10 Questions You Should to Know about Drug Substance Pharma Service

1. Is it legal to import medicines into the U.S. from other countries?

No. The United States Federal Food, Drug, and Cosmetic Act (The Act) prohibits the interstate shipment (which includes importation) of unapproved new drugs. Thus, the importation of unapproved new drugs, whether for personal use or otherwise, violates the Act and is illegal. Unapproved new drugs include any drugs – including drugs approved in another country but which lack FDA approval -- that have not been distributed in accordance with FDA approval.

If you want to learn more, please visit our website Lianhe Aigen.

FDA recognizes that some individuals may seek treatment with an unapproved new drug in a foreign country and may wish to continue such treatment upon their return to the USA. Likewise, FDA recognizes some individuals suffer from conditions for which no FDA approved treatment exists. FDA’s Regulatory Procedures Manual (RPM)on personal importation, specifically Chapter 9-2 Coverage of Personal Importations, provides FDA field offices with information to consider in deciding whether to object to the importation of an unapproved new drug for personal use. These include, whether:

• the drug is unapproved and intended for use for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means;
• there is no known commercialization or promotion of the drug to persons residing in the U.S. by those involved in the distribution of the product;
• the product is considered not to represent an unreasonable risk;
• the individual seeking to import the product, affirms in writing that it is for the patient’s own use (generally not more than a three-month supply), and provides the name and address of the doctor licensed in the U.S. responsible for his/her treatment with the product or provides evidence that the product is for the continuation of treatment begun in a foreign country.

The information in the RPM is not, however, a license for individuals to import unapproved (and therefore illegal) drugs for personal use into the U.S. Even if all of the factors noted in the guidance are present, the drug remains illegal and FDA may determine that such drugs should be refused entry or seized. The RPM does not create any legally enforceable rights for the public; nor does it operate to bind FDA or the public.

For more information, visit the FDA Import Program.

You may also find information regarding concerns of bringing foreign medications into the U.S. at: Importing Prescription Drugs

2. What are the drug interactions, side effects, and/or adverse events associated with a certain medicine?

The drug labeling, or package insert, that accompanies drug products, is the most complete single source of information on the drug. They are available from your local pharmacist and are also reprinted in the Physician's Desk Reference (PDR), which can be found in many libraries. In addition, the package insert is available from the manufacturer and may often be found on the drug manufacturer's Web site. Labeling for drugs approved after may often be found at Drugs@FDA.

Another option for finding additional information on a drug's side effects is to request this through the FDA's Freedom of information Office (FOI). You can find out more about this option and how to make an FOI request.

3. How do I market an Over-the-Counter (OTC) drug?

Over 100,000 OTC drug products, which contain approximately 700 active ingredients, are currently marketed. OTC drug products are legally marketed in the United States as a result of two types of review by the FDA: OTC drug monograph review or new drug review.

The majority of currently marketed OTC drug products have been evaluated under the OTC drug monograph review. Under this review, the FDA evaluates the active ingredients in products after they have met certain marketing requirements to affirm that they are safe, effective, and properly labeled for their intended uses. This is an active ingredient review, rather than a product-by-product (new) drug review. As a result, the FDA publishes OTC drug monographs that list active ingredients, allowed combinations, and required labeling for classes of OTC drug products (e.g., antacids, cough-cold products). In general, to market an OTC product, the product must meet the standards of the OTC monograph.  OTC monographs specify the allowable ingredients, labeling, dosage, etc. for OTC medications.  The OTC monographs are published in the Federal Register and may be found at: Status of OTC Rulemakings.

If the product differs from the OTC monograph, it is treated as a new drug. For new (and new generic) OTC drug products, review and approval of a product-specific New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA) must occur before marketing is permitted.  Products initially marketed as OTC drugs and products initially marketed as prescription (Rx) drug products may be approved under this new drug review.

For additional information, visit the OTC drugs website.

4.  How do I report an adverse event?

At the FDA, we are interested in learning of adverse experiences that patients encounter, and have implemented the MedWatch program to monitor these experiences. MedWatch is a voluntary system of reporting to FDA any adverse effects and/or product problems. You can find a link to the voluntary reporting form by going to the MedWatch homepage. Click on "How to Report", then "Reporting by Health Professionals" or "Reporting by Consumers". Alternatively, visit the direct address.

You can also call the Division of Drug Information at 301-827-, and request that a MedWatch Voluntary Reporting Form be sent to you.

5.  Why are drug prices so high in the United States?

The FDA does not have the authority to regulate the prices of drug products in the United States. Manufacturers, distributors, and retailers establish these prices. Since some countries' health care systems are government controlled, such as Canada's, drugs sold in these countries may be considerably less expensive than they are in the United States.

You may wish to contact the Federal Trade Commission (FTC) to voice your concerns on the price of drugs. The FTC enforces a variety of Federal antitrust and consumer protection laws. The FTC seeks to ensure that the nation's markets function competitively, and are vigorous, efficient, and free of undue restrictions.  You can contact them at:

Federal Trade Commission
Bureau of Competition
Office of Policy and Evaluation
Room 394
Washington, D.C. 
: 202-326-

We understand that drug prices have a direct impact on the ability of people to cope with their illnesses as well as to meet other expenses. The FDA, however, has no statutory authority to investigate or control the prices charged for marketed drugs. These prices are established by manufacturers, distributors, and retailers.

Several drug manufacturers have patient assistance programs that will make drugs available to consumers at no cost or at a reduced cost.  Financial assistance may also be provided to qualified individuals through the Center for Medicare and Medicaid Services (CMS). To obtain additional information, please contact CMS directly at the following address:

Center for Medicare and Medicaid Services
Security Boulevard
Baltimore MD -
: 410-786-

6.  Why won’t my insurance company pay for certain drugs?

The FDA does not stipulate what drugs insurance companies may cover or to what extent the drug may be covered. However, most insurance companies construct their policies in accordance with the labeling of that particular product. The labeling or Patient Package Insert (PPI) of each product is disseminated by the manufacturer, but has been reviewed and approved by FDA.  We suggest that you contact your health insurance provider directly to discuss the extent of your coverage for prescription medications. You may also wish to contact the State Insurance Commissioner's Office in your state to discuss your concerns.

7. When will a drug be approved?

The FDA is empowered to approve drug products that have been shown to be safe and effective for their labeled use, and we can provide releasable information on products approved for use only in the United States.

FDA requires all drugs to undergo a standard approval process in order to assure that all drugs are safe and effective upon approval. Collecting and reviewing the information necessary to ensure the safety and efficacy of drugs takes a great deal of time.  If you would like to read about the drug review process, please visit "Overview of our role regulating and approving drugs."

If you are seeking information about a drug that is not yet approved, please understand that this information is confidential and belongs to the manufacturer/sponsor developing the drug, so we cannot provide it to the public. You may contact the sponsor directly to inquire about products under development.

8. What is the Investigational New Drug (IND) process?

A: Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND, or Investigational New Drug application, is the means through which the sponsor technically obtains this exemption from the FDA.

The IND application must contain information in three broad areas:

• Animal Pharmacology and Toxicology Studies - Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Also included are any previous experiences with the drug in humans (often foreign use).
• Manufacturing Information - Information pertaining to the composition, manufacture, stability, and controls used for manufacturing the drug substance and the drug product. This information is assessed to ensure that the company can adequately produce and supply consistent batches of the drug.
• Clinical Protocols and Investigator Information - Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. Also, information on the qualifications of clinical investigators -- professionals (generally physicians) who oversee the administration of the experimental compound--to assess whether they are qualified to fulfill their clinical trial duties. Finally, commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations.

For more information, visit the IND application process website.

9. Are dietary supplements FDA approved?

In general, the regulation of dietary supplements, vitamins, herbals, botanicals, and natural products were placed under The Center for Food Safety and Applied Nutrition (CFSAN) by Congress in . 

The Food and Drug Administration (FDA) does not have any information on dietary supplement products for specific conditions or safety of their use and has not pre-cleared their purported claims. Under the Dietary Supplement and Health Education Act (DSHEA) of , the responsibility for determining the appropriateness of using a dietary supplement lies with the consumer, not the FDA.

You may find some useful information on CFSAN's dietary supplement Web site at "Information for Consumers on Using Dietary Supplements" at to help sort out the abundant information on dietary supplements. Tips related to basic points consumers should consider, questions to ask health professionals, suggestions for searching the Web or evaluating research, and ways to check common assumptions are available.

10. How do I find out when a patent or marketing exclusivity expires and when a generic drug will become available? 

Patents and exclusivity work in a similar fashion but are distinctly different from one another. Patents are granted by the Patent and Trademark Office anywhere along the development lifeline of a drug and can encompass a wide range of claims. Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to a New Drug Application (NDA) applicant if statutory requirements are met. Exclusivity was designed to promote a balance between new drug innovation and generic drug competition.

How well do you know about the drugs you are taking?

Whether synthetic or natural (herbal), drugs are intended to act on the body. There always is a chance that they will produce effects that we do not want. Whenever two or more drugs are taken at the same time, there is a chance that one drug will interact with another drug in either a positive or negative way, so it's important to consult your doctor about all drugs you are taking.

Drugs should be used carefully in order to reap the greatest benefit while minimizing unwanted side effects. When used properly, most drugs approved by the Food and Drug Administration do more good than harm.

Make a list of your questions about the medications you are taking and discuss any concerns with your doctor. To start, here are some questions you can ask your doctor.

1. How does the drug work?

• Knowing how the drug works provides the rationale for its use in the treatment of a particular disease. This also promotes adherence to treatment.

2. Why did my doctor prescribe this drug?

• Drugs often have more than one use. Understanding why a drug is prescribed improves your knowledge about the drug and the condition for which it is prescribed.
• This promotes compliance with treatment. It is a good idea to write down why each drug was prescribed to share this information with other health-care professionals or caregivers.

4. What are the possible side effects of the drug?

• Since drugs provide a benefit by modifying processes in the body, it is not surprising that they also have side effects.
• Successful drug therapy produces the desired beneficial effect without unbearable side effects. Therefore, it is important to know what a drug's side effects are so that they can be recognized, prevented, and acted upon appropriately when they occur.

5. Should you use a generic version of the drug?

• Generic drugs work the same as the brand name drugs, but they are cheaper. Purchasing a generic instead of a brand name drug can often reduce the cost of therapy while providing the same benefit.

6. What should you expect the drug to do?

• Some drugs cure the condition for which they are prescribed while other drugs only provide relief from symptoms. Some drugs provide an immediate benefit while other drugs require more time to be effective.
• To determine whether the drug is working as intended, it is important to know the expected result and how long it will take to see that result.

7. How should the drug be taken?

• The optimal dose and timing of ingestion of a drug are determined by scientific studies. Drugs provide their greatest benefit when they are taken as prescribed.
• Deviating from the prescribed dose often leads to failure of the therapy or to side effects. However, in some circumstances (for example, when severe side effects occur), changes in dose may be appropriate, but they should be discussed with a health care professional as soon as possible.

8. What should you do if you miss a dose?

• Despite the best of efforts, eventually everyone misses one or more doses of a medication. The remedy for this situation depends on the drug.
• For some drugs, simply taking the missed dose as soon as possible is appropriate. For other drugs, it is more appropriate to wait and double the next scheduled dose. (However, this can be dangerous with some drugs.)
• Since the recommendations differ for each drug, knowing the correct remedy can prevent the therapy from failing and side effects from occurring.

9. What foods and substances interact with the drug?

• Interactions with drugs are common and they can cause side effects or reduce the beneficial effect of the drug. Sometimes, the interaction may promote a beneficial effect.
• Knowing which interacting agents to avoid while taking a drug (for example, food, and herbal drugs) will prevent failure of therapy and side effects. It is a good idea to let your pharmacist and all health care professionals know the drugs you are taking so potential drug interactions can be avoided.
• Also, ask about alternative treatments and how effective they are.

QUESTION

See Answer

10. How should I dispose of any unused drugs?

To safe guard the health of children, pets, and the environment; and to reduce drug abuse; drugs should be disposed of responsibly.

The FDA recommends the following for safe disposal of unused or expired medications:

• Follow specific recommendations for disposal instructions on the drug label or patient information packet provided with the medication.
• Do not flush drugs down the sink or toilet unless the packet information on the drug specifically instructs to do so.
• Check to see if your community has a drug take-back program that allows the public to bring unused drugs to a specific location for disposal.
• If you do not have access to a disposal program in your area to dispose of unused drugs it is recommended you throw the drugs in the garbage after taking the following steps:
  • Remove the drugs from their original container and mix them with coffee grounds or kitty litter (this makes the drugs less appealing to pets, children, and people who intentionally dig through the trash seeking drugs).
  • Place the mixture in a sealable container, can, or bag to prevent leakage.

Additional tips

• Remove all identifying information on the prescription labels so they are unreadable. This helps protect your identify and personal health information.
• Do not give prescription medications to friends or family members. A medication that is effective for you, may be dangerous for someone else.
• Ask your health care professional or pharmacist if you have any questions about proper disposal of unused or expired medicaitons.
• Disposal of prescription drug disposal methods can be applied to over-the-counter (OTC) drugs.
• Inquire about any special instructions for disposing the unused or expired medications you have taken.

11. Who manufacturers the drug?

• Drug manufacturers often have education materials, programs, and other resources that may help you understand your health condition and its management. They may also have prescription assistance programs.

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Treatment & Diagnosis

Medications & Supplements

Prevention & Wellness

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-.

Contact us to discuss your requirements of Pharmaceutical Solutions. Our experienced sales team can help you identify the options that best suit your needs.

References

Department of Justice, Drug Enforcement Administration. Drug Disposal Fact Sheets.

FDA. How to Dispose of Unused Medicines.