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.

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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.

Are you interested in learning more about Drug Substance Pharma Service? Contact us today to secure an expert consultation!

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.

Spanish Language version - Medicamentos Genéricos: Preguntas y Respuestas (PDF - 213 KB)

• What are generic drugs?
• How does FDA ensure generic medicines work the same as brand-name medicines? 
• Why does a generic drug look different from the brand drug?
• Why do generic medicines often cost less than the brand?
• What standards must generic medicines meet to receive FDA approval?
• Is a generic of my brand-name medicine available?
• How does FDA monitor side effects or safety issues with generic medicines?
• Where can I find more information about generic medicines?

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 the brand-name medicine. In other words, you can take a generic medicine as an equal substitute for its brand-name counterpart.

How does FDA ensure generic medicines work the same as brand-name medicines?

Any generic medicine must perform the same in the body as the brand-name medicine. It must be the same as a brand-name medicine in dosage,  form and route of administration, safety, effectiveness, strength, and labeling (with certain limited exceptions).  It must also meet the same high standards of quality and manufacturing as the brand-name product, and it must be and quality, taken and used in the same way as well. This standard applies to all generic medicines.

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 ensure generic medicines meet these standards, in addition to conducting inspections of manufacturing plants and monitoring drug safety after the generic medicine has been approved and brought to market.

A generic drug may have certain minor differences from the brand-name product, such as different inactive ingredients. 

It is important to note that there will always be a slight, but not medically significant, level of expected 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, a very large research study1 comparing generics with brand-name medicines, found that there were very small differences (approximately 3.5%) in absorption into the body between generic and brand-name medicines. Some generics were absorbed slightly more, some slightly less. This amount of difference is expected and clinically 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. 

Why does a generic drug look different from the brand drug?

Trademark laws in the United States do not allow a generic drug 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.

Why do generic medicines often cost less than the brand-name medicines?

Generic drugs are approved only after a rigorous review by FDA and after a set period of time that the brand product 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.  

Generic drugs 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 abbreviated pathway is why the application is called an “abbreviated new drug application.” 

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 nearly $2.2 trillion from to .

When multiple generic companies are approved to market a single product, more competition exists in the marketplace, which typically results in lower prices for patients.

Bringing more drug competition to the market and addressing the high cost of medicines is one of FDA’s top priorities. In , FDA announced the Drug Competition Action Plan (DCAP) to further encourage robust and timely market competition for generic drugs and help bring greater efficiency and transparency to the generic drug review process, without sacrificing the scientific rigor underlying our generic drug program.

What standards must generic medicines meet to receive FDA approval?

Drug companies must submit an abbreviated new drug application (ANDA) to FDA for approval to market a generic drug that is the same as (or bioequivalent to) the brand product. FDA reviews the application to ensure 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 scientific 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 product.
  • 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 products last for at least the same amount of time as the brand-name product.
• 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 (human studies) 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.

In addition to asking your local pharmacist for assistance, there are three ways to find out if there is a generic of your brand-name medicine available:

• Use Drugs@FDA, a catalog of FDA-approved drug products, including their drug labeling.
  • First, search by brand name.
  • Second, select the brand name product and note which products are listed under the section labeled “Therapeutic Equivalents for ...”
  • Products that include an ANDA (not NDA) number next to the name are generic products.
• Use the online version of the Orange Book.  
  • First, search by proprietary or brand name. Note the active ingredient name.
  • Second, search again by the active ingredient name.
  • Scroll right to find the dosage form (for example: tablet) and strength.
  • Next, scroll right to the TE Code column. If the TE column contains a code beginning with “A,” FDA has approved generic equivalents.
  • Finally, look at the column “Appl No.” If the letter “A” appears before the number, that product is an FDA-approved generic for the brand-name drug.  
  • For very recent approvals, consult First Generic Drug Approvals.

If you are unable to locate a generic 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, which allows 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 a generic of the brand-name medicine.

How Does FDA monitor side effects or safety issues with generic medicines?

FDA takes several actions to ensure safety and quality before and after a new or generic medicine is approved. When a generic drug application is submitted, FDA conducts a thorough examination of the data submitted by the applicant and evaluates information obtained by FDA investigators while inspecting the related testing and manufacturing facilities to ensure that every generic drug is safe, effective, high quality, and substitutable to the brand name drug.

FDA staff continually monitors all approved drug products, including generics, 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) is used or manufactured, and FDA will make recommendations to health care professionals and the public if the need arises.

MedWatch is the FDA’s medical product safety reporting program. Health professionals, patients and consumers can use MedWatch to voluntarily report a serious adverse event, product quality problem, product use/medication error, or therapeutic inequivalence/failure that is suspected to be associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic.

Additional Resource

• Postmarketing Surveillance of Generic Drugs
  Download a high-resolution, printable PDF of this infographic (PDF - 282 KB)

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

1Davit et al. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration. Ann Pharmacother. ;43(10):-97.

2Association for Accessible Medicines. Generic Drug & Biosimilars Access & Savings in the U.S. Report. Available from: http://www.imshealth.com/en/thought-leadership/quintilesims-institute/reports

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