Source: Food and Drug Administration (FDA)

For safety reasons, FDA recommends that a few, select medicines be disposed of by flushing down the sink or toilet.
Accidental exposure to these medicines could be harmful or sometimes deadly, even in a single dose, if they are used by someone other than the person the medicine was prescribed for.

Flushing these medicines down the sink or toilet removes this risk from the home.
Please see the list of medicines recommended for disposal by flushing.

This question and answer page provides additional details on why FDA recommends to flush certain medicines.

1. What are FDA's recommendations for removing unused medicines from the home?
2. Why do the medicines on this list have directions for disposal by flushing and other medicines do not? What is the rationale for this policy?
3. How big of a problem is accidental exposure to medicine in the United States?
4. Does flushing the medicines on this list down the toilet or sink pose a risk to human health or the environment? How have considerations about medicines in the environment informed FDA’s recommendations about the disposal of medicines from the home?
5. Can the medicines that FDA recommends for disposal by flushing be eliminated from the home in some other manner; for example, by drug-take back programs or returning the medicine to the pharmacy?
6. I live in an assisted living community and take my own medicines. I have prescription medicines that I no longer need. How can I safely dispose of them?

1: What are FDA's recommendations for removing unused medicines from the home?
FDA supports the responsible disposal of medicines from the home. Almost all medicines can be safely disposed of by using medicine take-back programs or using U.S. Drug Enforcement Agency (DEA)-authorized collectors.
When these options are not available, consumers may also dispose of unneeded medicine in their household trash.

DEA-authorized collectors safely and securely collect and dispose of pharmaceutical controlled substances and other prescription drugs.
In your community, authorized collection sites may be retail pharmacies, hospital or clinic pharmacies, and law enforcement locations.
Some pharmacies may also offer mail-back envelopes to assist consumers in safely disposing of their unused medicines through the U.S. Mail.

Consumers can visit the DEA’s website for more information about drug disposal and to locate an authorized collector in their area.
Consumers may also call the DEA Office of Diversion Control’s Registration Call Center at 1-800-882-9539 to find an authorized collector in their community.
Local law enforcement agencies may also sponsor medicine take-back programs in your community. Contact your city or county government for more information on local drug take-back programs.
The U.S. Drug Enforcement Administration (DEA) periodically hosts National Prescription Drug Take-Back events where collection sites are set up in communities nationwide for safe disposal of prescription drugs.

If a take-back or mail back program is not available to you, most other unused or expired medicines can be disposed of in your household trash.
First, mix the medicines (do not crush tablets or capsules) with an unpalatable substance such as dirt, kitty litter, or used coffee grounds.
Then place the mixture in a container such as a zip-top or sealable plastic bag, and throw the container away in your household trash.
Before throwing out your empty pill bottle or other empty medicine packaging remember to scratch out all personal information on the prescription label to make it unreadable.

There are, however, a few prescription medicines that contain controlled substances and are especially harmful if taken accidentally by someone other than the patient.
These medicines should not be thrown in the trash, because this method may still provide an opportunity for a child or pet to accidentally take the medicine. If a DEA-authorized collector or drug take-back program is not available, FDA recommends that these medicines be disposed of by flushing when they are no longer needed.
The list of medicines recommended for disposal by flushing can be seen at this link.

2: Why do the medicines on this list have directions for disposal by flushing and other medicines do not? What is the rationale for this policy?
The medicines recommended for disposal by flushing are safe and effective when used as prescribed, but they could be especially harmful to a child, pet, or others if taken accidentally. Some of the possible harmful effects include breathing difficulties or heart problems, which could lead to death.
For these reasons, FDA recommends that when it isn’t possible to return these medicines through a take-back program or to a DEA-authorized collector via a collection box or mail-back program, consumers should flush them down the sink or toilet to immediately and permanently remove this risk from their home.

Reducing the risk of harm from accidental exposure to this small, select list of medicines is of utmost concern to FDA and we believe that this risk far outweighs any potential risk to human health or the environment that may come from disposal by flushing.
FDA continues to work with and encourage manufacturers of these medicines to develop alternative, safe disposal systems.

3: How big of a problem is accidental exposure to medicine in the United States?
Accidental exposure to medicine in the home is a major source of unintentional poisonings in the United States.

• In 2007, there were 255,732 cases of improper medicine use reported to Poison Control Centers in the United States. Approximately 9% of these cases (23,783) involved accidental exposure to another person’s medicine. Approximately 5,000 of these accidental exposure cases involved children 6 years and younger.
• Keeping medicines after they are no longer needed creates an unnecessary health risk in the home, especially if there are children present. Even child resistant containers cannot completely prevent a child from taking medicines that belong to someone else. In a study that looked at cases of accidental child exposure to a grandparent’s medicine, 45% of cases involved medicines stored in child-resistant containers.

Cases of inadvertent exposure to some of these medicines were published in the American Association of Poison Control Centers’ 2007 annual report.
A case of accidental exposure to one of these medicines has also been published in the literature.
Below are summaries of some of these cases to illustrate how some medicines can result in fatality if they are accidentally taken by children.

• A 2-year old male was found with an open bottle of methadone, an opioid drug that can be used for the management of pain. The child was taken to the emergency department and appropriate actions (e.g., activated charcoal) were taken to flush the medicine from his system. Following these interventions, the child was discharged from the hospital. Later that same day, he was found not breathing and without a heartbeat. There was vomit around his mouth. Emergency services were called, but attempts at resuscitation were ineffective and the child died.
• A 4-year old female was found not breathing by her grandparents in their home. Resuscitation was attempted, but was ineffective and the child died. During the autopsy, a transdermal fentanyl patch, a strong opioid pain medicine, was found in the child’s gastrointestinal tract. Apparently, the child found a discarded patch in the trash and ingested it, resulting in a massive overdose of fentanyl.
• A 2-year old female was found in her home rubbing her mouth and staggering. Before entering the house, she had been playing outside and her parent, based on her behavior, believed that she had ingested something. Additional symptoms, including tiredness and abdominal pain, later emerged. She was brought to the emergency room and her physical examination revealed no remarkable signs of distress. The child was discharged to her parent’s care. The following morning, the child was found unresponsive. Emergency services were called and CPR was begun. The child was pronounced dead upon arrival to the hospital. A blood sample taken around the time of death was positive for oxycodone.

4: Does flushing the medicines on this list down the toilet or sink pose a risk to human health or the environment? How have considerations about medicines in the environment informed FDA’s recommendations about the disposal of medicines from the home?
FDA is aware of reports of very low but measurable levels of medicines in surface waters such as rivers and streams, and to a lesser extent in drinking water. Disposal of these select few medicines by flushing would contribute only a small fraction of the total amount of medicine found in our surface and drinking water.
The majority of medicines found in water are a result of the body’s natural routes of drug elimination (in urine or feces).
Based on the available data, FDA believes that the known risk of harm to humans from accidental exposure to these medicines far outweighs any potential risk to humans or the environment from flushing them.

To date, scientists have found no evidence of harmful effects to human health from medicines in the environment. In addition, to better understand the human health and ecological risks from medicines in our water, FDA works with other agencies, including the U.S. Environmental Protection Agency (EPA).
Still, to reduce overall medicine levels in our waters, FDA recommends that consumers first consider disposing of these drugs as quickly as possible through medicine take-back programs or DEA-authorized collectors before flushing down the sink or toilet.

5: Can the medicines that FDA recommends for disposal by flushing be eliminated from the home in some other manner; for example, by drug-take back programs or returning the medicine to the pharmacy?
Yes, the medicines that FDA recommends for disposal by flushing can be disposed of by other methods. For example, consumers can return these medicines to a DEA-authorized collector through secure collection receptacles or mail-back packages, and to local and national medicine take-back programs.
Authorized collection sites may be retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. However, since these medicines may be especially harmful to a child, pet, or anyone else if taken accidentally, it is important to store them safely and securely until disposal.

Your local law enforcement agency may sponsor drug take-back events that can accept medicines containing controlled substances. If there is not a timely take-back program in your area that accepts medicines containing controlled substances, the most effective way to immediately and completely eliminate the potential for harm is to remove these medicines from the home by flushing them down the sink or the toilet.

To find out whether there are alternative disposal options for medicines containing controlled substances in your community, contact your city or county government.
Consumers can visit the DEA’s website for more information about drug disposal, National Prescription Drug Take-Back Day events and to locate a DEA-authorized collector in their area.
Consumers may also call the DEA Office of Diversion Control’s Registration Call Center at 1-800-882-9539 to find an authorized collector in their community, or talk to their pharmacist to see if he or she knows of other disposal programs in your area.​
​ FDA continues to work with and encourage the manufacturers of these products to develop alternative, safe disposal systems.

6: I live in an assisted living community and take my own medicines. I have prescription medicines that I no longer need. How can I safely dispose of them
Check first with your community’s health care management team to learn the best way to dispose of your used or unneeded medicines.
If you learn that you are responsible for disposal of your own medicines, there are a few options that you can choose from:

1. DEA-authorized collectors safely and securely collect and dispose of pharmaceutical controlled substances and other prescription drugs. A retail pharmacy or a hospital or clinic with an on-site pharmacy may install, manage and maintain a DEA-authorized medicine collection receptacle at your long-term care facility. You may also be able to use a DEA-authorized mail-back program, or a take-back program held by local law enforcement to safely dispose of your unused medicines.
2. If no DEA-authorized collector or medicine take-back program is available in your area, you can dispose of most medicines in your household trash. Mix the medicines (do NOT crush tablets or capsules) with an unpalatable substance such as dirt, kitty litter or used coffee grounds. Place the mixture in a container such as a zip-top or sealable plastic bag, and throw the container in your household trash. Before throwing out your empty pill bottle or other empty medicine packaging, remember to scratch out all personal information on the prescription label to make it unreadable.
3. A small number of medicines may be especially harmful, and in some cases even fatal in just one dose, if they are taken by someone other than the patient. For this reason, a few medicines have specific disposal instructions telling you to flush them down the sink or toilet when they are no longer needed and when they cannot be disposed of through a DEA-authorized collector. For example, you should flush strong pain medicines such as Oxycontin down the drain as soon as they are no longer needed. When you dispose of these medicines down the sink or toilet, they cannot be accidentally taken by children, pets, or anyone else. Here is the ​​list of medicines recommended for disposal by flushing​​.
4. Some of the medicines recommended for disposal by flushing are available as adhesive skin patches. For example, fentanyl patches are used to treat patients in constant pain by releasing a continuous amount of drug from the patch over three days. Even a used patch that has been worn for three days still contains enough fentanyl to harm or cause death in a child. FDA recommends disposing of used patches immediately after taking them off of the skin. Fold the patch in half so that the sticky sides meet, and then flush it down the toilet. Used or unneeded fentanyl patches should NOT be placed in the household trash where children or pets can find them.

Source: USA.gov

Get answers to common questions about buying and using medications.
What's on This Page

• Help with Prescription Drug Costs
• Buy Medicine Online
• Complaints about Medicine and Medical Products
• Dispose of Unused Medicines Safely
• Drug Labels and Identifying Medications
• Find the Generic Equivalent to a Brand Name Prescription Drug
• Imported Prescription Medicine for Personal Use

Help with Prescription Drug Costs
What help is available?

• State human service agencies and local health centers provide direct assistance to people in distress or with limited access to health care with assistance and referrals to other local organizations that may be able to help.
• Use Healthfinder.gov’s list of prescription assistance resources to find more programs that could help you pay for your medicines.
• You or your child may qualify for Medicaid or CHIP. Learn more about these programs.
• If you are eligible for Medicare, you can get help paying for your prescriptions through Medicare Part D.

Am I eligible?
The requirements for each program vary by state. Your state human services agency or your local health center will determine your eligibility.
How do I apply?
Your state human services agency or local health center will be able to help you with the application process.
Applications and requirements vary in states and cities.
How do I complain/where do I call for extra help?
If you need additional help finding the right program for you, or you want to make a complaint about a program, contact RXAssist.
Is there anything else I need to know?
Contact the pharmaceutical companies that make your prescription drugs or devices, and ask for any low-cost options, samples, or discounts,
Learn more about finding generic drugs to lower your cost.

Buy Medicine Online
If you’re busy or can’t physically get to a store, using an online pharmacy may be a good solution.
But before you do, review the website carefully. Some sites that offer prescription drugs or other medical products at low prices may be fraudulent.
Consider using only U.S. -based pharmacies licensed by a state’s board of pharmacy.
Health and Financial Risks of Fake Online Pharmacies
Buying medications from fake online pharmacies can be dangerous, or even deadly. It can also hurt your wallet.

• You could receive counterfeit or substandard drugs.
• Slight differences in your medicine can make a big difference and cause further health complications.
• You could put your personal and financial information at risk.

Warning Signs of Fake Online Pharmacies
Learn how to identify the warning signs of a fake online pharmacy. You should be suspicious if an online pharmacy:

• Allows you to buy medication without a prescription from your doctor
• Offers medications at deep discounts that seem too good to be true
• Is not licensed and has no physical address in the U.S.
• Sends unsolicited email (spam) offering cheap drugs
• Does not have a licensed pharmacist available to answer your questions

Services for Safely Buying Medicine Online
Use these tools to help you safely buy medicine over the internet:

• Learn from the BeSafeRx campaign about the dangers of buying medicine from fake online pharmacies, and safely buying medicine online.
• Search the FDA's database of safe online pharmacies.

Complaints about Medicine and Medical Products
The U.S. Food and Drug Administration (FDA) manages consumer complaints about medicines, dietary supplements, and medical devices.
If you or someone in your family had an adverse reaction to a medical product:

• Call 911 if you are experiencing an emergency
• Report an adverse reaction to a medication or other medical product:
• Fill out the FDA's MedWatch online reporting form.
• Call MedWatch at 1-800-FDA-1088 (1-800-332-1088).
• Download, print, and mail or take the voluntary reporting form to your doctor.

Pet Medication Problems
Some dogs or cats may have adverse reaction to medication or problems with a medical device.
You have several options:

• If your pet is in immediate danger, call your veterinarian.
• You can call the FDA’s Center for Veterinary Medicine at 1-888-FDA-VETS or 1888-332-8387
• Send an email to FDA's Center for Veterinary Medicine AskCVM@fda.hhs.gov
• Download electronic form 1932A (PDF), Download Adobe Reader, scan, and email back the completed form to CVM1932a@fda.hhs.gov

File a Complaint About an Online Pharmacy
If you suspect an online pharmacy is fake, report it to the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA).
Tracking Potentially Dangerous Medication
The FDA Adverse Event Reporting System (FAERS) database tracks information from reports about problems associated with medical products.
The FDA releases quarterly reports based on information from FAERS to help medical professionals and the public learn about potential safety issues with specific medical products.
Dietary Supplements
The FDA regulates dietary supplements such as vitamins and herbs as food products.

• Learn more about dietary supplements.
• Contact your local FDA Consumer Complaint Coordinator to file a complaint about dietary supplements.
• Consumers and health professionals can report an adverse health event related to a dietary supplement through the FDA Safety Reporting Portal.

Dispose of Unused Medicines Safely
Medicines can be harmful to you, your children, or pets if they're not used and disposed of properly.
Use these guidelines for disposing of unused medicines:

• Check out the FDA guide on how to safely dispose of unused medicine.
• Look for disposal instructions on the medicine's packaging.
• Ask your pharmacist how to dispose of unused medicine.
• Learn about your community's drug take back day and search for a nearby disposal location to bring your unused medicine for disposal.

Contact the FDA's toll free numbers (855) 543-3784, or (301) 796-3400 or email druginfo@fda.hhs.gov for more information.

Drug Labels and Identifying Medications
The Food and Drug Administration (FDA) regulates prescription drugs and over-the-counter (non-prescription) drug labeling.
Learn How to Read Drug Labels

• Learn the different parts of new over-the-counter drug labels.

Identify Your Medicine

• Search drug images at Pillbox to identify medicine that is out of its labeled container.

Find out about Your Medicine

Look up generic or brand name medications and find their directions, warnings, and side effects on DailyMed.

Find the Generic Equivalent to a Brand Name Prescription Drug
The difference between generic drugs and brand names (non-generic) is based on several factors:

• Pill size
• Pill color
• Inactive ingredients may vary from brand name

By FDA standards, generic drugs have met the same rigid standards as brand name drugs such as active ingredient, dosage form, and strength.
Generics often cost less than non-generic drugs because of the cost associated with bringing a new drug to the marketplace.
Developing a new brand name drug requires clinical trials, and advertising budgets to build awareness about a product.
Because generic medications are cheaper does not mean they are less effective.
Learn more about generic drugs.
Search For Drug Names
Use the Electronic Orange Book to find FDA-approved drugs and their generic equivalents. Search by active ingredient, proprietary (trade) name, applicant holder, or applicant number.
To find the generic match to your medication:

• Visit the Electronic Orange Book and search by the proprietary (trade) name. This determines the ingredients.
• Next, use the Ingredient Search for all approved products that contain the ingredient(s).

Email druginfo@cder.fda.gov if you have general questions about information in FDA's Electronic Orange Book.

Imported Prescription Medicine for Personal Use
In most cases, it is illegal to ship or mail a prescription medication to the U.S. for personal use because drugs in other countries have not been properly evaluated or approved by the FDA
Bringing Medication into the U.S.

• Get the facts about traveling to the U.S. with medications.
• You can generally only import FDA-approved prescription drugs.
• Contact the TSA if you have questions about medications in your luggage or carry-on when flying.
• Contact the FDA’s Division of Drug Information at 855-543-3784 (DRUG) or email at druginfo@fda.hhs.gov if you have questions about traveling with medications.

Bringing Your Medications into a Foreign Country
Before Your Trip

• Check the website of the U.S. Embassy or consulate located in the country you are traveling to, or contact them by phone to learn more about that foreign government’s policy.
• Check the website of the foreign country you will be visiting under the travelers or visitors section for guidance or restrictions on the importing of medication or medical devices for personal use.
• You can also contact the foreign country’s consulate located in the U.S. and closest to your state.

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3} Medicated To DEATH

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4} Mixing Breakfast and Medications: A Dangerous Cocktail

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5} Medication Safety Tips

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6} Shocking Drug Statistics

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7} From Pharmacist To Healthcare Hero

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8} The Economics Of Counterfeit Drugs

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9} Why Are Meds Cheaper In Canada?

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10} Education Before Medication

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11} From Dedication To Medication

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12} The Dog Ate My Meds

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13} Medications That Delete Your Nutrients

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14} Myths About Drug Abuse And Addiction

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15} Am I Addicted To My Medications?

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16} High Blood Pressure: Medications And You

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17} Adverse Effects Of Oxycodone Addiction

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18} Adverse Effects Of Oxycodone On The Brain

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19} What Can Be Prescribed Via Telemedicine

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20} America's Other Drug Problem

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21} ADHD Treatments For Preschoolers (ages 4-5)

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22} Drug Approval Process

Check your drugs knowledge, take this short (15 questions) true/false quiz. Get the answers and your score at the end of the quiz. Also each answer with informative explanation. 1. In most cases death from ecstasy is caused by the body overheating and dehydration. True False 2. Drinking black coffee does not help a person sober up. True False 3. Breathing in cannabis longer will result in more cannabis getting to the brain. True False 4. If a woman drinks the same amount of alcohol as a man it will have the same effect. True False 5. Cannabis skunk and weed is more potent (stronger) as cannabis grass and resin. True False 6. Sleep helps the body eliminate alcohol more quickly. JTrue False 7. Long term alcohol reduces both virility and fertility in men and women. True False 8. Katamine is a stimulate drug. True False 9. Half a pint of lager or one glass of wine equals one unit of alcohol. True False 10. A significant number of young people have unprotected sex whilst under the influence of alcohol. True False 11. Alcohol is a stimulate drug. True False 12. A pregnant woman who drinks is putting the health of her baby at risk. True False 13. Legal highs are legal because they are safe. True False 14. Mephedrone is a plant fertilizer. True False 15. The legal high NRG is the same drug no matter where you buy it from. True False Score = Correct answers:

Drugs Quiz Answers 1.True Ecstasy effects how the body regulates temperature and the user risks overheating if they do not drink enough fluid. Physical exercise, like dancing at clubs/raves, increases the body’s temperature. This causes sweating and the loss of body fluids. The body can overheat. It is recommended that a person should sip 1 pint of water every hour to prevent the risk of overheating and dehydration. It is also advisable to wear lose fitting clothing, take plenty of breaks from dancing so that you can cool down, and ideally take no more than one ecstasy tablet over the course of the evening. 2. True Black coffee has no influence on the rate at which the liver breaks down alcohol. 3. False Breathing in (inhaling) cannabis for a long time, before breathing out (exhaling) does not get the user more (stoned) intoxicated. Breathing in longer will increase the amount of tar and other dangerous chemicals that can cause lung problems/damage. 4. False Generally if men and women drink at the same level there is a greater health risk to women. Women’s bodies can’t process alcohol as well as men’s. Women tend to weigh less than men, have more body fat and less water to dilute the alcohol in the body so the alcohol stays in the system for longer. Women are also more vulnerable to alcohol related organ damage and start to have alcohol related problems at lower drinking levels than men do. 5. True Weight for weight, skunk weed has higher levels of tetrahydrocannabinol (THC) in it than the most common forms of cannabis – grass and resin. Therefore, regular, daily use increases the risks of psychological dependency problems. Some American research has reported that users have experienced physical withdrawal symptoms. As skunk weed is stronger, it increases the effects of cannabis, such as: memory loss; impaired judgement; mental health problems – paranoia, anxiety, and in some cases psychosis; accidents, and work performance. 6. False Sleep has no influence on the rate at which the liver breaks down alcohol. Alcohol does have an effect on the quality of sleep, however. Although we may seem to sleep well after alcohol, we have a reduced amount of dream sleep. Consequently we feel tired and unrested the next day. 7. True As Shakespeare said alcohol ‘provokes the desire, but takes away the performance’. It also reduces the level of the male sex hormone, testosterone, and can lead to a lowered sperm count, shrinkage of the penis and testicles, and loss of sexual hair. Heavy drinking in women can cause a reduction in sex hormones, shrinkage of breasts, ovaries and external genitalia, disrupted periods and loss of vaginal secretion. 8. False Ketamine is (a sedative) powerful general anaesthetic. It is short acting and it has been used for operating on humans and animals. Just like LSD, ketamine can cause perceptual changes as well reducing the effects of bodily sensation. Users have reported having 'out of the body' experiences. Taken in high doses, users can become physically incapable of moving while under the influence of the drug. Because of its anaesthetic qualities, people have been known to hurt themselves and not realise until the following day. Ketamine should not be taken with other drugs, particularly depressants, such as alcohol or diazepam (Valium). It can also cause high blood pressure, which can be particularly dangerous with drugs like ecstasy or amphetamines. Large doses could induce unconsciousness and you could die as result of respiratory failure. 9. False One unit is equal to 10 ml of pure alcohol. The alcohol content is expressed as the percentage of the bottle or can. Alcoholic drinks even if they appear the same, may have a different alcohol content. So depending on the volume you drink, the amount of alcohol content may differ significantly. So one small glass of wine can be anywhere between one and three units. 10. True According to the sexual health charity Brook, one in seven 16‐24 year olds had unprotected sex after drinking alcohol and one in five had sex that they regretted. Unprotected sex greatly increases the risk of sexually transmitted infections and unintended pregnancy. 11. False Alcohol is exactly the opposite, a depressant. You may be thinking “That can’t be true. I feel quite cheerful after a couple of beers”. This is because one of the first things to be depressed is our control over feelings, emotions and inhibitions. This is why alcohol is used so much to loosen people up at parties and for Dutch Courage. It is also why so many people do things when they have had a few drinks which they would not dream of doing when sober, and often regret it! 12. True Alcohol can damage a developing baby, particularly in the first three months of the pregnancy. During this early stage, the alcohol can interfere with organ development leading to abnormalities. Later in pregnancy the effects are mainly on growth. Heavy drinking can cause foetal alcohol syndrome, characterised by low birth weight, growth retardation, abnormal features, especially of the face and head, brain damage and behavioural and learning problems. 13. False Legal highs try to mimic the effects of illegal drugs through combining different legal chemicals. Websites often sell these chemical products with a warning that states 'not for human consumption’ – this way they by‐pass any problems with the law. However, the effects on humans of the chemicals used in these products are often untested or poorly researched, and as such can be very unsafe to use as a drug. Legal highs are as unsafe to use as any current illicit drug. 14. False When mephedrone was legal it was sold as plant fertiliser to bypass any legal constraints faced if sold as a recreational drug. Mephedrone is not a plant fertiliser and it's as unsafe as any current illicit drug. The unsafe status of mephedrone is increased due to little being known about its long term effects. 15. False Even though you can buy NRG as a legal high you cannot rely that manufacturers are using the same combinations of chemicals. This means that one batch of NRG can be very different to another, and as such each time it is purchased the risks of adverse affects are increased due to the likelihood of new and untested chemicals being added to the mix. In research studies of the same legal high being purchased from a number of websites, it was found that the chemicals used varied so much that they could not be classed as the same product. In short, you do not know what you are buying even though the name of the legal high is the same.

Generic Drugs: Questions & Answers Source: Food and Drug Administration (FDA)

1. What are generic drugs?
2. Do generic medicines work the same as brand-name medicines?
3. Why do brand-name medicines look different from their generic versions?
4. Why do generic medicines cost less than brand-name medicines?
5. What standards must generic medicines meet to receive FDA approval?
6. Is a generic version of my brand-name medicine available?
7. Does FDA monitor side effects or safety issues with generic medicines?
8. Where can I find more information about generic medicines?

Frequently Asked Questions about the FDA Drug Approval Process Source: Food and Drug Administration (FDA)

1. Why are drugs evaluated by the FDA?
2. Does FDA test drugs?
3. What are clinical trials and how do they relate to drug approval?
4. How long does the drug approval process take?
5. What are the different types of drug applications that can be submitted to FDA?
6. Do over-the-counter (OTC) medications go through the same approval process as prescription drugs?

Prescriptions: Questions and Answers Source: Drug Enforcement Administration (DEA)

1. What is a prescription?
2. What information is required on a prescription for a controlled substance?
3. Can controlled substance prescriptions be refilled?
4. Can controlled substance prescriptions for hospice patients be faxed to a pharmacy?
5. Is it appropriate to provide a DEA registration number on prescriptions written for medications other than controlled substances?
6. Is it permissible to dispense a prescription for a quantity less than the face amount prescribed resulting in a greater number of dispensations than the number of refills indicated on the prescription?
7. Can a practitioner prescribe methadone for the treatment of pain?
8. Can an individual return his/her controlled substance prescription medication to a pharmacy?

Over The Counter Medicines: Faq's Source: KnowyourOTCs.org

1. What is an over-the-counter (OTC) medicine?
2. What kinds of medicine can I purchase over the counter?
3. What will happen if I don't follow the dosage on over the counter (OTC) medication
4. What is a Drug Facts label?
5. What over-the-counter (OTC) medicines are safe during pregnancy?
6. How do I give medicines to my children safely?
7. Are expired over-the-counter (OTC) medicines safe?
8. How do I dispose of unwanted over the counter (OTC) drugs?

Misuseuse of Prescription Drugs: Vital Questions & Answers For Parents Source: New York Department of Health

1. What is prescription drug abuse?
2. How big a problem is prescription drug abuse?
3. At what age are teens abusing prescription medications?
4. What are some of the most commonly abused prescription drugs?
5. What about the abuse of over-the counter (OTC) medications that can be bought in a store or pharmacy without a prescription?
6. Do different age groups abuse different types of prescription medications?
7. What can I do to help prevent my child from misusing prescription medications?
8. How can I talk to my kids about pharmaceutical medication abuse?

Eight Questions From Teens About Drugs and Alcohol Source: National Institute on Drug Abuse For Teens

1. Why do some people become addicted, while others don’t?
2. What can cause a hangover?
3. What properties in drugs make them addicting?
4. Does marijuana use lead to the use of other drugs?
5. Is medical marijuana good for you?
6. Can drugs affect animals?
7. How can I help someone if they are on drugs?
8. Are video games more addictive than drugs?

Prescription Drug Abuse: CDC Answers Your Questions Source: PBS News Hour

1. Many states have prescription limits. Are doctors simply ignoring these? Or do they prescribe more doses per patient than is required for relief?
2. Do physicians make any money when a patient fills his or her prescription for narcotics? Do they have other incentives or fears that may cause them to over-prescribe opiates?
3. My son is addicted to opiates and is desperately seeking inpatient treatment. He was initially prescribed them for treatment of Piriformis Syndrome. He has no insurance and very little money, but we will find a way to pay for this treatment. He is currently living in North Carolina, but he is willing to go anywhere for treatment. We are all fully aware that his life is in danger. Is there somewhere you can direct me to find help for him? A place that effectively treats addiction as soon as possible?
4. Does CDC have data on the percentage of prescription overdose deaths that also had illegal drugs like marijuana in their system? Or alcohol? How do these substances interact with prescription drugs?
5. What is the correct way to dispose of prescription painkillers prescribed after surgery and no longer needed? I have heard some talk of putting them in coffee grounds and then putting them in the trash. Is that true? Is there a better method?
6. How many people who end up addicted obtain these drugs legally through prescriptions? Or do people get them from people who obtain the pills illegally, i.e., drug dealers?
7. My husband takes at least two Hydroco/Acetamin 10-325 (that is what it says on the label) every morning. He sometimes takes more during the day for pain. He had a car accident over 10 years ago and has pain from his injuries. When he takes a lot of the medication he acts goofy and slow. How do I know whether he is addicted or whether he really needs it for pain?
8. What sort of income patterns do you see among abusers and which are more likely to end up dead? I know that hydrocodone is being talked about a lot by the FDA for possible C2 classification. Does C2 classification significantly reduce abuse and death or does the damage just shift to a new drug?
9. I bet the real stats are much worse. They are only looking into a few pills, not all the new sleeping aids or ADHD meds, liver damage and suicide. They are looking at overdoses from a few of the big name downers … pills are a mess in this country. Are overdoses from other legal drugs — or in combination with some of the main opiates — being examined?
10. Is there fear in the medical community that hesitancy over prescribing prescription drugs on the part of some doctors will lead to more pain for those who truly need these drugs?

Questions and Answers About Investigational Drugs Source: Patient Advocate Foundation (PAF)

1. What is an investigational drug?
2. How do patients get investigational drugs?
3. Are there other ways to get investigational drugs?
4. Are all investigational drugs available through an expanded access or special exception mechanism?
5. What is the NCI's role in providing access to investigational drugs?
6. Who can provide access to investigational drugs being developed by pharmaceutical companies?
7. Are there specific criteria used to determine whether patients can receive an investigational drug outside the clinical trial setting?
8. What should patients do if they are interested in receiving an investigational drug through a special exception or expanded access mechanism?
9. What are the costs involved in receiving an investigational drug?
10. What are some of the potential drawbacks to receiving an investigational drug?
11. How can patients find out more information about a specific investigational drug?
12. What other resources are available on this topic?

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Generic Drugs: Questions & Answers

1. What are generic drugs?
   A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as its brand-name version. In other words, you can take a generic medicine as an equal substitute for its brand-name counterpart.
   
   Additional Resource:
   Generic Drug Facts
   At-a-glance information on generic medicines, including why they may look different and often cost less than brand-name medicines.
2. Do generic medicines work the same as brand-name medicines?
   Yes. Any generic medicine modeled after a brand-name medicine must perform the same in the body as the brand-name medicine. This standard applies to all generic medicines. A generic medicine is the same as a brand-name medicine in dosage, safety, effectiveness, strength, stability, and quality, as well as in the way it is taken and the way it should be used. Generic medicines use the same active ingredients as brand-name medicines and work the same way, so they have the same risks and benefits as the brand-name medicines. The FDA Generic Drugs Program conducts a rigorous review to make certain generic medicines meet these standards, in addition to conducting 3,500 inspections of manufacturing plants a year and monitoring drug safety after the generic medicine has been approved and brought to market.
   
   It is important to note that there will always be a slight, but not medically important, level of natural variability—just as there is for one batch of brand-name medicine compared with the next batch of brand-name product. This variability can and does occur during manufacturing, for both brand-name and generic medicines. When a medicine, generic or brand-name, is mass produced, very small variations in purity, size, strength, and other parameters are permitted. FDA limits how much variability is acceptable.
   
   For example, in a very large research study1 comparing generics with brand-name medicines, it was found that there were very small differences (approximately 3.5%) in absorption into the body between generic and the brand-name medicines. Some generics were absorbed slightly more, some slightly less. This amount of difference is expected and acceptable, whether for one batch of brand-name medicine tested against another batch of the same brand, or for a generic tested against a brand-name medicine. As a rule, the difference for the generic-to-brand comparison was about the same as the brand-to-brand comparison.
   
   Additional Resource:
   Research study: Clinical equivalence of generic and brand-name drugs used in cardiovascular disease
   A study of 38 published clinical trials showed no evidence that brand-name heart medicines worked any better than generic heart medicines.
3. Why do brand-name drugs look different from their generic versions?
   Trademark laws in the United States do not allow a generic drug or medicine to look exactly like other drugs already on the market. Generic medicines and brand-name medicines share the same active ingredient, but other characteristics, such as colors and flavorings, that do not affect the performance, safety, or effectiveness of the generic medicine, may be different.
   
   Additional Resource:
   The importance of the physical characteristics of generic drugs
   John R. Peters, M.D., Deputy Director of the Office of Generic Drugs, discusses the significance of size, shape, and other physical attributes of generic tablets and capsules on patient adherence and safety.
4. Why do generic medicines cost less than brand-name medicines?
   Generic drugs or medicines become available only after a rigorous review by FDA and after a set period of time that the brand-name version has been on the market exclusively. This is because new drugs, like other new products, are usually protected by patents that prohibit others from making and selling copies of the same drug. The patent protects the company's investment in the drug's development by giving the company the sole right to sell the drug while the patent is in effect. Because it takes such a long time to bring a new drug to market, this period of exclusivity allows drug companies to recoup the costs associated with bringing a new drug to market. FDA also grants certain periods of marketing exclusivity to brand-name drugs that can prohibit the approval of generic drugs. Once these patents and marketing exclusivities expire (or if the patents are successfully challenged by the generic drug company), the generic drug can be approved.
   
   Generic drugs also tend to cost less than their brand-name counterparts because generic drug applicants do not have to repeat animal and clinical (human) studies that were required of the brand-name medicines to demonstrate safety and effectiveness. This is why the application is called an “abbreviated new drug application.” This, together with competition between the brand-name drug and multiple generic drugs, is a large part of the reason generic medicines cost much less.
   
   In fact, multiple generic companies are often approved to market a single product; this creates competition in the marketplace, typically resulting in lower prices.
   The reduction in upfront research costs means that, although generic medicines have the same therapeutic effect as their branded counterparts, they are typically sold at substantial discounts, an estimated 80 to 85% less, compared with the price of the brand-name medicine. According to the IMS Health Institute, generic drugs saved the U.S. healthcare system $1.67 trillion from 2007 to 2016.
   
   Additional Resource:
   GenericCompetition and Drug Prices
   Generic competition is associated with lower drug prices, with the entry of the second generic competitor being associated with the largest price reduction.
5. What standards must generic medicines meet to receive FDA approval?
   Drug companies can submit an abbreviated new drug application (ANDA) for approval to market a generic drug that is the same as (or bioequivalent to) the brand-name version. FDA's Office of Generic Drugs reviews the application to make certain drug companies have demonstrated that the generic medicine can be substituted for the brand-name medicine that it copies.
   An ANDA must show the generic medicine is equivalent to the brand in the following ways:
   - The active ingredient is the same as that of the brand-name drug/innovator drug. - - An active ingredient in a medicine is the component that makes it pharmaceutically active — effective against the illness or condition it is treating.
   - - Generic drug companies must provide evidence that shows that their active ingredient is the same as that of the brand-name medicine they copy, and FDA must - review that evidence.
   - The generic medicine is the same strength.
   - The medicine is the same type of product (such as a tablet or an injectable).
   - The medicine has the same route of administration (such as oral or topical).
   - It has the same use indications.
   - The inactive ingredients of the medicine are acceptable.
   - - Some differences, which must be shown to have no effect on how the medicine functions, are allowed between the generic and the brand-name version.
   - - Generic drug companies must submit evidence that all the ingredients used in their products are acceptable, and FDA must review that evidence.
   - It lasts for at least the same amount of time.
   - - Most medicines break down, or deteriorate, over time.
   - - Generic drug companies must do months-long "stability tests" to show that their versions last for at least the same amount of time as the brand-name.
   - It is manufactured under the same strict standards as the brand-name medicine.
   - It meets the same batch requirements for identity, strength, purity, and quality.
   - The manufacturer is capable of making the medicine correctly and consistently.
   - Generic drug manufacturers must explain how they intend to manufacture the medicine and must provide evidence that each step of the manufacturing process will produce the same result each time. FDA scientists review those procedures, and FDA inspectors go to the generic drug manufacturer's facility to verify that the manufacturer is capable of making the medicine consistently and to check that the information the manufacturer has submitted to FDA is accurate.
   - Often, different companies are involved (such as one company manufacturing the active ingredient and another company manufacturing the finished medicine). Generic drug manufacturers must produce batches of the medicines they want to market and provide information about the manufacturing of those batches for FDA to review.
   - The container in which the medicine will be shipped and sold is appropriate.
   - The label is the same as the brand-name medicine's label.
   - - The drug information label for the generic medicine should be the same as the brand-name label. One exception is if the brand-name drug is approved for more than one use and that use is protected by patents or exclusivities. A generic medicine can omit the protected use from its labeling and only be approved for a use that is not protected by patents or exclusivities, so long as that removal does not take away information needed for safe use. Labels for generic medicines can also contain certain changes when the drug is manufactured by a different company, such as a different lot number or company name. Relevant patents or exclusivities are addressed.
   - - As an incentive to develop new medicines, drug companies are awarded patents and exclusivities that may delay FDA approval of applications for generic medicines. FDA must comply with the delays in approval that the patents and exclusivities impose.
   The ANDA process does not, however, require the drug applicant to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness.
   This allows generic medicines to be brought to market more quickly and at lower cost, allowing for increased access to medications by the public.
   
   Additional Resources:
   What Is the Approval Process for Generic Drugs?
   Detailed information on the critical factors the FDA reviews to make sure a generic medicine is as safe and effective as the brand-name version.
   The Generic Drug Approval Process, CDER Conversation
   An interview on how FDA reviews generic medicines with Ted Sherwood, Director, Office of Regulatory Operations, Office of Generic Drugs, Center for Drug Evaluation and Research.
   Generic Drugs Undergo Rigorous FDA Scrutiny
   A consumer article on FDA’s generic drug review process
6. Is a generic version of my brand-name medicine available?
   In addition to asking your local pharmacist for assistance, there are three ways to find out if there is a generic version of your brand-name medicine available:
   - Use Drugs@FDA, a catalog of FDA-approved drug products, including their drug labeling. - Search for generic equivalents by using the online version of the "Orange Book."
   - - First, search by proprietary or "brand" name.
   - - Second, search again by the active ingredient name.
   - - If other manufacturers are listed besides the brand-name manufacturer in result for searches by the "active ingredient," they are the generic product manufacturers.
   - - For very recent approvals, consult the First Generics List.
   
   If you are unable to locate a generic version of your brand-name medicine, it may be that the brand-name medicine is still within the period of time when it has exclusive rights to the marketplace, to allow drug companies to recoup their costs for the initial research and marketing of the brand-name or innovator drug.
   It is only after both patent and other periods of exclusivity are resolved that FDA can approve generic versions of the medicine.
7. Does FDA monitor side effects or safety issues with generic medicines?
   Yes. After FDA approves any medicine, including generics, it continues to examine the medicine's safety. FDA takes several actions to ensure safety and quality before and after a new or generic medicine is marketed.
   FDA staff continually monitors drug products to make certain the medicines at all levels of the supply chain, from active pharmaceutical ingredients (APIs) to products being sold to consumers, are safe, effective, and high quality.
   FDA also monitors and investigates reports of negative patient side effects or other reactions. The investigations may lead to changes in how a product (brand-name and generic counterparts) is used or manufactured.
   
   Due to limited resources, FDA is unable to perform independent clinical studies, and the agency lacks the regulatory authority to require the generic industry to conduct such studies. FDA will, however, continue to investigate these reports to ensure that it has all the facts about these possible treatment failures and will make recommendations to health care professionals and the public if the need arises.
   Currently, to better understand what may cause problems with certain formulations if, in fact, they are linked to specific generic products, FDA is encouraging the generic industry to investigate whether, and under what circumstances, such problems occur.
   
   Please visit our Drug Quality Sampling and Testing page to learn more about FDA's efforts to help ensure the regulatory standards for brand-name and generic medicines continue to be met throughout a product's lifecycle.
8. Where can I find more information about generic medicines?
   Contact your doctor, pharmacist, or other health care provider for information on generic medicines.
   For more information, you can also:
   - Visit the FDA Generic Drugs Program
   - Call 1-888-INFO-FDA

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Frequently Asked Questions about the Drug Approval Process

1. Why are drugs evaluated by the FDA?
   Drugs intended for human use are evaluated by FDA’s Center for Drug Evaluation and Research (CDER) to ensure that drugs marketed in the United States are safe and effective.
   Biological products are evaluated by FDA’s Center for Biologics Evaluation and Research.
2. Does FDA test drugs?
   No. It is the responsibility of the company seeking approval to market a drug to conduct laboratory and animal tests on the safety and effectiveness of a proposed new drug and then to submit that information to FDA for review by CDER physicians, statisticians, chemists, pharmacologists, and other scientist.
3. What are clinical trials and how do they relate to drug approval?
   Clinical trials are studies that use human subjects (people) to see whether a drug is effective and what side effects it may cause.
   The trials are for gathering information about a drug that has not yet been proven to treat patients with a specific condition. A drug being studied in a clinical trial is called an investigational drug.
   Clinical trials of drugs provide information about:
   - Whether the drug has the effect it is supposed to have.
   - How much of the drug to give to a patient and how often.
   - What side effects are associated with the drug and how they can best be managed.
   - How a drug is broken down in the body, and how long it stays in the body.
   - Which foods, drinks, or other drugs can be used at the same time or should be avoided.
   - Clinical trial results allow the FDA to make decisions about whether or not a drug should be approved for marketing.
   For more information, please see Clinical Trials: What Patients Need to Know.
4. How long does the drug approval process take?
   The 1992 Prescription Drug User Fee Act (PDUFA) established a two-tiered system – Standard Review and Priority Review.
   Standard Review is applied to a drug that offers at most, only minor improvement over existing marketed therapies. The 2002 amendments to PDUFA set a 10 month goal for a standard review.
   Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where none existed. The goal for completing a Priority Review is six months.
   For more information, please see PDUFA Performance Reports and Fast Track, Accelerated Approval and Priority Review.
5. What are the different types of drug applications that can be submitted to FDA?
   - Investigational New Drug (IND) -- Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines.
   - New Drug Application (NDA) -- When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for marketing approval, the sponsor submits a new drug application (NDA) to FDA. The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics.
   If the NDA is approved, the product may be marketed in the United States.
   - Abbreviated New Drug Application (ANDA) – An Abbreviated New Drug Application contains data that provides for the review and ultimate approval of a generic drug product.
   Generic drug applications are called "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, a generic drug applicant must scientifically demonstrate that its product is bioequivalent (performs in the same manner as the innovator drug).
   Once approved, an applicant may manufacture and market the generic drug product.
   - Biologic License Application (BLA) -- Biological products are approved for marketing under the provisions of the Public Health Service Act. The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the product.
   A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product.
   If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product.
6. Do over-the-counter (OTC) medications go through the same approval process as prescription drugs?
   No. Because there are over 300,000 marketed OTC drug products, instead of individual drug products, FDA reviews the active ingredients and the labeling of over 80 therapeutic classes of drugs, for example analgesics or antacids.
   For each class, an OTC drug monograph is developed and published in the Federal Register. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling.
   Once a final monograph is implemented, companies can make and market an OTC product without the need for FDA pre-approval. These monographs define the safety, effectiveness, and labeling of all marketing OTC active ingredients.
   New products that conform to a final monograph may be marketed without further FDA review. Those that do not conform must be reviewed by the New Drug Application process. A drug company may also petition to change a final monograph to include additional ingredients or to modify labeling.

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Prescriptions: Questions and Answers

1. What is a prescription?
   A prescription is an order for medication which is dispensed to or for an ultimate user. A prescription is not an order for medication which is dispensed for immediate administration to the ultimate user (e.g., an order to dispense a drug to an inpatient for immediate administration in a hospital is not a prescription).
   To be valid, a prescription for a controlled substance must be issued for a legitimate medical purpose by a registered practitioner acting in the usual course of sound professional practice.
2. What information is required on a prescription for a controlled substance?
   A prescription for a controlled substance must include the following information:
   • Date of issue;
   • Patient's name and address;
   • Practitioner's name, address, and DEA registration number;
   • Drug name;
   • Drug strength;
   • Dosage form;
   • Quantity prescribed;
   • Directions for use;
   • Number of refills (if any) authorized; and
   • Manual signature of prescriber.
   A prescription must be written in ink or indelible pencil or typewritten and must be manually signed by the practitioner.
   An individual may be designated by the practitioner to prepare the prescriptions for his/her signature.
   The practitioner is responsible for making sure that the prescription conforms in all essential respects to the law and regulation.
   
   Prescriptions for schedule II controlled substances must be written and be signed by the practitioner.
   In emergency situations, a prescription for a schedule II controlled substance may be telephoned to the pharmacy and the prescriber must follow up with a written prescription being sent to the pharmacy within seven days.
   Prescriptions for schedules III through V controlled substances may by written, oral or transmitted by fax.
3. Can controlled substance prescriptions be refilled?
   Prescriptions for schedule II controlled substances cannot be refilled. A new prescription must be issued.
   Prescriptions for schedules III and IV controlled substances may be refilled up to five times in six months.
   Prescriptions for schedule V controlled substances may be refilled as authorized by the practitioner.
4. Can controlled substance prescriptions for hospice patients be faxed to a pharmacy?
   A prescription written for a schedule II narcotic substance for a patient enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII or a hospice program which is licensed by the state may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile.
   
   A pharmacist may dispense directly a controlled substance listed in schedules III, IV, or V pursuant to either a written prescription signed by a practitioner or a facsimile of a written, signed prescription transmitted by the practitioner or the practitioner's agent to the pharmacy or pursuant to an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist.
5. Is it appropriate to provide a DEA registration number on prescriptions written for medications other than controlled substances?
   DEA strongly opposes the use of a DEA registration number for any purpose other than the one for which it was intended, to provide certification of DEA registration in transactions involving controlled substances.
   The use of DEA registration numbers as an identification number is not an appropriate use and could lead to a weakening of the registration system.
   Although DEA has repeatedly made its position known to industries such as insurance providers and pharmacy benefit managers, there is currently no legal basis for DEA to prevent or preclude companies from requiring or requesting a practitioner's DEA registration number.
   
   The Centers for Medicare and Medicaid Services has developed a National Provider Identification (NPI) number unique to each healthcare provider.
   The Final Rule for establishment of the NPI system was published in the Federal Register (FR 3434, Vol. 69, No. 15) by the Department of Health and Human Services on January 23, 2004.
   The effective date of this Final Rule was May 23, 2005; all covered entities were to begin using the NPI in standard transactions by May 23, 2007. A contingency extension was provided to covered entities unable to meet the 2007 deadline. Contingency plans were to not extend beyond May 23, 2008.
6. Is it permissible to dispense a prescription for a quantity less than the face amount prescribed resulting in a greater number of dispensations than the number of refills indicated on the prescription?
   Yes. Partial refills of schedules III and IV controlled substance prescriptions are permissible under federal regulations provided that each partial filling is dispensed and recorded in the same manner as a refilling (i.e., date refilled, amount dispensed, initials of dispensing pharmacist, etc.), the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and no dispensing occurs after six months past the date of issue.
7. Can a practitioner prescribe methadone for the treatment of pain?
   Federal law and regulations do not restrict the prescribing, dispensing, or administering of any schedule II, III, IV, or V narcotic medication, including methadone, for the treatment of pain, if such treatment is deemed medically necessary by a registered practitioner acting in the usual course of professional practice.
   
   Confusion often arises due to regulatory restrictions concerning the use of methadone for the maintenance or detoxification of opioid addicted individuals, in which case the practitioner is required to be registered with the DEA as a Narcotic Treatment Program (NTP).
8. Can an individual return his/her controlled substance prescription medication to a pharmacy?
   An individual may return his/her unused or unwanted controlled substance prescription medication to any retail pharmacy that is authorized by the DEA to collect unwanted pharmaceutical controlled substances.
   Search for an Authorized Collector Location. Alternately, if a pharmacy maintains mail-back packages, individuals may place unused or unwanted medications inside a mail-back package.
   Individuals may not give these unwanted medications to pharmacy employees, but must directly deposit the medications inside a collection receptacle at the pharmacy or inside a mail-back package provided by the pharmacy.
   
   A provision in the Code of Federal Regulations allows for an individual to return his/her unused controlled substance medication directly to a pharmacy in the event of a controlled substance being recalled or a dispensing error has occurred.
   An individual may dispose of his/her own controlled substance medication without approval from DEA. Medications should be disposed of in such a manner that does not allow for the controlled substances to be easily retrieved and that is consistent with applicable Federal, State, tribal, and local laws and regulations.
   In situations where an individual is deceased, any person lawfully entitled to dispose of the decedent’s property may dispose of controlled substances which were lawfully obtained by the deceased individual.

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Over The Counter Medicines: Faq's

1. What is an over-the-counter (OTC) medicine?
   Over-the-counter medicine is also known as OTC or nonprescription medicine.
   These terms refer to medicine that you can buy without a prescription.
2. What kinds of medicine can I purchase over the counter?
   OTCs can treat a wide variety of symptoms and ailments. Some OTCs provide temporary relief to pain, allergies, and minor cuts.
   Others treat recurring symptoms and conditions, like migraines or heartburn.
   Always match your symptoms to the OTC you are taking, and ask your healthcare provider or pharmacist if you have any questions.
3. What will happen if I don't follow the dosage on over the counter (OTC) medication?
   OTC dosage directions are instructions that should be followed exactly, unless a healthcare provider specifically tells you otherwise.
   This means you should never take more of a medicine than the label says, or for a longer period of time than the medicine label says.
   While OTCs are safe and effective when taken according to the label, no medicine is without risk, including OTCs.
   
   Always read and follow medicine labels to understand dosage strength and unique dosing directions for each OTC.
   Taking more than directed can lead to an overdose. Avoid taking multiple medicines that contain the same active ingredient, and never take a medicine for a longer period of time or in higher doses than the label recommends.
4. What is a Drug Facts label?
   The label for OTCs is called the Drug Facts label. This is the type of label using rule by the U.S. Food and Drug Administration (FDA) for the back and often the sides of the OTC box or package.
   It presents important information for the safe and effective use of an OTC in the same format and order for every medicine.
   Every OTC Drug Facts label on store shelves has been approved by FDA.
5. What over-the-counter (OTC) medicines are safe during pregnancy?
   Pregnancy is an exciting time and a great chance to take charge of your health.
   For many women, when you are pregnant or nursing you are more likely to pay more attention than ever to what goes into your body and you know that not all medicines are safe to take while pregnant or breastfeeding.
   
   Back pain and heartburn are two of the most common discomforts that come along with pregnancy, so be sure to discuss the products that can help you safely relieve those symptoms with your healthcare provider or pharmacist.
   The best thing you can do for your health and the health of your baby is to talk to your healthcare provider before taking any medicine when pregnant, breastfeeding, or when planning to become pregnant.
   
   Your healthcare provider can provide the best information about whether an over-the-counter (OTC) medicine may be right for you, but always keep the following tips in mind:
   • Discuss taking any medicines during your pregnancy with your healthcare provider.
   • Do not take certain pain relievers during the last three months of your pregnancy, since they may cause problems in your unborn child or complications during delivery.
   • When breastfeeding, always ask your healthcare provider before taking any medication.
   • If your healthcare provider recommends you take medication while breastfeeding, time it so that you can take the medicine after nursing or before your baby’s longest nap.
   
6. How do I give medicines to my children safely?
   When giving medicine to children, it is important to only use a product that treats your child’s specific symptoms.
   Do not give a medicine only intended for adults to a child. When possible, dose by your child’s weight following the instructions on the label.
   Always give the recommended dose and use the correct measuring device. And remember; keep all medicines and vitamins out of your child’s reach and sight.
   Ask your healthcare provider if you have any questions.
7. Are expired over-the-counter (OTC) medicines safe?
   Just like the dosing instructions and additional information on the label, the expiration date on the packaging is there for a reason.
   Once a medicine has reached its expiration date, it may not provide the treatment that you need.
   To ensure the medicines you take are both safe and effective, keep an eye on the expiration dates and safely dispose of any expired or unwanted medicines.
8. How do I dispose of unwanted over the counter (OTC) drugs?
   Follow these simple steps from the U.S. Food and Drug Administration (FDA) to dispose of OTCs in your household trash:
   • Mix medicines (do not crush tablets or capsules) with an unpalatable substance such as kitty litter or used coffee grounds.
   • Place the mixture in a container such as a sealed plastic bag.
   • Throw the container in your household trash.

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Misuse of Prescription Drugs: Vital Questions and Answers for Parents

1. What is prescription drug abuse?
   Prescription drug abuse is the use of prescription medication in a manner that is not prescribed by a health care practitioner.
   This includes using someone else's prescription or using your own prescription in a way not directed by your doctor.
2. How big a problem is prescription drug abuse?
   Most people take prescription medication responsibly under a doctor's care. However, there has been a steady increase in the non-medical use of these medications, especially by teenagers.
   Prescription drug abuse knows no boundaries; it occurs in all social, economic, geographic, and ethnic groups.
3. At what age are teens abusing prescription medications?
   Kids as young as 12 are trying prescription drugs to get high. Prescription drugs are often more easily available to children than illicit drugs like marijuana because they can be stolen from the medicine cabinet at home, rather than having to be bought on the streets.
   An added danger of abusing prescription drugs is that teens consider them safer than street drugs because they are manufactured by a pharmaceutical company.
4. What are some of the most commonly abused prescription drugs?
   Although any prescription drug can be abused, the three types of drugs that are most commonly abused are:
   • Painkillers, also known as narcotic or opiates/opioids. Examples include morphine, codeine, oxycodone (OxyContin), hydrocodone (Vicodin, Lortab) and meperidine (Demerol).
     A large single dose can cause severe respiratory depression and death. Long-term abuse leads to physical dependence and, in some cases, addiction.
   • Depressants, which are prescribed to treat anxiety and sleep disorders. Examples are pentobarbital sodium (Nembutal), diazepam (Valium), and alprazolam (Xanax).
     They slow down normal brain function and can cause a drowsy, uncoordinated feeling.
     Large doses can depress breathing and cause a coma. Long-term abuse can lead to physical dependence and addiction.
   • Stimulants are often prescribed to treat attention-deficit hyperactivity disorder (ADHD). Examples include methylphenidate (Ritalin), dextroamphetamine (Dexedrine)and amphetamine/dextroamphetamine (Concerta, Adderall).
     These drugs elevate blood pressure and heart rate. High doses can cause dangerously high body temperature and cardiac arrest brought on by an abnormal heartbeat.
   
5. What about the abuse of over-the counter (OTC) medications that can be bought in a store or pharmacy without a prescription?
   OTC drugs are also abused by teens. Some OTC products used medically to treat allergies and colds contain drugs that can cause serious harm if abused in large doses for non-medical purposes.
   Cough syrups can be equally dangerous when teens drink them to get high.
6. Do different age groups abuse different types of prescription medications?
   Yes. Painkillers are most commonly abused by teens, especially by younger teens. Stimulant abuse is more common among older teens and college students.
   Combining prescription drugs with alcohol makes them even more dangerous. Consumption of alcohol dramatically increases a person's potential for adverse reaction to pharmaceutical drugs.
7. What can I do to help prevent my child from misusing prescription medications?
   Three important things can be done to prevent your child from misusing prescription medication: Educate, Communicate and Safeguard.
   • EDUCATE yourself about medications that kids are abusing. Share this information with others who are in contact with your children – school administrators, coaches, counselors.
   • COMMUNICATE with your kids. Discuss the subject with your teenagers. See what your kids know about peers using medications without doctors' orders.
     Preliminary research shows teens believe experimenting with medications are safer than street drugs. Abuse of medications can be lethal.
     Set clear expectations with your teenagers, letting them know that under no circumstances should they ever take medications without your knowledge.
   • SAFEGUARD medications at home and other places. Ask your health care provider if any medications prescribed for your family have a potential for abuse.
     Take an inventory of prescription and OTC medications in your home. Pay attention to quantities. Keep medications out of reach and out of easily accessible places like the medicine cabinet.
     If your child needs medications during school hours, speak with school officials about policies for distributing medications to students. If possible, personally take the medications to the school nurse.
     Make sure unused medications are returned to you.
   
8. How can I talk to my kids about pharmaceutical medication abuse?
   Starting a conversation about drugs with your kids is never easy, but it's not as difficult as you may think. Take advantage of everyday opportunities and in no time at all, you'll have developed an ongoing dialogue with your child.
   Teachable moments are about using everyday events in your life to point out things you'd like your child to know about.
   When you talk to your kids about drugs, make a special point to tell them how dangerous prescription medication abuse is.

Get Serious NOW About Discussing the Abuse of Prescription Medications with Your Children. Let Them Know:

• Pharmaceuticals taken without a prescription or a doctor's supervision can be just as dangerous as taking illicit drugs or binge drinking.
• Abusing narcotic painkillers is just like abusing heroin. Both are capable of causing serious harm. Prescription medications are powerful substances.
• People taking medication under a doctor's care can benefit; however prescription medications can have unpredictable and potentially harmful effects on people who abuse them to get high.

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Eight Questions From Teens About Drugs and Alcolol

1. Why do some people become addicted, while others don’t?
   Great question, and a hard one. We don’t fully understand yet why this is so. We know that genes play a part, because an inclination for addiction can run in families, and because different strains of mice, rats, and other animals differ in how readily they develop addiction-like behaviors after they’re exposed to drugs.
   We also know that a person’s environment plays a part in addiction. For example, what are the factors that encourage someone who has tried a drug to keep on taking it to the point where they can’t stop?
   Many scientists are trying to untangle the answers so that we can find better ways to prevent and treat addiction. See these videos on how anyone can become addicted, and why drugs are so hard to quit.
   
   Update: Read more on what increases the risk of having a drug problem.
2. What can cause a hangover?
   There are several reasons why people experience hangovers from drinking. One component is dehydration. Alcohol causes the body to get rid of too much fluid, and the dehydration that results can cause headaches, nausea, thirst, and other symptoms of hangovers.
   While some people think that alcohol helps a person sleep, it actually disrupts sleep, and that can contribute to the grogginess that accompanies hangovers.
3. What properties in drugs make them addicting?
   Different drugs act on the brain in different ways, but they all cause release of the neurotransmitter dopamine in the brain’s reward area, which is what causes the pleasurable sensation (the high).
   Once a person uses a drug repeatedly, their brain starts to adjust to these surges of dopamine; the brain cells (neurons) make fewer dopamine receptors, or they simply produce less dopamine.
   The result is a lower amount of “dopamine signaling” in the reward area—it’s like “turning down the volume” on the reward signal. Then the person may start to find natural “rewards”—like food, relationships, or sex—less pleasurable; that’s one of the signs of addiction.
   Also, reduced dopamine signaling in the brain’s prefrontal cortex, which governs our ability to inhibit (slow down or stop) our impulses, makes it harder to resist the urge to take drugs even if a person would like to quit.
   Learn more about how drugs affect your brain and body.
4. Does marijuana use lead to the use of other drugs?
   The “gateway drug” concept—where using one drug leads a person to use other drugs— generates a lot of controversy. Researchers haven’t found a definite answer yet, but as of today the research does suggest that, while most people who smoke marijuana do not go on to use other drugs, most teens who do use other illegal drugs try marijuana first.
   For example, the risk of using cocaine is much greater for those who have tried marijuana than for those who have never tried it. However, this risk is also greater for people who have used alcohol and tobacco.
   Animal studies suggest that because the teen brain is still developing, using marijuana, alcohol, or tobacco in your teen years (or earlier) may alter your brain’s reward system (see the answer to #3 above), and that may put teens at higher risk of using other drugs.
   In addition, using marijuana puts children and teens in contact with people who use and sell other drugs, increasing the risk of additional drug use.
5. Is medical marijuana good for you?
   The marijuana plant has not been approved by the FDA for the treatment of any medical condition. A pill form of THC (the main chemical in marijuana that affects the brain) is already available for certain conditions, such as nausea associated with cancer chemotherapy and weight loss in patients with AIDS.
   Early research suggests that some of the active ingredients in marijuana, like THC and cannabidiol (CBD), might be able to help treat conditions and diseases like epilepsy, cancer, or addiction.
   Scientists are studying THC and CBD to try to develop new medications. However, smoked marijuana is unlikely to be an ideal medication because of its negative health effects, including the risk of addiction and the damage that smoking can do to your lungs.
6. Can drugs affect animals?
   Yes. Chemicals can have different effects in different animals—for instance, chocolate is delicious to humans and poisonous to dogs—so even small amounts of a drug could be very harmful for your pet.
   Alcohol can cause a dog to suffer dangerous drops in blood pressure, blood sugar, and body temperature, to have seizures, and to stop breathing. In dogs and cats poisoned by marijuana, signs may be seen within 3 hours, such as a lack of energy, low heart rate, low blood pressure, respiratory depression, hyperactivity, seizures, vomiting, and coma.
   Also, your pet wouldn’t understand that it had been given a drug, and the sensations that might feel like a “high” to a human would be a very scary experience for an animal.
7. How can I help someone if they are on drugs?
   One of the best things you can do for a friend with a serious drug problem is let them know you are there to support them. Tell them you’re concerned about their drug use and encourage them to seek help from a trusted adult; maybe a teacher, coach, parent, or counselor can help.
   You can also help by being a strong positive influence; help them get involved in non-drug-using activities like joining a club, playing music, or playing a sport. However, if your friend is becoming a negative influence in your life, you might have to step away from the friendship for a while.
   If you feel your friend is a danger to himself or herself, or to others, it is important to tell a trusted adult right away; it could save your friend’s life.
   See NIDA’s “Step by Step Guide” for teens and young adults.
8. Are video games more addictive than drugs?
   No, they aren’t more addictive—for example, they don’t cause painful physical withdrawal when you stop.
   Technically, video games wouldn’t be considered addictive. But they do act on some of the same systems in the brain as addictive drugs.
   For instance, they produce bursts of dopamine (described in answer #3 above), and some people think that playing video games a lot might cause problems similar to drug use, such as being unable to get satisfaction from other things in life.

---

Prescription Drug Abuse: CDC Answers Your Questions

1. Many states have prescription limits. Are doctors simply ignoring these? Or do they prescribe more doses per patient than is required for relief?
   Thirty-five states had some kind of prescription limit laws by August 2010. However, most such laws are restricted to certain schedules of drugs, to emergency prescriptions or to members of certain benefit plans (such as Medicaid).
   Very few states have laws requiring specific steps when exceeding daily dosage limits for all prescription painkillers (also called opioid pain relievers).
   The existing limits do not place major constraints on prescribing.
2. Do physicians make any money when a patient fills his or her prescription for narcotics? Do they have other incentives or fears that may cause them to over-prescribe opiates?
   No, physicians do not receive a fee when a patient fills an opioid prescription unless that physician is also authorized to dispense those drugs.
   They might charge an extra fee in that case, just as a pharmacy does. But only a small minority of prescribing physicians also dispense medications.
   It’s also important to examine other potential incentives for prescribing decisions, like insurance coverage of certain drugs or inadequate coverage for physical or behavioral therapy.
3. My son is addicted to opiates and is desperately seeking inpatient treatment. He was initially prescribed them for treatment of Piriformis Syndrome.
   He has no insurance and very little money, but we will find a way to pay for this treatment. He is currently living in North Carolina, but he is willing to go anywhere for treatment. We are all fully aware that his life is in danger.
   Is there somewhere you can direct me to find help for him? A place that effectively treats addiction as soon as possible?
   We do not recommend specific facilities. It would be best to contact a service that helps find treatment resources.
   The Substance Abuse and Mental Health Services Administration provides such a source.
   You can reach their treatment referral line by phone at: 800-662-HELP. You can also click on the “Treatment Locater” link at: http://www.samhsa.gov.
4. Does CDC have data on the percentage of prescription overdose deaths that also had illegal drugs like marijuana in their system? Or alcohol? How do these substances interact with prescription drugs?
   In 2010, marijuana was involved in less than 1 percent of prescription painkiller overdose deaths. Illegal drug involvement is much lower than other prescription drugs, like benzodiazepines (anti-anxiety medications like alprazolam [Xanax] or lorazepam [Ativan]).
   Benzodiazepines are recorded as contributing causes in 30 percent of prescription painkiller overdose deaths.
   Alcohol is recorded as a contributing cause in about 20 percent of prescription painkiller overdose deaths. Alcohol is also a depressant to the central nervous system.
   So the combined effect of alcohol and prescription painkillers can cause breathing to slow down so much that it stops.
5. What is the correct way to dispose of prescription painkillers prescribed after surgery and no longer needed? I have heard some talk of putting them in coffee grounds and then putting them in the trash. Is that true? Is there a better method?
   FDA has published guidelines on disposing of unused medicines — including steps for home disposal and information on drug take-back programs — which can be found here.
6. How many people who end up addicted obtain these drugs legally through prescriptions? Or do people get them from people who obtain the pills illegally, i.e., drug dealers?
   We know from national surveys, that most people (about 60 percent) who report using prescription painkillers non-medically (without a prescription or for the feeling they cause) obtain them from family or friends.
   More than one in six people (17 percent) who report using prescription painkillers non-medically said that they got the drugs they most recently used through a prescription from one doctor.
   
   The more often people use such drugs non-medically, the more likely they are to turn to other sources such as drug dealers. We also know that a large number of people who die of prescription painkiller overdoses obtain their drugs without a prescription.
   It is difficult to estimate these numbers exactly because the source information is often not available or not accurate.
   We do know that women are more likely to start with a prescription and then move to nonmedical use than are men.
7. My husband takes at least two Hydroco/Acetamin 10-325 (that is what it says on the label) every morning. He sometimes takes more during the day for pain. He had a car accident over 10 years ago and has pain from his injuries.
   When he takes a lot of the medication he acts goofy and slow. How do I know whether he is addicted or whether he really needs it for pain?
   We can’t provide medical advice in individual cases. To ensure proper medical care, patients should discuss any and all drug use — including prescription and over-the-counter medications — with their doctors.
   You can find information about specific drugs, including their side effects, here.
   
   Addiction can be defined using the ABCDE mnemonic as:
   • A) Inability to consistently Abstain;
   • B) Impairment in Behavioral control;
   • C) Craving; or increased “hunger” for drugs or rewarding experiences;
   • D) Diminished recognition of significant problems with one’s behaviors and interpersonal relationships; and
   • E) A dysfunctional Emotional response.
   
8. What sort of income patterns do you see among abusers and which are more likely to end up dead? I know that hydrocodone is being talked about a lot by the FDA for possible C2 classification.
   Does C2 classification significantly reduce abuse and death or does the damage just shift to a new drug?
   Prescription painkiller overdose deaths are more likely among people with lower education and income levels, people on Medicaid and the unemployed.
   It is difficult to predict what the effects of C2 classification of hydrocodone would be.
9. I bet the real stats are much worse. They are only looking into a few pills, not all the new sleeping aids or ADHD meds, liver damage and suicide.
   They are looking at overdoses from a few of the big name downers … pills are a mess in this country. Are overdoses from other legal drugs — or in combination with some of the main opiates — being examined?
   Yes, the CDC is looking at other types of pharmaceuticals. A recent CDC report published in the Feb 20, 2013, issue of the Journal of American Medical Association, for example, shows the number of overdose deaths involving 21 different types of pharmaceuticals.
   In particular, it shows the high involvement in overdose deaths of drugs prescribed for mental health conditions such as benzodiazepines, antidepressants and antipsychotics.
10. Is there fear in the medical community that hesitancy over prescribing prescription drugs on the part of some doctors will lead to more pain for those who truly need these drugs?
    The appropriate management of pain, including the use of prescription painkillers when necessary, remains a national goal. To date, there is no evidence that the legitimate use of prescription painkillers in the United States is declining as a result of attention to the overdose problem.
    Doctors should take precautions such as screening, urine drug tests and checking prescription drug monitoring programs before initiating prescriptions painkiller treatment in a patient and when deciding whether to continue their use.
    Prescription painkillers are powerful, addictive drugs, and should only be taken if necessary.

---

Questions and Answers About Investigational Drugs

1. What is an investigational drug?
   An investigational drug is one that is under study but does not yet have permission from the U.S. Food and Drug Administration (FDA) to be legally marketed and sold in the United States.
   FDA approval is the final step in the process of drug development. The first step in the process is for the new drug to be tested in the laboratory.
   If the results are promising, the drug company or sponsor must apply for FDA approval to test the drug in people. This is called an Investigational New Drug (IND) Application.
   Once the IND is approved, clinical trials can begin. Clinical trials are research studies to determine the safety and measure the effectiveness of the drug in people. Once clinical trials are completed, the sponsor submits the study results in a New Drug Application (NDA) or Biologics License Application (BLA) to the FDA.
   This application is carefully reviewed and, if the drug is found to be reasonably safe and effective, it is approved.
2. How do patients get investigational drugs?
   By far, the most common way that patients get investigational drugs is by participating in a clinical trial sponsored under an IND.
   A patient's doctor may suggest participation in a clinical trial as one treatment option.
   Or a patient or family member can ask the doctor about clinical trials or new drugs available for cancer treatment.
   
   Another way of learning about new drugs being tested in clinical trials is through the National Cancer Institute's (NCI) PDQ database. This database contains information on a large number of ongoing studies.
   Individuals can receive guidance on using this database via NCI's Cancer Trials Web site or they can call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).
   Information specialists there can search the database and provide a list of trials for individuals to share with their doctor.
3. Are there other ways to get investigational drugs?
   Less common ways that patients can receive investigational drugs are through an expanded access protocol or by a mechanism known as a special or compassionate exception.
   • Expanded Access◦Expanded access protocols are available for a limited number of investigational drugs that have been well studied and are awaiting final FDA approval for marketing. Expanded access allows a wider group of people to be treated with the drug.
     The purpose of an expanded access program is to make investigational drugs that have significant activity against specific cancers available to patients before the FDA approval process has been completed.
   • The drug company or IND sponsor must apply to the FDA to make the drug available through an expanded access program. There must be enough evidence from studies already completed to show that the drug may be effective to treat a specific type of cancer and that it does not have unreasonable risks.
     The FDA generally approves expanded access only if there are no other satisfactory treatments available for the disease.
   • Special Exception/Compassionate Exemption◦Patients who do not meet the eligibility criteria for a clinical trial of an investigational drug may be eligible to receive the drug under a mechanism known as a special exception or a compassionate exemption to the policy of administering investigational drugs only in a clinical trial.
     The patient's doctor contacts the sponsor of the investigational agent and provides the patient's medical information and treatment history; requests are evaluated on a case-by-case basis. The FDA must approve each request to provide the drug outside a clinical trial.
     There should be reasonable expectation that the drug will prolong survival or improve quality of life.
   These are some questions that are considered when determining if a patient may be a candidate to receive an investigational drug as a special exception:
   • Is the patient ineligible for a clinical trial?
   • Have standard therapies been exhausted?
   • Is there objective evidence that the investigational agent is active in the disease for which the request is being made?
   • Can the drug potentially benefit the patient?
   • What is the risk to the patient?
   In some cases, even patients who qualify for treatment with an investigational drug on a "compassionate basis" might not be able to obtain it if the drug is in limited quantity and high demand.
4. Are all investigational drugs available through an expanded access or special exception mechanism?
   No. The drug company or sponsor decides whether to provide an investigational drug outside the clinical trials setting.
   Availability may be limited in part by drug supply, patient demand, or other factors.
5. What is the NCI's role in providing access to investigational drugs?
   The NCI acts as the sponsor for many, but not all, investigational drugs. When acting as sponsor, the NCI provides the investigational drug to the physicians who are participating in clinical trials of the drug.
   A physician who wishes to treat a patient with the investigational drug as a special exception must request the drug from the NCI.
   The request must include the patient's age, sex, diagnosis, date of diagnosis, previous cancer therapy, current clinical status, intended dose and schedule of the requested drug, any proposed concomitant cancer drugs or other therapies, and pertinent laboratory data.
   These requests are reviewed on a case-by-case basis.
6. Who can provide access to investigational drugs being developed by pharmaceutical companies?
   In the case of investigational drugs sponsored by a drug company, the drug company in collaboration with the FDA provides access to the drug. The process is similar to that described above.
   A request to treat a patient with an investigational drug outside a clinical trial must be made to the drug company and to the FDA. The request to the FDA is sent as general correspondence to the appropriate reviewing division where the IND application is filed.
   The drug company can provide the name of the appropriate reviewing division. (FDA reviewing divisions are prohibited from divulging proprietary information such as whether a sponsor has filed an IND or the status of an IND.)
7. Are there specific criteria used to determine whether patients can receive an investigational drug outside the clinical trial setting?
   Generally, patients must meet the following criteria to be considered for treatment with an investigational drug outside the clinical trial setting; they must:
   • have undergone standard treatment that has not been successful;
   • be ineligible for any ongoing clinical trials; and
   • have a cancer diagnosis for which an investigational drug has demonstrated activity and is being studied in ongoing Phase 2 or Phase 3 protocols. The potential benefits of receiving the drug should outweigh the risks involved.
   
8. What should patients do if they are interested in receiving an investigational drug through a special exception or expanded access mechanism?
   Patients interested in gaining access to investigational drugs should talk to their physician about available options. Physicians can make requests for special exceptions by contacting the study sponsor.
   Physicians will be required to follow strict guidelines, including gaining approval from their Institutional Review Board and obtaining "informed consent" from the patient.
   Informed consent is a process that includes a document to be signed by the patient that outlines the known risks and benefits of the treatment, as well as the rights and responsibilities of the patient.
9. What are the costs involved in receiving an investigational drug?
   In general, the drug is provided free of charge. However, there may be other costs associated with the treatment.
   Patients should check with their insurer about coverage of these costs prior to beginning treatment.
10. What are some of the potential drawbacks to receiving an investigational drug?
    There are some potential drawbacks to receiving an investigational drug. It is not known whether an investigational drug is better than standard therapy for treating a disease, and a patient who is receiving an investigational drug may not receive any benefit from it.
    Side effects (both long-term and short-term) from the drug may not be fully understood, especially if the drug is in early phases of testing.
    Finally, a patient's health insurance company may not pay expenses associated with receiving the investigational drug.
11. How can patients find out more information about a specific investigational drug?
    Patients can find out more about a specific drug by contacting the drug company that is developing the drug.
    Information may also be available from the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).
12. What other resources are available on this topic?
    The following list of resources may be helpful:
    • NCI's cancerTrials Web site has a feature titled Understanding the Approval Process for New Cancer Drugs
      .
    • FDA's Center for Drug Evaluation and Research website features Oncology Tools, which contains a variety of information related to cancer including a section on access to unapproved drugs.
    • CTEP (the Cancer Therapy Evaluation Program at NCI) has information on Developing Cancer Therapies.
    

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