Food and Drug Administration

Posted on Dec 7, 2011 in Medicine

The Food and Drug Administration, through its Code of Federal Regulations (CFR) in Title 21 requires that food, drugs, cosmetics, biologics, radiation-emitting electronic products, and medical devices comply with the labeling regulatory requirements. The general device labelling requirements are specified in part 801 of CFR 21.Some of other specific requirements are specified in detail in specific parts of CFR 21. They are:

1. In Vitro Diagnostic Products – 21 CFR Part 809.
2. Investigational Device Exemptions — 21 CFR Parts 812.
3. Good Manufacturing Practices — 21 CFR Parts 820.
4. General Electronic Products — 21 CFR Parts 1010.

Companies that do not meet the requirements of labeling as required by FDA will face action from FDA under the Federal Food, Drug and Cosmetic Act (FFDCA) that governs regulated products compliance.

General Device Labeling Requirements – The minimum labeling requirements are as follows:

1. Name and place of business: The device shall contain the complete name and place of business of manufacturer, packer, or distributor and the information must be qualified by an appropriate statement.

2. Intended use: If the product is used by either the packer, seller or distributor for purposes other than those intended for by the manufacturer, adequate labeling must be provided.

3. Directions for use: Directions under which a layman can use the device safety must be provided on the label like the dosage, frequency, duration, method of application and any necessary preparations must be included.

Exemptions – The exemptions are as under:

1. Prescription Device.
2. Retail Exemption.
3. Commonly Known Directions.
4. in Vitro Diagnostics.
5. Used in Manufacturing.
6. Used in Teaching, Research, or Law Enforcement.

Expiration of Exemptions:

The exemptions for the expire if they are used for purposes other than the exempted purposes.

Specific device labeling requirements – The specific requirements for device labeling of the following are mentioned in separate sections of the title and need to be adhered to:

1. Denture repair kits.
2. Impact resistant lenses in sunglasses and eyeglasses.
3. Ozone emission levels.
4. Chlorofluorocarbon propellants.
5. Hearing aids.
6. Menstrual tampons.
7. Chlorofluorocarbons or other ozone depleting substances.
8. Latex Condoms.
9. Devices containing natural rubber.

Misbranding or false labelling:

If the medical devices labeling does not conform to the requirements and includes any false, misleading or objectionable labeling it is considered as misbranding for which action is taken for misbranding under the Federal Food, Drug and Cosmetic (FFD&C) Act.

Understand What Naturopathic Medicine Entails

Posted on Dec 3, 2011 in Medicine

There are various forms of medicine that most people do not understand. People usually visit the hospitals and get medication without really knowing what is entailed in the medicine. The naturopathic medicine is the health care system, which is composed of both the traditional and the modern knowledge. It is one of the non-artificial forms of medicine.

The main function of the naturopathic medication is to treat and heal the causes of disease, while addressing the underlying genesis of the disease. If you examine the logic behind the symptoms of a disease, then you would ascertain the fact that symptoms signal the malfunction or disorder of tissues inside the body.

Naturopathic medicine is used to treat both the acute and the chronic conditions. However, naturopathic treatments are not just given to anyone without pondering over some considerations. Additionally, you are given the prescriptions based on your psychological, social, structural, spiritual and the environmental factors.

Moreover, you would be stipulated to the Chinese acupuncture, botanical medicine, clinical nutrition, hydrotherapy and so on, if you want to have a lifestyle change. Hence, there are various other complicated procedures involved in the medication. Stringent measures are taken to ensure that the professional treatment is being given to the attendants. After all, professionalism is the key factor that has to be considered at all costs.

In Naturopathic medicine, a professional doctor is authorized to carry out the procedure. Nonetheless, it is also the responsibility of the patient to ensure the doctor to whom he is consulting is an expert in his field or not. A human health is a very sacred thing. Thus, one has to take care of it as meticulously as possible. However, there are people who believe in this treatment by stating myriad of wonders and miracles it performed. Whereas are others, who believe it is ineffective.

Naturopathic medicine is given by naturopathic practitioners; these practitioners can be bifurcated in two groups. These groups are traditional naturopaths and the naturopathic physicians. As far as the naturopathic physicians are concerned, they apply the principles of naturopathy with the mix of conventional medical. Their methods consist of a lot of modalities, which ranges from standard evidence to homeopathy. This is a practice that is being conducted in many countries, especially in the United States and Canada.

People need to know about the naturopathic medicine. Moreover, there are a lot of methodological underpinning of the naturopathy that goes in order to conflict with the evidence-based medicine.

Hangover Medicine – Find Relief And How To Beat A Hangover With Medicine

Posted on Nov 25, 2011 in Medicine

The more traditional amongst us would be looking for hangover medicine to find the most effective cure to get rid of a hangover fast. After all, that’s the whole point in medicine. Does anything really work? Is there a real solution or a remedy for hangovers in pharmaceutical form?

Nothing works, except for abstaining

I’m tired of people smugly advising us to abstain from drinking in order to avoid getting hungover. If I wanted to abstain from drinking alcohol, I wouldn’t be asking how to fix my hangover in the first place right? And anyway, by the time I’m looking for a fix, it’s probably far too late to abstain anyway. Let’s face it, you’re hungover and you want some kind of hangover medicine to fix it fast.

Take a multivitamin before sleeping

Taking a multivitamin before sleeping and after drinking with some water helps prevent a hangover. It replaces and even boosts levels of nutrients that we lose during our alcohol session. Most times, you’ll wake up with a fairly clear head and much more energy than you would have otherwise.

There are multivitamins which help detox your liver too, getting rid of your hangover faster and improving liver health. This is much better than any old multivitamin pill. The best one? One which has all the right electrolytes to help you wake up feeling fairly clear-headed and more energetic and also helps protect your liver.

Avoid Tylenol or Paracetamol after drinking

These two forms of medication are great when you have a cold, a nasty headache and the shivers. However, having them the day after alcohol isn’t recommended. They take a lot of work for your liver to break them down. So don’t go near these to get rid of your hangovers. You body will take a severe beating.

Commercial cures

We’ve all heard of the various new commercial hangover cures that come on the market, claiming to be the newest surefire solution to stopping hangovers forever. I go more into this when I write about commercial hangover cures. I don’t necessarily recommend any particular one.

For example, Chaser hangover cure is meant to be taken between drinks. I can’t tell you if it works. I’m sure it does for some people because it’s been around for a while.

However, taking pills between drinks is just not so convenient and I’d forget to do it. Not to mention, I’d have to carry them around with me, and probably get into trouble if anyone saw me taking pills in a nightclub.

Vitamin based cures

Most other commercial remedies on the market are focused more on preventing hangovers rather than treating hangovers. But I tell you how to do that here, and as long as you have some vitamins in the cupboard and preferably some milk thistle around, then you’ll be making your own, homebrew style hangover prevention kit!