Everything buyers ask before opening an account
Who makes your products?
USA Gold Standard is your contracting party: one account, one agreement, one invoice. Every product is finished and shipped from the United States. Patient-specific prescriptions are compounded and dispensed by a state-licensed 503A pharmacy; office-use stock is compounded by a registered 503B outsourcing facility. Licence numbers and raw-material certificates of analysis are shared during account review; finished-product testing is quoted per lot.
Is your clinical supply 503A or 503B?
Both, where the product and destination qualify. Patient-specific prescriptions are compounded and dispensed by a state-licensed 503A pharmacy. Office-use stock is compounded by a registered 503B outsourcing facility. Licence numbers are shared during account review, with eligibility confirmed product by product. Compounded products are not FDA-approved.
Can I audit your supply chain?
Audit and documentation requests are handled during account review. Send your supplier qualification requirements up front (questionnaire, documents, site visit) and we confirm in writing what can be provided before you commit. Facility documentation is reviewed after account approval, under NDA; site visits are arranged in writing. After approval, what we can disclose is set out in writing before your first order.
Can I see a certificate of analysis?
Yes. A raw-material certificate of analysis is available for every product. Finished-product testing through a partner laboratory is available on request and quoted per lot.
Where are your products made?
Our supply partner is based in the United States. Active ingredients are imported, so we make no Made-in-USA claims; country of manufacture is stated for each product in writing with your quote.
How do I know the contents match the label?
Only finished-product testing shows what is in a finished lot. It is available through a partner laboratory on request and quoted per lot. Raw-material certificates of analysis are also available for every product.
What about cold chain and stability?
Lyophilized vials ship and store cold-chain. Dual-chamber pens stay unmixed until first use, then go in the refrigerator. Topicals, oral formats, mints, gum and chews are shelf-stable. Your quote states the storage and shipping conditions for every product you order.
What are the minimums and lead times?
Minimums are quoted per format and program, and production lead time is confirmed in writing with every quote.
Can you private-label skincare under my brand?
Yes, for cosmetics. Three levels: our brand, your label on our standard packaging, and fully custom packaging. Standard packaging is included in program pricing, and formulation changes to cosmetic products are quoted quickly once we have a complete request.
How does your pricing compare with the suppliers I use now?
We don't publish prices. Approved accounts receive a volume-tiered price list. Send current invoice line items with your application and we quote like-for-like.
Do you offer payment terms or credit?
New accounts start on prepayment. Terms are reviewed by application once there is a trading history.
What happens with returns and recalls?
We publish a written complaint, quarantine and recall procedure on our Quality page. Report an issue with the lot number and we open a case the same business day.
Can I get exclusivity or a territory?
Exclusivity can be agreed for qualifying volume commitments, defined in writing by product, channel and territory.
Can you ship to Dubai or the UK?
International orders are reviewed case by case. The importer of record must hold the licences the destination market requires, and we confirm product eligibility and documentation before quoting.
Why haven't I heard of you?
USA Gold Standard is a trade-supply business launching to the trade now. It exists to give clinics and distributors one account for formats they currently buy from several suppliers.
Can my team become reps?
Yes. Medical sales organizations and independent reps can apply to the rep program. Compensation and territory are agreed in writing after review.