Food Drug and Cosmetics Act

Drug Approval Process

Step 1: in vivo animal studies Primarily evaluate pharmacology and potential toxicities. Once complete, sponsor submits an Investigational New Drug Application ("IND") Step 2: IND Contains preclinical data, proposed use and safety data, and proposed plan for study in humans. Data reviewed by FDA, and decision is made whether to allow sponsor to begin human trials. Step 3: Clinical Trials (Three phases) Once complete, results are tabulated, analyzed and then submitted as a New Drug Application ("NDA") Step 4: New Drug Application (NDA) All data concerning drug efficacy, safety, stability, production methods, packaging and data from the clinical trials are submitted to FDA for review. FDA undertakes an exhaustive review, and if approved, the NDA is placed on file with the FDA, and the drug can be marketed.

Supplemental New Drug Application

Submitted after NDA approved for changes in synthesis, production procedures, manufacturing locations, packaging, labeling, indications, etc.

Medical Device Amendments of 1976

The Amendments clarified the definition of device and categorized medical devices based on risk. Medical devices were required to meet certain performance standards and mandates on recordkeeping and adverse event reporting. The amendments revised the definition of medical device as defined in section 201(h) of the Act and defined a device as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar related article, which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purpose."

Food Drug and Cosmetics Act

The Food and Drug Administration ("FDA") administers the federal Food, Drug and Cosmetics Act ("FDCA"), and is responsible for regulating all aspects of the manufacturing and, to a lesser extent, wholesale distribution of both prescription and non-prescription drugs. All drug manufacturers and repackagers are required to register with FDA. If they fail to register, their products are deemed to be "misbranded."

Dietary Supplements

"Food Products" Dietary supplement makers can promote their products using "structure function" claims, but still cannot use "drug" claims. A dietary supplement label can say "Regular use of this product will help maintain healthy cholesterol levels", but cannot say" "Regular use of this product will help prevent heart disease". Supplement labels must also carry a disclaimer stating that the claims made on the label "have not been evaluated or approved by the Food and Drug Administration".

Drug Quality and Security Act (New Federal Law)

(1) 503A - Traditional compounding • If done properly, exempt from Food Drug and Cosmetics Act NDA, cGMP and labeling requirements • Must operate in compliance with state law • Patient specific prescription required. (2) 503B - addresses "Outsourcing Facilities" • Large scale compounders can elect to register with FDA as an Outsourcing facility; strictly voluntary. • Often, but not always sterile compounding • Key - no identifiable patient; customer is the doctor, hospital or clinic. • If operate in compliance with 503B, exempt from NDA and labeling requirements, but must still adhere of cGMP requirements • cGMPs are very different from USP <797> • Very onerous requirements • FDA is supposed to implement regulations that address cGMP requirements for Outsourcing Facilities, but has instead issued a series of guidance documents to regulate compounders

Substances Regulated by FDA

(1) Foods (e.g. dietary supplements, bottled water, food additives, infant formulas, and other food products (although the U.S. Department of Agriculture plays a lead role in regulating aspects of some meat, poultry, and egg products) (2) Drugs (e.g. prescription drugs [both brand-name and generic], non-prescription [over-the-counter] drugs (3) Biologics (e.g. vaccines, blood and blood products, cellular and gene therapy products, tissue and tissue products, allergenics) (4) Medical Devices (e.g. simple items like tongue depressors and bedpans, complex technologies such as heart pacemakers, dental devices, surgical implants and prosthetics) (5) Electronic Products that give off radiation (e.g. microwave ovens, x-ray equipment, laser products, ultrasonic therapy equipment, mercury vapor lamps, sunlamps) (6) Cosmetics (e.g. color additives found in makeup and other personal care products, skin moisturizers and cleansers, nail polish and perfume) (7) Veterinary Products (e.g. livestock feeds, pet foods, veterinary drugs and devices) (8) Tobacco Products (e.g. cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco)

Under Illinois and federal law, pharmacies are no longer permitted to compound "for office use" unless...

(1) They have a patient specific prescription, and are simply delivering a patient specific compounded product to the doctor's office, or (2) Are engaged in "anticipatory compounding" and delivering the product to the office prior to, but in anticipation of, receiving a patient specific prescription. Anticipatory compounding - pharmacist compounds small amounts of drug before receiving prescription, based on previously filled valid prescriptions within an established practitioner - patient - pharmacist relationship, and the RX is kept on file.

Adulterated Drugs

A drug is deemed adulterated if: • it consists in whole or in part of any filthy, putrid, or decomposed substance; or • it has been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or • it is a drug, and the methods used in, or the facilities or controls used for manufacturing, packaging, etc. are in violation of current good manufacturing practices; or • its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health; or • it bears an unsafe color additive for purposes of coloring only; or • drug is labeled as if recognized in an official compendium2, but differs in strength, quality or purity from that represented • strength or quality or purity falls below compendium standards; or • drug is not listed in an official compendium, and its strength differs from, or its quality and purity falls below what is represented on label; or • any substance has been mixed with the drug to reduce the drug's strength, or any substance has been substituted for the drug.

Commercially Available Products

A pharmacist is permitted to compound a drug that differs slightly from a commercially available product in response to an individual patient's medical need that the pharmacist has documented after consulting with the patient's physician. This may also be permitted in the case of a drug shortage, when the commercially available product is not available.

Prescription Drug User Fee Act (PDUFA) of 1992 (reauthorized in 1997 and 2002)

Allows the FDA to accept user fees from drug and biologic companies in return for committing to review new drug and biologic products within certain time frames. PDUFA has been credited with speeding the approval of new products.

Prescription Drugs

All drugs must have labeling that describes in layman's terms how to use the drug safely and effectively. The only exemption from this labeling requirement is if the drug cannot be made safe by simply adding a warning or directions for use to the label. Those drugs are called "prescription drugs" or "legend" drugs, and can be obtained lawfully only pursuant to a prescription. Thus, prescription drugs are drugs which: • Cannot be made safe by including adequate directions for use (and is therefore exempt from requirement that it contain adequate directions for use or be considered misbranded). • Medical experts agree that adequate directions for consumer self-medication cannot be provided. • Is limited to dispensing by a prescription because it is habit forming, toxic, has a potential for harm, or its NDA limits it to use under a doctor's supervision. • Label must contain "legend" stating: "Caution: Federal law prohibits dispensing without a prescription." (Hence the name "legend drugs".) (Now: "Rx Only")

Tamper Resistant / Tamper Evident Packaging

An OTC drug product (except a dermatological, dentifrice, insulin, or lozenge product) for retail sale that is not packaged in a tamper-resistant package or that is not properly labeled under this section is adulterated

**Food and Drug Act of 1906

As the new century began, widely publicized reports began to highlight severe problems in our country's food and drug industry. One of the most dramatic of these reports was Upton Sinclair's book, The Jungle, which graphically illustrated problems in the nation's meat processing industry. Samuel Hopkins Adams' magazine articles concerning what he called the Great American Fraud sparked similar concerns about fraudulent patent medicines containing dangerous ingredients such as alcohol, cocaine, morphine, and opium advertised by their makers as cures for diseases such as cancer and tuberculosis. These and other reports spurred Congress to pass and President Theodore Roosevelt to sign the 1906 Food and Drug Act. The 1906 Act prohibited the marketing of adulterated (meaning, contaminated) and misbranded food and drugs. Under the Act, such products were subject to seizure by the government. However, the law did not limit the claims a manufacturer can make with respect to their product as long as the product was correctly identified. The Act also did not require premarket inspections and approval.

Pregnancy Warnings

Category A - Adequate, well controlled studies reveal no risk to fetus during 1st, 2nd and 3rd trimesters of pregnancy. Category B - No adequate, well controlled studies have been conducted in pregnant women, but animal reproduction studies have failed to demonstrate a risk to the fetus. Category C - Safety of the drug during human pregnancy has not been established, and animal studies are either positive for fetal risk, or have not been conducted. Drug should not be used in human females during pregnancy unless the potential benefit outweighs the potential risk to the fetus. Category D - There has been positive evidence of risk to the human fetus, based mainly on adverse reaction data from investigational or marketing experience. Drug should be administered only if potential benefits to pregnant women may be acceptable despite its potential risks. Category X - Studies in animals, or reports in pregnant women, indicate that the risk of damage to the fetus clearly outweighs any possible benefit to the pregnant woman.

Prescription Drug Amendments of PDMA 1992

Consistent with these concerns, the PDMA requires companies to account for disposition of drug samples and prohibits reimportation of drugs exported to other countries. Samples or donated pharmaceutical products generally cannot be sold to consumers. If a company becomes aware that a product has been stolen or that there is a "significant loss" of product, it should conduct an investigation and report the situation to the FDA within 5 days. The PDMA also impacts the distribution and storage of drugs by imposing certain requirements on wholesalers, such as ensuring that drugs are stored securely and that wholesalers provide the name and lot number of the drug to purchasers. According to the FDA report, wholesalers who "serve as middlemen between drug manufacturers and prescription drug dispensers" such as CVS and other retail pharmacies are supposed to be licensed by the states pursuant to FDA requirements. The most recent significant development in this area is the requirement that prescription drug wholesalers that do not qualify as an "authorized distributor of record" are required to provide a "pedigree" with each wholesale distribution of drug. The PDMA states that an authorized distributor of record is a distributor that has an "ongoing relationship" with a manufacturer to distribute that manufacturer's drug products. The PDMA does not define "ongoing relationship," but in 1999, FDA published final regulations that defines "ongoing relationship" to include a written agreement between manufacturer and distributor. FDA repeatedly delayed implementation of this requirement but they finally became effective on December 1, 2006.

Dietary Supplement Health and Education Act (DSHEA) of 1994

Dietary supplements defined as vitamins, herbs, and minerals are exempt from food additive provisions. This means that the FDA must prove the supplements are unsafe as opposed to manufacturers' having to demonstrate the safety of these products. DSHEA established labeling requirements, allowed "nutritional support statements" describing the effect of a supplement, and provided for the FDA to issue good manufacturing practice regulations for the dietary supplement industry. Before DSHEA, supplements were regulated in the same way as foods, food ingredients, or food additives. Good Manufacturing Practice regulations for the dietary supplement industry have recently been published. The regulations require supplement manufacturers to submit to FDA inspections and "assure potency, purity, and consistency in dietary supplement products".

National Drug Code Numbers

Drug products are identified and reported using a unique, three- segment number, called the National Drug Code (NDC), which is a universal product identifier for human drugs. The number is a series of 10 or 11 digits that are designed to identify the manufacturer, the drug, and the package size. Example: NDC Number 1234-5678-90 1234 - Manufacturer 5678 - ID of Drug 90 - ID of Package

Orphan Drug Act of 1983

Drugs intended for the treatment of "rare diseases and conditions" may be designated orphan drugs under the 1983 Orphan Drug Act, which was intended to help promote research on rare diseases, substance abuse treatments, or products intended to treat diseases in third-world nations

Non-Prescription Drugs ("Over the Counter" or "OTC")

Drugs which are recognized by experts to be safe and effective. Not considered to be "misbranded" if manufactured in accordance with GMPs and labeled with instructions for layman that indicate their safe and effective use.

Misbranding Drugs

Drugs which are sold, dispensed or distributed in violation of the labeling requirements of FDCA are misbranded. Under federal and Illinois law, a drug is misbranded under the following circumstances: • if it's *labeling (see below)is false or misleading in any particular; • if its packaging fails to identify the name and address of the manufacturer, packager or distributor, and quantity of drug; • if any word, statement or other information required by law to be on the label or labeling is not prominent, conspicuous and readable; • if the drug contains any quantity of a habit forming substance, and the labeling fails to identify the name and proportion of the substance and in juxtaposition thereto the phrase "Warning - May be habit forming"; • if either established name or, for multi-ingredient products, each active ingredient, is not identified on label; • if it fails to contain "adequate directions for use" and adequate warnings, unless exempt, or fails to contain information required by NDA; • if not packaged and labeled in accordance with USP/NF specifications; • if the drug is liable to deterioration, and labeling does not contain warnings to that effect; • if it has a misleading container, imitates another drug, or is offered for sale under the same of another drug; and • the dosage, frequency, duration or route of administration suggested in the labeling is dangerous.

Package Insert Requirements - Estrogen Products

FDA concludes that the safe and effective use of drug products containing estrogens requires that patients be fully informed of the benefits and risks involved in the use of these drugs. Accordingly, except as provided in paragraph (e) of this section, each estrogen drug product restricted to prescription distribution, including products containing estrogens in fixed combinations with other drugs, shall be dispensed to patients with a patient package insert containing information concerning the drug`s benefits and risks. An estrogen drug product that does not comply with the requirements of this section is misbranded under section 502(a) of the Federal Food, Drug, and Cosmetic Act.

Seizure

FDA may "seize" drugs which are "misbranded" or "adulterated." The physical isolation of drug while FDA or state agency files a civil lawsuit.

Food and Drug Modernization Act (FDAMA) of 1997

FDAMA established fast-track approval for certain new drugs and accelerated approval for innovative devices by exempting certain devices from premarket notification requirements. The Act also allowed the FDA to use expert panels in the drug approval process, regulated health claims in food, reauthorized the Prescription Drug User Fee Act, and provided federal requirements governing compounding. However, the compounding part of this law is not being enforced by FDA because of ambiguity created by certain federal court decisions

The Prescription Label Requirements

Federal Requirements: (1) Name and address of dispenser (pharmacy); (2) Serial number of prescription; (3) Date of RX or date of filling (refer to state law); (4) The name of the prescriber; (5) Name of the patient, if stated on the prescription; (6) Directions for use, including precautions, if any, as indicated on prescription. **Illinois requires drug name to appear

**Federal Food, Drug and Cosmetic Act [FD&C Act] of 1938

In 1937, nearly 100 people died after ingesting a product called Elixir Sulfanilamide, which was prepared using a chemical called diethylene glycol. Although the manufacturer technically violated the 1906 Act because the product was called an elixir (by definition this is supposed to contain alcohol, and this product did not), the company's failure to test the product for safety and to label the product adequately were not violations of the law. The 1938 Act was passed to ensure that such a tragedy would not occur again. Among other things, the 1938 Act did the following: • Compelled manufacturers to demonstrate to the FDA the safety of new drugs prior to marketing; • Allowed the FDA to inspect manufacturing facilities; • Allowed the FDA to seek injunctions from courts; and • Provided detailed legal definitions of drug, devices, cosmetics, and labeling

**Durham-Humphrey Amendment of 1951

In 1951, the Act was amended to formally distinguish between prescription and over-the-counter drugs. Until that time, consumers could purchase all drugs over-the-counter. Prescription drugs were required to contain a warning that the drugs could be dispensed legally only with the authorization of a health professional. Note: This is one law that you should know by name.

**Anti-Tampering Regulations

In 1982, 7 people died after Tylenol capsules were contaminated with cyanide. Tylenol maker Johnson & Johnson recalled $100 million worth of the product and introduced "tamper-resistant" packaging. After similar incidents in 1986, the company replaced capsules with caplets, which were harder to contaminate. FDA anti-tampering regulations require that "cosmetic liquid oral hygiene products" and vaginal products, contact lens solutions, and most over-the-counter drugs to be packaged in tamper-resistant packages. Products' packaging must be "distinctive by design," and the package labeling must indicate to consumers what tamper-resistant measures are being used. The Federal Anti-Tampering Act makes tampering with consumer products a felony punishable by up to 10 years in jail. Tamper-resistant packaging is defined as a package that has "an indicator or barrier to entry, which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred." According to the FDA, blister packs (tablets or capsules "individually sealed in clear plastic or plastic compartments with foil or paper backing"), film wrappers ("transparent film - wrapped securely around the entire product container"), aerosol containers ("believed to be inherently tamper-resistant because of their design"); tape seals; break-away caps, and foil paper or plastic pouches that "must be torn or broken to obtain the product" are examples of anti-tampering measures.

Ipecac Syrup

Ipecac syrup is available for sale without prescription, provided that it is packaged in a quantity of 1 fluid ounce (30 milliliters), and its label bears the following, in a prominent and conspicuous manner: • A statement conspicuously boxed and in red letters, to the effect: ``For emergency use to cause vomiting in poisoning. Before using, call physician, the Poison Control Center, or hospital emergency room immediately for advice.'' • A warning to the effect: ``Warning--Keep out of reach of children. Do not use in unconscious persons. Ordinarily, this drug should not be used if strychnine, corrosives such as alkalies (lye) and strong acids, or petroleum distillates such as kerosine, gasoline, coal oil, fuel oil, paint thinner, or cleaning fluid have been ingested.'' • Usual dosage: 1 tablespoon (15 milliliters) in persons over 1 year of age.

OTC Monograph Info

Is developed for therapeutic classes of ingredients that are generally recognized as safe and effective (also referred to as "GRAS/E" No FDA approval needed by manufacture to market a product continuing an ingredient covered under an OTC monograph.

Repackaging OTC Products

Label must contain same information as is required for commercial product: • established name of the product, and its pharmacological category; • name and address of the manufacturer, packer or distributor; • net contents of product, by weight or numerical count; • the established name of all active ingredients and quantity of certain other ingredients, whether active or not; • name of any habit forming drugs in the product; • instructions for safe storage; • cautions and warnings needed to protect the consumer; and • adequate directions for safe and effective use. NOTE: Does not apply to hospital repackaging for "own use".

Labeling

Labeling is a very broad term, and includes (i) actual label; (ii) any written, printed, or graphic material upon any container (not just immediate container); and (iii) any wrapper, or written, printed or graphic matter accompanying the product. Labeling includes: • package insert; • drug advertisements; • information in publication such as PDR; and • promotional materials, including newsletters and literature used in promotion.

Virus-Toxin Law of 1902

One of the first such incidents was associated with a vaccine. After patients suffered injuries from diphtheria vaccine "contaminated with tetanus," Congress passed the Virus-Toxin law (also referred to as the Biologics Control Act), which required licensing of biologics establishments, inspections of vaccine manufacturers, and premarket approval of vaccines and other products

Estrogen Distribution Requirements in Acute Care Hospitals or Long Term Care Facilities

Patient package inserts for estrogens dispensed in acute-care hospitals or long-term care facilities will be considered to have been provided in accordance with this section if provided to the patient before administration of the first estrogen and every 30 days thereafter, as long as the therapy continues.

Post Marketing Surveillance

Phase 4 Studies - monitor use of drug for additional information regarding safety and effectiveness. Manufacturer collects data, and submits yearly reports to FDA. Note: reporting of adverse effects by health care practitioners to FDA or the manufacturer is voluntary; reporting by manufacturer of information received is mandatory.

Abbreviated New Drug Application

Process by which generic products are approved following expiration of patent held by innovator company; proof that the generic drug's pharmacokinetics, bioavailability and clinical activity are similar to the innovator product is required.

Class I Recall

Reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death

**Kefauver-Harris Amendment of 1962

Reports of birth defects in European nations caused by thalidomide, a drug about to be introduced into the United States, highlighted the need for more FDA regulation. Among other things, the amendment requires drug manufacturers to show the effectiveness of their products as well as its safety, to report adverse events to the FDA, and to ensure that their advertisements to physicians disclose the risks as well as the benefits of their products. Informed consent was required from participants in clinical studies. The FDA also was given jurisdiction over prescription drug advertising. In addition, the agency was required to approve a regulatory submission known as a new drug application before a company could market a new drug and be allowed to issue good manufacturing practice guidelines governing how drugs were to be manufactured. Inspection of drug manufacturers was mandated every 2 years. NOTE: This is another law that you should know by name.

Nutrition Labeling and Education Act (NLEA) of 1990

The NLEA allowed the use of FDA-approved health claims on food labels and required a uniform format for labels that includes serving size, contents, calories, nutrients, and the recommended daily allowance of nutrients for which such daily values have been established; lists of ingredients, and the number of servings per container. Certain foods such as those served in restaurants are exempt from these requirements. Because of the NLEA, dietary supplement manufacturers now can make health claims without being considered drugs.

**Prescription Drug Marketing Act (PDMA) of 1987

The PDMA was passed by Congress in 1987 "because there were insufficient safeguards in the prescription drug distribution system to prevent the introduction and retail sale of substandard, ineffective, or counterfeit drugs and that a wholesale drug diversion submarket had developed that prevented effective control over, or even routine knowledge of, the true sources of the drug." Congress also expressed concern that samples provided to doctors were being sold to consumers rather than freely distributed as intended by drug manufacturers. Enacted in 1987, the Prescription Drug Marketing Act amends the FDCA to: • Requires states to license wholesale distributors of prescription drugs. • Ban the reimportation of prescription drugs, except by the manufacturer or for emergency use. • Mandate storage, handling, and recordkeeping requirements for drug samples. A "drug sample" is defined as "a unit of prescription drug that is not intended to be sold and is intended to promote the sale of the drug. Samples may only be distributed by a practitioner licensed to prescribe, or to the pharmacy of a hospital or health care entity (at the written request of a prescriber). • Ban the trafficking in or counterfeiting of drug coupons • Prohibit the resale of prescription drugs purchased by hospitals or health care facilities, with certain exceptions.

Recall

The correction or removal, and notification to the company, of a product which is in violation of the law.

Durham-Humphrey Amendments To FDCA

The drug control law most likely to be violated by the pharmacist! Provides that prescription drugs can be dispensed: • only upon written RX of practitioner licensed by law to administer such drugs; • upon the practitioner's oral RX, which is promptly reduced to writing and filed by RPh; • by refilling where authorized by the prescriber; • by administration directly by the prescriber. The DHA prohibit unauthorized refills; CS have additional refill requirements. "Prescriber" - determination of who may prescribe is made by state law.

OTC Products Containing Salicylates Label Requirements

The label of any oral drug preparation intended for sale without prescription and which contains any salicylate ingredient (including aspirin, salicylamide, other salicylates, and combinations) must conspicuously bear, on a clearly contrasting background, the warning statement: "Keep out of reach of children [highlighted in bold type]. In case of overdose, get medical help or contact a Poison Control Center right away". Effervescent preparations and preparations containing para-aminosalicylate as the only salicylate ingredient are EXEPMTED from this labeling requirement.

Class III Recall

Use of or exposure to product is not likely to cause serious adverse health consequences.

Class II Recall

Use of or exposure to product may cause a temporary or medically reversible adverse health consequence, or where the probability of serious health consequences is remote.

Regulation of Alcohol

• Alcohol is regulated by the federal Bureau of Alcohol, Tobacco and Firearms. • If you are asked about alcohol, pharmacies obtain alcohol used for compounding using form ATF-11. • The type of alcohol sold is 95% ethanol (190 proof grain alcohol). • This alcohol is "tax exempt", meaning that pharmacies are not charged the federal alcohol tax when purchasing alcohol for compounding.

Aspirin Tablets

• Aspirin tablets especially made for pediatric use be produced only in 1\1/4-grain size to reduce the hazard of errors in dosage; • By June 1, 1967, manufacturers and distributors of 1\1/4-grain size aspirin tablets discontinue the distribution of such tablets in retail containers containing more than 36 tablets, to reduce the hazard of accidental poisoning; • The flavoring of 5-grain aspirin tablets or other "adult aspirin tablets'' be discontinued; and • Labeling giving undue emphasis to the pleasant flavor of flavored aspirin tablets be discontinued.

Phases of Clinical Trials

• Phase 1 - small group of healthy subjects receive drug; evaluation of toxicological, pharmacokinetic and pharmacologic properties; assessment of safety of drugs in humans. • Phase 2 - drug is given to a larger group (100 or more) of patients with the disease or symptoms of the condition claimed to be treated by the drug; determine effectiveness and obtain information about dosing, relative safety and adverse effects. • Phase 3 - drug given to large groups of patients (sometimes thousands) in several geographical locations as part of controlled clinical trials; obtain data concerning drugs effectiveness compared to placebo; most studies are double blinded.

Estrogen Drug Product Package Insert Contents

• The name of the drug. • The name and place of business of the manufacturer, packer, or distributor. • A statement regarding the benefits and proper uses of estrogens. • The contraindications to use, i.e., when estrogens should not be used.• A description of the most serious risks associated with the use of estrogens. • A brief summary of other side effects of estrogens. • Instructions on how a patient may reduce the risks of estrogen use. • The date, identified as such, of the most recent revision of the patient package insert. NOTE: This requirement does not apply to estrogen-progestogen oral contraceptives. Labeling requirements for these products are set forth in § 310.501 (see below).

A drug is a substance which is...

• recognized in USP/NF or Homeopathic Pharmacopoeia; • intended for use in DIAGNOSIS, CURE, MITIGATION, TREATMENT OR PREVENTION OF DISEASE ; • NON-FOOD ARTICEL INTEEDED TO AFFECT STRUCTURE OR FUCNTION OF THE BODY; or • intended to be used as a component of an item falling within any of these categories.