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The real danger to the quality of the water is not industrial wastes but human created wastes that comes from residential neighborhoods. This pollution is called Nonpoint source (NPS) pollution.

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

This type of pollution is caused by rainfall or melting snow that runs over cement and parking lots and carries insecticide, oil and gas, fertilizers and herbicides that are sprayed on gardens and

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

Examples of combination products may in

grass directly to our waterways.

Other pollutants are the oil, grease or toxic chemicals that are produced as a result of urban sprawl. Many people ignore the warnings of our governmental agencie

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

and continue to use poisonous substances on their lawns and in their day-to-day life.

These pollutants end up in our water resources. As a result, pollution from these sources are cited by many s

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

ate agencies as “uncontrolled pollution” Stormwater runoff pollution impacts the quality of water and will eventually impact where and how humans can live.

If left unchecked, the water supply wi

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

Combination pro

l not support life. While the EPA has created programs under the Clean Water Act to protect the quality of our water, the prevention of pollution is dependent on individuals learning to prevent pol

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

lution.

Most of the Pollution Prevention programs are managed by the state environmental agencies and the rules and regulations are created for larger business sectors. The exceptions to this r

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

le are in the states of:

Massachusetts
New Mexico
Alaska
Idaho
New Hampshire

In these states, the EPA retains complete authority. According to the EPA, states are more co

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

cerned about nonpoint source pollution. States report that this pollution is the leading remaining cause of water quality problems.

Phase I of National Pollutant Discharge Elimination System(NPDE

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

) requires all point sources discharging pollutants into waters of the United States to obtain a permit. This program was designed for cities with populations of more than 100,000. The NPDES also

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

argeted large industrial and construction sites. The statues required that industries and construction sites begin treating storm water runoff from their locations.

These restrictions limited and

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

Following aspects would a

reduced the pollution from these industrial sites. Site pollution control maintenance is a priority for most industries. Heavy fines and penalties are levied against those industries when they d

dd to the challenges in developing combination products:

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

not adhere to the EPA guidelines. However the pollution from the residential areas continue to increase. It is difficult to pinpoint residential hotspots.

Phase II of NPDES was announced in Dec

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

mber 1999 and required that more than 5,000 municipalities and all new developments of one acre or larger implement Best Management Practices ’s (BMP's) for stormwater treatment to the maximum exte

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

t that was practical.

The compliance to these BMP's was also implemented. The data indicated that pollution was reduced and controlled from those municipalities that were regulated. But the redu

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

ed level of pollution from industrial and commercial sites was ineffective because the level of pollution from non-industrial locations continued to increase.

The effects of nonpoint source pol

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

Professional from academic institutions, pharmaceutical industries, health care indust

lutants on specific waters vary within separate municipalities. Governmental agencies have released critical data that confirms that nonpoint source pollution is the leading cause of water polluti

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

n. This type of pollution is difficult to control or to legislate because the source is so widespread and not easily contained. This type of pollution is created by the public at large.

The focu

.

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

of state environmental agencies is to increase public awareness of this problem. Implementing programs at the community level will provide strategies to manage nonpoint source pollution.

These po

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

Companies that provide selfless information through particip

lutants have harmful effects on drinking water, recreation, fisheries, and wildlife. It is the responsibility of industry as well as individual citizens to work together to protect our water supply

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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