.   We will ship completed product to your United States address and you are responsible for shipments, taxes and paperwork from that point forward.

 

Art Department

 

• ACT doesn’t have a designer on staff.  We are delighted to ship you fully ready-to-sell product, but the art itself is your responsibility.  You will need to provide us with all necessary artwork at the time you submit your purchase order.    This should include barcodes and may include a QR code for certain products.
• We don’t offer legal advice on what should or should not be on your packaging; unless you are making a non-OTC topical patch, in which case we request that you include the FDA disclaimer.
• If you’d like an expiration date on your packaging, we will need to see your stability test results or arrange same for you so that we can give you an accurate date.