Actual - Legal

According to the Small Business Administration, www.sba.gov, your small business has to comply with numerous local, state and

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

federal regulations. Research the regulations carefully to avoid penalties and other serious consequences. The following is a non-ex

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

Examples of combination products may in

haustive list of the most common regulations that affect small businesses.

Business Licenses – State, city, or county.

Ce

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

rtificate of Occupancy -- If you are planning to occupy a new or used building.

Business Organization -- Consult a tax ac

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

countant or attorney prior to deciding which form of legal structure is right for your business.

Fictitious Business Names --

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

Combination pro

If you use a “dba,” you may have to register the fictitious name pursuant to the Trade Name Registration Act.

Protecting Your Id

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

ea -- Apply for trade name, trademark, patent and copyright protection with the state and federal government

Tax Requirements

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

/b> -- You must withhold federal income taxes, state income taxes and FICA (Social Security) from wages paid to employees.

Federa

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

l Employer Identification Number -- Apply at www.irs.gov.

State tax information – Apply at your state’s website or

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

call your state government.

Federal Self-Employment Tax – Apply at www.irs.gov.

Business Insurance -- You mus

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

t have business insurance to protect your business such as: Liability, Property, Business Interruption, Key Man, Automobile, Office

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

Following aspects would a

and Director, Home Office, Errors and Omissions.

Sales Tax Number – Required for retail purchases, rental, storage, and consu

dd to the challenges in developing combination products:

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

mption of tangible personal property and certain services.

Unemployment Insurance Tax -- required by the state if the company

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

has one or more employees for 20 weeks in a calendar year or pays gross wages of $1,500 or more in a calendar year.

Immigration

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

ct – Requires Employment Eligibility Verification Form I-9.

Health and Safety -- The Federal Occupational Safety and Heal

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

th Administration (OSHA) outlines specific health and safety standards.

Workers' Compensation -- If business employs three or

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

Professional from academic institutions, pharmaceutical industries, health care indust

more people.

Minimum Wage --All business entities are subject to the federal minimum wage, overtime and child labor laws.

<

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

b>Bar Coding -- The Uniform Code Council, Inc. assigns a manufacturers' ID code on the packaged products you sell.

For more info

.

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

rmation about these and other important business and legal topics, please visit our website at http://www.IndigoBusinessSolutions.

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

Companies that provide selfless information through particip

net, Copyright 2006. Indigo Business Solutions is a registered trade name.

The future of your business starts here.

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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Actual - Small Business Regulations

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