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Do you do Reiki energy treatments for your family and friends? Have you thought about turning your interest into a business? If you'd like to know a little more about

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

how to develop a Reiki practice, here are a few tips about the legal aspects of the business.

Licensing
Right now (2007) in the U.S. there are

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

no government-issued licenses to practice Reiki (as there are for doctors, nurses, etc.). But Reiki might be included in your state or local massage licensing laws -

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

f there are any - so it's a good idea to check those to see whether they cover Reiki. There's a good chance they won't. But if they do, you'll have to get licensed to

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

do massage therapy in order to practice Reiki.

This kind of licensing is different from business licensing. While you might not need a "license to practice," you'll

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

lmost certainly need a business license. Business licensing requirements differ, so check with your city/county administrative office or local chamber of commerce for

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

more information.

Insurance
There are many different kinds of insurance for individuals and businesses, but what I'm referring to here is liabi

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ity insurance. This may not seem important since you're not manipulating tissue (like a massage therapist does), but it is. When you give someone a Reiki treatment yo

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

'll be touching them with the intent to facilitate healing, and some people will see that as medical - especially if they have a medical condition. In this lawsuit-ha

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

py country it's best to be protected.

Most professional massage therapy organizations offer liability insurance with membership. This insurance usually also covers o

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

her modalities - like Reiki. And if you don't do massage, don't worry - most of these organizations will accept Reiki practitioners.

Taxes
If y

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

u've always worked for someone else you may have noticed taxes being deducted from your paycheck. However, you may not have realized that you were paying only a porti

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

n of the total tax; your employer was paying the other portion. When you're self-employed, or working for someone else on a contract basis, you still have to pay taxe

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

, but now they'll be higher because you'll have to cover the employer's portion as well as your own.

So, the bad news is - more taxes. The good news (of a sort) is t

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

at you won't be paying them in one lump sum every April. Instead, you'll be paying quarterly, which is at a least a bit easier on your budget. Just be sure to save so

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

e of your earnings, preferably in an interest-bearing account, so the money's there when you need to make a payment.

Taxes of any kind can be confusing. The IRS has

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

n entire website full of information and forms and also toll-free numbers to help you out. But if your business grows you'll probably want to enlist the services of a

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

bookkeeper or accountant. Yes, it's an added expense, but you may be able to keep costs down by trading services.

Final Thoughts
Legal issues c

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

n sound confusing, but they don't have to be. When you're just starting out try to take it one step at a time, dealing with each item as you need to. You'll find that

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

once you get past the initial steps things will smooth out. Then you'll be able to focus once again on why you're doing all of this - to help people with Reiki energy

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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