noncombinations was purely random in my mind, until i googled it ... and behold ... there's a federal office of combination products ... [check the FAQs Maam - as Joe Friday would probably say today]
Of course you can skip over to the Office of Combination Products
Note though, that despite the discussion of NonCombination Products in the FAQ ... very little direct definition of NonCombination Products is ever given. So if you are not a combination product, satisfying the rigorous definition of combination products, then you must be a NonCombination product. There ... Tat! I don't know if this adds to the discussion ... but the finger tips had to do their strolling over the keyboard on this.
So just in case you're wondering ... here are some of the federal definitions ...
What is a combination product?
A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Under 21 CFR 3.2 (e), a combination product is defined to include:
1. A product comprised of two or more regulated components (i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity;
2. Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;
3. A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where, upon approval of the proposed product, the labeling of the approved product would need to be changed (e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose); or
4. Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.
What are some examples of combination products?
Examples of combination products where the components are physically, chemically or otherwise combined (21 CFR 3.2(e)(1)):
* Monoclonal antibody combined with a therapeutic drug
* Device coated or impregnated with a drug or biologic
o Drug-eluting stent; pacing lead with steroid-coated tip; catheter with antimicrobial coating; condom with spermicide
o Skin substitutes with cellular components; orthopedic implant with growth factors
* Prefilled syringes, insulin injector pens, metered dose inhalers, transdermal patches
Examples of combination products where the components are packaged together (21 CFR 3.2(e)(2)):
* Drug or biological product packaged with a delivery device
* Surgical tray with surgical instruments, drapes, and lidocaine or alcohol swabs
Examples of combination products where the components are separately provided but labeled for use together (21 CFR 3.2(e)(3) or (e)(4)):
* Photosensitizing drug and activating laser/light source
* Iontophoretic drug delivery patch and controller
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