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Frequently Asked Questions


What are generic drugs?

Are generic drugs as safe as brand-name drugs?

Are generic drugs as strong as brand-name drugs?

Do generic drugs take longer to work in the body?

Why are generic drugs less expensive?

Are brand-name drugs made in more modern facilities than generic drugs?

Why do brand-name drugs and generic drugs look different?

Does every brand-name drug have a generic counterpart?

What is the best source of information about generic drugs?

What medications may I carry with me on an airline flight?

Our local church group is planning to go on a medical mission to Central America.
Can I take outdated drugs and samples on that trip?


Where can I find medication safety information?

Do prescription orders or prescription documents have an expiration date?

Can patients get their prescriptions from a physician's office free through the patient assistance programs sponsored by manufacturers?

Why can't I find pseudoephedrine products on the shelf of my pharmacy?

How long must prescription records be kept in North Carolina?

May I purchase Quinine Sulfate?

















What are generic drugs?



Answer:


A generic drug is a copy that is the same as a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and intended use.

























Are generic drugs as safe as brand-name drugs?



Answer:


Yes. FDA requires that all drugs be safe and effective. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their brand-name counterparts.

























Are generic drugs as strong as brand-name drugs?



Answer:


Yes. FDA requires generic drugs to have the same quality, strength, purity and stability as brand-name drugs.

























Do generic drugs take longer to work in the body?



Answer:


No. Generic drugs work in the same way and in the same amount of time as brand-name drugs.

























Why are generic drugs less expensive?



Answer:


Generic drugs are less expensive because generic manufacturers don't have the investment costs of the developer of a new drug. New drugs are developed under patent protection. The patent protects the investment—including research, development, marketing, and promotion—by giving the company the sole right to sell the drug while it is in effect. As patents near expiration, manufacturers
can apply to the FDA to sell generic versions. Because those manufacturers don't have the same development costs, they can sell their product at substantial discounts. Also, once generic drugs are approved, there is greater competition, which keeps the price down. Today, almost half of all prescriptions are filled with generic drugs.

























Are brand-name drugs made in more modern facilities than generic drugs?



Answer:


No. Both brand-name and generic drug facilities must meet the same standards of good manufacturing practices. FDA won't permit drugs to be made in substandard facilities. FDA conducts about 3,500 inspections a year to ensure standards are met. Generic firms have facilities comparable to those of brand-name firms. In fact, brand-name firms are linked to an estimated 50 percent of generic drug production. They frequently make copies of their own or other brand-name drugs but sell them without the brand name.

























Why do brand-name drugs and generic drugs look different?



Answer:


In the United States, trademark laws do not allow a generic drug to look exactly like the brand-name drug. However, a generic drug must duplicate the active ingredient. Colors, flavors, and certain other inactive ingredients may be different.

























Does every brand-name drug have a generic counterpart?



Answer:


No. Brand-name drugs are generally given patent protection for 20 years from the date of submission of the patent. This provides protection for the innovator who laid out the initial costs (including research, development, and marketing expenses) to develop the new drug. However, when the patent expires, other drug companies can introduce competitive generic versions, but only after they have been thoroughly tested by the manufacturer and approved by the FDA.

























What is the best source of information about generic drugs?



Answer:


Contact your physician, pharmacist, or insurance company for information on your generic drugs. You can also visit the FDA website at http://www.fda.gov/cder/ogd/index.htm for more information.

























What medications may I carry with me on an airline flight?



Answer:

Recent changes in Transportation Safety Administration rules governing carry-on items have left many consumers confused about what medication items they may take with them on commercial flights.

























Our local church group is planning to go on a medical mission to Central America.
Can I take outdated drugs and samples on that trip?



Answer:

Federal rules prohibit the use of outdated drugs in this way. Samples are also not intended for this purpose but may be used if complete treatments can be provided. Boxes of assorted samples of medications should not be left as donations.

A better solution to your problem is to contact MAP International (Medical Assistance Programs) This is a nonprofit, Christian relief and development organization based in Brunswick, Georgia. MAP can provide in-date and appropriate medicines for this purpose at a reasonable cost through their "Medicines for Missions" program. You can receive their guidelines and an application through their website at www.map.org or by calling Lisa Crosby at 800/225-8550.


























Where can I find medication safety information?



Answer:


Patients and health care professionals can now go to a single page on the Food and Drug Administration (FDA) Web site to find a wide variety of safety information about prescription medications. The Web page provides links to information on drug labeling; drugs that have a Risk Evaluation and Mitigation Strategy to ensure that their benefits outweigh their risks; post-market studies of drugs’ safety, efficacy, or optimal use; clinical trials; drug-specific safety information; warning letters; and consumer articles. Establishing such a Web page is one of the requirements of the Food and Drug Administration Amendments Act of 2007 and is among FDA's efforts to address the safe use of medications throughout their lifecycle. FDA recently launched another Web page that provides information on risks involved in using unapproved drugs. The new page has sections tailored to the interests of health care professionals, patients, and industry audiences, as well as links to general information for all audiences.














































Do prescription orders or prescription documents have an expiration date?



Answer:


There is no specific provision in statute or rule which says that a prescription document or order has an expiration date. Federal regulations provide that prescriptions for drugs in Schedules III and IV shall not be filled or refilled more than 6 months after the date of issue. Prescriptions for drugs in Schedule II have no specific expiration date. Board rule provides that a pharmacist can refuse to fill or refill a prescription if they believe it is harmful to the patient, not in the patient's best interest or there is a question as to its validity.

























Can patients get their prescriptions from a physician's office free through the patient assistance programs sponsored by manufacturers?



Answer:


It is the Board's position that the provision of patient specific drugs from such programs must follow the statute and rules dealing with out-of-state pharmacies. This would require an out-of-state pharmacy permit and adherence to other statute and rules. See G.S. 90-85.21A.

























Why can't I find pseudoephedrine products on the shelf of my pharmacy?



Answer:


In 2005, the North Carolina General Assembly passed the Methamphetamine Lab Prevention Act. In 2006 Congress passed the Combat Methamphetamine Epidemic Act. Both statutes require that many pseudoephedrine-containing products be stored and sold from behind the pharmacy counter. You may still purchase these products, but you are limited in the amount you can purchase, and you must sign a logbook with each purchase.








Are all pseudoephedrine-containing products only sold from behind the counter?


Answer:

Both statutes require that all tablet or caplet pseudoephedrine products be sold from behind the counter. The federal statute also requires that gel capsule pseudoephedrine products be sold from behind the counter. Liquid pseudoephedrine products may be sold from the pharmacy's shelves.


Why must I sign a logbook when I purchase pseudoephedrine products, and what happens to my information in the logbook?


Answer:

Both statutes require a purchaser of pseudoephedrine tablets or caplets to sign a logbook and provide a name and address. These logbooks must be kept by the pharmacy for two years. The logbooks are not public records and information in them may only be disclosed to law enforcement personnel.


Why can't my child purchase pseudoephedrine products?


Answer:

The North Carolina statute provides that pseudoephedrine tablets and caplets may be sold at retail only to a person at least 18 years of age.














































How long must prescription records be kept in North Carolina?



Answer:


The answer to that question depends on which issue is of most concern to you. Federal law requires that records be kept for controlled substances for two years. The state Pharmacy Practice Act provides that records must be kept for three years. The state Medicaid contract requires that records be kept for five years.

























May I purchase Quinine Sulfate?



Answer:


Federal law (21 C.F.R. 310.546, 310.547) prohibits over-the-counter sale of quinine or quinine salts for the treatment and/or prevention of leg cramps or malaria. The FDA deems any "OTC drug product [containing quinine or quinine salts] that is labeled, represented, or promoted" for the treatment and/or prevention of nocturnal leg muscle cramps or malaria to be a "new drug within the meaning of the [Food, Drug, and Cosmetic Act]." "In the absence of an approved new drug application or abbreviated new drug application, such product is misbranded under [the FD&C] Act."

In 2005, the FDA approved Quinine Sulfate Capsules USP, 324 mg, manufactured by Mutual Pharmaceutical Co., as a prescription-only drug for the treatment of malaria. These capsules are not approved for any other indication, including relief from leg cramps.



 
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