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Lip care
All Containers›Shop by use case›Lip care›Growing the operation›Having somebody else make itShop all lip care →
Growing the operation

Having somebody else make it

By Dwight Davis, Founder

Updated

On this page5

Contract filling is a well-established route in this category and the cheapest way past the hand filling ceiling.

What a co-packer is doing for you

Buying materials, making to your formula, filling, labeling and often packing to a case.

What they are not doing is developing your product. A co-packer will make what you specify; they will not tell you your formula grains, and they will not own the consequence if it does.

What they need from you

A formula in percentages with the grade and supplier of every material.

A process with real numbers, not "melt and pour".

A specification: what a good unit is, so there is something to accept or reject against.

Approved packaging components, and label artwork that is already compliant.

Which is why the recipe-to-product work pays twice. A maker with a real formula document can be quoted in a week; a maker with a recipe cannot be quoted at all.

Minimums are the constraint

Co-packer minimums are usually thousands of units per run, per SKU. Three flavors at minimum is a lot of finished stock and a lot of cash.

And a run is a run: you cannot reorder two hundred in a hurry. Plan inventory against their lead time rather than against your sales rate.

The regime follows the product

If the product is an OTC monograph drug, the filler has to be operating under cGMP and registered as a drug establishment. Not every cosmetic filler is, and it is the first question to ask rather than an assumption to make.

Their registration does not remove your obligations as the firm named on the label. You are responsible for what is made on your behalf, which is why the specification and the acceptance criteria matter more in this arrangement, not less.

References

21 CFR Parts 210 and 211, Current Good Manufacturing Practice for finished pharmaceuticals, which apply to OTC monograph drug products with no exemption based on the size of the business. ecfr.gov
FDA drug establishment registration and drug listing: an NDC labeler code, product listing, and annual renewal between 1 October and 31 December, required of anyone manufacturing, repacking or relabeling an OTC drug product. fda.gov
US Food and Drug Administration. Registration & Listing of Cosmetic Product Facilities and Products under MoCRA, including the small-business exemptions and what they do not cover. fda.gov
Written from the federal regulation and FDA guidance named on each page, not from a laboratory or a legal practice. Whether a particular formula and a particular label make a cosmetic or a drug is a determination about your product, and this is not that determination.