Regulation of Medications

A soap that cleanses and treats acnes is regulated as a... 1. Drug 2. Cosmetic 3. Soap

1. Drug (because it is treating a disease)

A soap that cleanses and also beautifies and moisturizes is regulated as a... 1. Drug 2. Cosmetic 3. Cosmetic/ drug combination 4. Soap

2. Cosmetic

WHICH LAW Creates fast track approval process for drugs intended for serious or life-threatening disease.

FDA Modernization Act of 1997

WHICH LAW Eliminated the manufacturer's requirement that certain substances must be labeled: "Warning - May be habit forming."

FDA Modernization Act of 1997

WHICH LAW Encourages drug manufacturers to perform pediatric studies of drugs by providing them with additional 6 months of marketing exclusivity.

FDA Modernization Act of 1997

WHAT IS Generic Drug

"The same as a brand name drug in dosage, safety, strength, how it is taken, quality, performance, and intended use. A generic drug can be substituted for the brand name drug. FDA bases evaluations of substitutability, or "therapeutic equivalence, "of generic drugs on scientific evaluation". By law, a generic drug product must contain the identical amounts of the same active ingredients as the brand name product. Drug products evaluated as "therapeutically equivalent" can be expected to have equal effect and no difference when substituted for the brand name product".

Implications of DSHEA for Pharmacists

-Provide accurate product information and assist patients with product selection. -When possible, steer patients to products conforming to USP/NF standards or at least to products in which manufacturers can attest to quality and uniformity standards. -Counsel, educate and provide advice to patients about the use of these products for a disease, especially when asked. Display certain publications (such as articles, book chapters, books and abstracts of peer reviewed scientific publications) used in conjunction with the sale of dietary supplements. -Reprinted in their entirety -Not be false or misleading -Presented with other publications about the product, if available, to give balanced view -Physically separate from the actual product No information appended to them by sticker or other method -DO NOT: Promote dietary supplements on the basis of unapproved health or disease claims. This could violate the FDCA and the TN Board of Pharmacy rules.

Acceptable Structure/Function Claims for Dietary Supplements (Part C)

-Statements that the product will benefit a classical nutrient deficiency disease as long as it also discloses the prevalence of the disease in the U.S. -Statements that describe the role of the dietary supplement in affecting the structure or function of the body. -Statements that characterize the documented mechanism by which a nutrient or dietary supplement acts to maintain structure or function. -Statements describing the general well-being from consumption of a nutrient or dietary ingredient (e.g., energizer, relaxant, muscle enhancement).

Manufacturers' Claims for Dietary Supplements

1) Drug manufacturers may claim that their product will diagnose, cure, mitigate, treat, or prevent a disease. 2) Manufactures of dietary supplements cannot make these claims. 3) Manufacturers of dietary supplements may make the following types of claims: -Health claims describe relationship between product and reducing the risk of a disease- related condition. -Nutrient content claims describe the relative amount of a nutrient in a product. -Structure/function claims describe how a product may affect the organs or systems of the body (cannot mention specific disease). -General wellbeing claims -Claims related to a nutrient deficiency disease.

Dietary Supplements (Health or Disease Claims Part B)

1) Unqualified health claims: Authorized pursuant to the "significant scientific agreement" standard. 2) Qualified: May be made when the claim does not meet the significant scientific agreement standard and the claim would be misleading without the qualification. -Allowed when there is more evidence for the claim than against it. -Must be truthful and not misleading and indicate the level of scientific support. -"Scientific evidence suggests, but does not prove". -"Some evidence shows the nutrient may be beneficial, but there is insignificant scientific evidence to prove the effect"

A moisturizer that claims sun protection is regulated as... 1. Drug 2. Cosmetic 3. Cosmetic/ drug combination 4. Cosmeceutical

3. Cosmetic/ drug combination (moisturizer is a cosmetic and the ability to protect the skin from the sun is a structure/function claim)

A soap is which of the following? 1. Drug 2. Cosmetic 3. Cosmetic/ drug commination 4. None of the above (depends)

4. None of the above (depends)

Cosmetics vs Drugs

A cosmetic may become a drug if its manufacturer promotes it for a therapeutic purpose, despite the product chemistry Standard used by courts to determine whether manufacturer's claims make it a drug What an "ignorant, unthinking, and credulous" consumer would believe Not what a reasonable consumer would believe Examples of Claims Lotion composed of bovine albumin and distilled water "lift out puffs" or gives a "facelift without surgery" (FDA won) Lotion being of "pure protein" and causing an "astringent sensation" (FDA loss)

WHAT IS Counterfeit Drug

A drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufactured, processed, packed or distributed such drug and which thereby falsely purports or is represented to be the product of, or have been packed or distributed by such other drug manufacturer, processor, packer or distributor.

WHAT IS THE Definition of Dietary Supplement

A product that is intended for ingestion, is intended to supplement the diet, and contains any one or more of the following: A vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by humans to supplement the diet by increasing the total dietary intake, a concentrate, a metabolite, constituent, extract, or combination of the previous.

Health claims have 2 essential components

A substance (whether a food, food component or dietary supplement) and a disease or health-related condition Example: -Acceptable: "Adequate calcium throughout life may reduce the risk of osteoporosis" -Unacceptable: "Adequate calcium throughout life may prevent osteoporosis"

WHAT IS Drug Sample

A unit of drug product not intended to be sold It is intended to promote the sale of the drug

WHAT IS Federal Definition of Device

Any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or related article which is: -Recognized in the USP/NF or HPUS or any supplement. -Intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals. -Intended to affect the structure or any function of the body of humans or animals but are not foods. Examples of devices include infusions pumps, cardiac pacemakers, and heart monitors.

Federal Definition of Cosmetic

Article intended to be rubbed, poured, sprinkled, sprayed on, introduced into or otherwise applied to the human body for the purpose of cleansing, beautifying, promoting attractiveness, or altering the appearance. Any component of the above articles is considered a cosmetic. Cosmetics cannot make structure/function claims. Soap is not considered a cosmetic when: The bulk of nonvolatile matter in the product consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compound, and the product is labeled, sold, and represented solely as a soap

Tennessee Definition of Cosmetic

Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part of the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance; and articles intended for use as a component of a cosmetic, except that "cosmetic" does not include soap

WHAT IS Tennessee Definition of Food

Articles used for food or drink for human or other animals, chewing gum, and articles used for components of any food

WHICH LAW Encourages manufacturers to conduct research for new uses of drugs and to submit supplemental NDAs for these uses (SNDA).

FDA Modernization Act of 1997

WHAT IS Tennessee Definition of Drug

Articles, not including devices or their components, parts or accessories, that are: (A) Recognized in the official United States Pharmacopoeia, Official Homeopathic Pharmacopoeia of the United States, Official National Formulary, or any supplement to any of them; (B) Intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals; (C) Intended, other than food, to affect the structure or any function of the body of humans or other animals; and (D) Intended for use as a component of drug.

WHICH LAW Requires manufacturers to establish the safety of color additives in foods, drugs, and cosmetics. FDA can approve a color for one use but not others (e.g., external use only). Contains an anti-cancer provision, known as the Delaney Clause, which prohibits the approval of any color additive that might cause cancer.

Color Additives Amendment of 1960

Which agency administers the Tennessee Food Drug and Cosmetic Act?

Department of Agriculture

WHICH LAW 1-Defines dietary supplements.

Dietary Supplement Health and Education Act of 1994

WHICH LAW Mandates FDA regulate dietary supplements (DS) more a special type of food than as a drug. No premarket approval. -Manufacturer determines whether product is safe and whether claims are substantiated by adequate evidence -For new products manufacturer must provide FDA with evidence it relied on to prove the claims

Dietary Supplement Health and Education Act of 1994

WHICH LAW 2-Permits manufacturers to make certain claims that otherwise would have been illegal under the FDCA.

Dietary Supplement Health and Education Act of 1994

WHICH LAW Prohibits FDA from regulating DS as food additives. FDA must prove that a DS is unsafe before it can remove the product from the market

Dietary Supplement Health and Education Act of 1994

WHICH LAW Defines dietary supplements. Permits manufacturers to make certain claims that otherwise would have been illegal under the FDCA. Regulate dietary supplements more like food than drugs.

Dietary Supplement Health and Educational Act of 1994

WHICH LAW Also known as the Hatch-Waxman Amendment

Drug Price Competition and Patent Term Restoration Act of 1984

WHICH LAW Gives patent extensions, in certain cases, to innovator drugs

Drug Price Competition and Patent Term Restoration Act of 1984

WHICH LAW Streamlines the generic approval process (Generics don't have to go through phase 1 and 2 trials, and phase 3 is shorten from proving efficacy to proving only bioavailability)

Drug Price Competition and Patent Term Restoration Act of 1984

WHICH LAW 1) Establishes exemptions from certain FDA rules for traditional compounding (within normal practice of pharmacy). 2) Establishes outsourcing facilities (compounding outside normal practice of pharmacy). -Optional registration with FDA -Exemption from certain FDA rules -Good manufacturing practices must be met -FDA inspections

Drug Quality and Security Act of 2013 Title I, Compounding Quality Act

WHICH LAW includes Key provisions include: product identification, product tracing, product verification, detection and response, notification, wholesaler licensing, and third-party logistics provider licensing (those who provide storage and logistical operations related to drug distribution)

Drug Quality and Security Act of 2013 Title II, Drug Supply Chain Security Act

WHICH LAW Also known as the Prescription Drug Amendment. Authorized FDA to classify drugs either as prescription or OTC.

Durham-Humphrey Amendment of 1951

WHICH LAW Required legend on prescription drug that states, "Caution: Federal Law prohibits dispensing without a prescription"

Durham-Humphrey Amendment of 1951

WHICH LAW DID THIS 1. Allows FDA to order Product recalls 2. Public register of clinical trials 3. Changes to phase IV studies (post-market studies) 4. Risk Elevation and Mitigation Strategies (REMS) 5. FDA's authority over postmarket labeling 6. Postmarket drug safety information website 7. Notification to patients to report drug adverse events (side effect statements) 8. Direct to Consumer advertising changes

FDA Amendments Act of 2007

WHICH LAW Ensures DS are produced in good quality manner and do not contain contaminants or impurities and are accurately labeled.

FDA Dietary Supplement Final Rule 2007

WHICH LAW Requires Current Good Manufacturing Practices for dietary supplements.

FDA Dietary Supplement Final Rule 2007

WHICH LAW SAID THIS? -Manufacturers must evaluate the identity, purity, strength, and composition of their DS. -If a DS contains a contaminant or does not contain the dietary ingredients represented on their labeling, the FDA would consider them misbranded or adulterated.

FDA Dietary Supplement Final Rule 2007

WHICH LAW Clarifies the conditions under which pharmacists may perform extemporaneous compounding of prescriptions. Exempts pharmacists from the strict regulatory federal GMP standards and requirements for submission of NDA.

FDA Modernization Act of 1997

WHICH LAW Creates databank on information on clinical trials and authorizes scientific panels to review clinical investigations.

FDA Modernization Act of 1997

WHICH LAW Expands rights of manufacturers to disseminate unapproved use information, must specify use not approved by FDA.

FDA Modernization Act of 1997

WHICH LAW Increases FDA's public accountability.

FDA Modernization Act of 1997

WHICH LAW Requires compliance plan developed in consultation with industry representatives, scientific experts, health care professionals, and consumers.

FDA Modernization Act of 1997

WHICH LAW Streamlined regulatory procedures to ensure the expedited availability of safe and effective drugs and devices.

FDA Modernization Act of 1997

WHICH LAW replaced prescription drug legend with "Rx only"

FDA Modernization Act of 1997

WHICH LAW Mandates priority review for breakthrough technologies. Allows FDA to contract with outside scientific experts for review of medical device applications.

FDA Modernization Act of 1997 Medical Devices:

WHICH LAW -Expands FDA's authority over OTC drugs. -Establishes ingredient labeling requirements for inactive ingredients. -Preempts States from establishing labeling requirements for OTC drugs and cosmetics when federal requirements exist.

FDA Modernization Act of 1997 Over-the-Counter Drugs

WHICH LAW 1. Regulates medical devices 2. Establishes performance goals 3. Sets user fees 4. Modifies approval of clinical trials 5. Provides pathway for risked-based classification 6. Expands FDA's post-market surveillance capabilities 7. Shortens timelines for appeals 8. Changes the process for reclassification of devices

FDA Safety and Innovation Act of 2012

WHICH LAW Required components added to food products must receive premarket approval for safety. Contains an anti-cancer provision, known as the Delaney Clause, which prohibits the approval of any food additive that might cause cancer

Food Additives Amendment of 1958

WHICH LAW Required that any new drug could not be marketed until it had been proven safe when used according to directions on the label.

Food, Drug, and Cosmetic Act of 1938

WHICH LAW Required that labels include adequate directions for use and warnings about habit-forming drugs that were in the product.

Food, Drug, and Cosmetic Act of 1938

WHAT IS Medical Foods

Foods formulated for oral or enteral use under the supervision of a physician and that are intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements are established by medical evaluation. Medical foods must be specially formulated, not naturally occurring, and must provide nutritional requirements that would be impossible for the patient to meet through a normal diet. Examples: food formulated without the amino acid phenylalanine for phenylketonuria, and folic acid, B6, B12 combination products for hyperhomocysteinemia.

Medical Devices Class II

General controls are insufficient to ensure safety and effectiveness and are subject to special controls. Performance standards, postmarket surveillance, patient registries, development and dissemination of guidance documents, recommendations, and other appropriate actions. These devices must meet specific performance standards established by the FDA. Examples: insulin syringes, infusion pumps, thermometers, diagnostic reagents, tampons, and electric heating pads

Drug vs Not a Drug

Has the supplier made a therapeutic or health claim, or a structure/function claim? Therapeutic or health claim: is the article intended to diagnose, cure, mitigate, treat, or prevent a disease? Structure/function claims: is it intended to affect the body structure or function (for articles other than food)? Example: A product that claims to prevent pregnancy is a drug because it intends to affect a function of the body.

WHAT IS Tennessee Definition of Devices

Instruments, apparatus and contrivances, including their components, parts and accessories, intended: -For use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals; or -To affect the structure or any function of the body of humans or other animals; Definition does not include: -when the device is misbranded because the labeling is misleading, or -if there is a guaranty which is false, or -a device that misbrands food, or -a device is not correctly labeled, or -a device used to misbrand cosmetics.

WHICH LAW Also known as the Drug Efficacy Amendment

Kefauver-Harris Amendment of 1962

WHICH LAW Created the Drug Efficacy Study Implementation (DESI).

Kefauver-Harris Amendment of 1962

WHICH LAW Established Good Manufacturing Practices requirements (GMP).

Kefauver-Harris Amendment of 1962

WHICH LAW Required informed consent of research subjects and reporting of adverse drug reactions.

Kefauver-Harris Amendment of 1962

WHICH LAW Required new drugs to be proven effective as well as safe. Made retroactive to all drugs marketed between 1938 and 1962.

Kefauver-Harris Amendment of 1962

WHICH LAW Run efficacy tests on the drugs that were marketed between 1938 and 1962.

Kefauver-Harris Amendment of 1962

WHICH LAW Transferred jurisdiction of prescription drug advertising from the FTC to the FDA.

Kefauver-Harris Amendment of 1962

Pearson vs. Shalala

Manufacturers challenged the FDA's premarket approval requirement for health claims, and the legality of the FDA's procedure for determining "significant scientific agreement". Held: Requirement for premarket approval violated the 1st Amendment, and FDA lacked criteria for determining "significant scientific agreement". Held: The complete suppression of health claims, unless false or misleading, is too restrictive when disclaimers on the label would accomplish the FDA's objectives

WHICH LAW Authorizes FDA to regulate medical devices

Medical Device Amendment Act of 1976 Medical Devices vs Drugs

WHICH LAW Differentiates devices from drugs by defining a device as a product that does not achieve any of its principal intended purposes through chemical action and is not dependent on being metabolized for the achievement of any of its principal intended purposes

Medical Device Amendment Act of 1976 Medical Devices vs Drugs

WHICH LAW established 1-Classification of devices according to their functions 2-Premarket approval (prove safety and efficacy) 3-Establishment of performance standards 4-Conformance with GMP regulations 5-Adherence to record and reporting requirements

Medical Device Amendments of 1976

Rules for Cosmetics

No premarket approval from the FDA Manufacturer does not have to conform to GMP or register with the FDA (registration is voluntary) FDA may remove a cosmetic from the market if it is misbranded, adulterated, or a health hazard Labeling: List of ingredients in descending order of predominance "Fragrances" or "flavors" listed generally Warning labels: Self-pressurized containers If safety has not been determined, must warn Hair dyes with coal tar Must conform to PPPA (some products need to be childproof)

WHICH LAW Mandates nutrition labeling on food products

Nutrition Labeling and Education Act of 1990

WHICH LAW Authorizes health claims on product labeling as long as the claims comply with FDA regulations.

Nutrition Labeling and Education Act of 1990

WHICH LAW Standardized the use of labeling terms with health implications, such as "low fat" and "light"

Nutrition Labeling and Education Act of 1990

WHAT IS Health Claims

Nutrition Labeling and Education Act of 1990 (NLEA): allowed food labeling to contain a health or disease-prevention claim, but only if the FDA had promulgated regulation approving the claim and establishing the conditions under which the claim can be made Dietary Supplement Health and Education Act of 1994: Legally created the category of dietary supplements and significantly altered FDA's authority to regulate them. Permits structure/function claims, claims of general well-being and claims related to a nutrient deficiency disease. FDA Modernization Act of 1997: permitted health claims without the requirement that the FDA must issue a regulation as long as there is "significant scientific agreement" as determined by the FDA.

WHAT is the name of the Legal documents recognized by the US government -Contains monographs of recognized drugs, Includes the drug's chemical characteristics and standards of quality.

Official Compendia of the United States

WHICH Legal documents recognized by the US government said this? "Under the FDCA, a drug recognized in the USP/NF or HPUS must meet all compendium standards or it will be considered misbranded or adulterated unless it states "not USP/NF"

Official Compendia of the United States

WHICH LAW GAVE Exclusive licensing incentives to manufacturers of an orphan drug protection for 7 years against competition from any drug with similar effect

Orphan Drug Act of 1983

WHICH LAW Provides exclusive licensing incentives for manufacturers to develop and market drugs or biological products for the treatment of "rare diseases and conditions".

Orphan Drug Act of 1983

WHICH LAW Provides exclusive licensing incentives for manufacturers to develop and market drugs or biological products for the treatment of "rare diseases and conditions". Drugs developed for diseases affecting fewer than 200,000 Americans.

Orphan Drug Act of 1983

WHAT IS THE Federal Definition of Drug

Part A. Article recognized in the official United States Pharmacopoeia/National Formulary (USP/NF), or official Homeopathic Pharmacopoeia of the United States (HPUS), or any supplements of these references. Part B. Article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals. Part C. Article (other than food) intended to affect the structure or any function of the body of humans or other animals. Part D. Article intended for use as a component of any articles specified in the above but does not include devices or their components, parts, or accessories.

Medical Devices Class I

Pose least potential harm to users General controls are adequate to ensure safety and effectiveness Subject to the provisions for adulteration, misbranding, registration, banned devices, notifications, records and reports, and other general provisions Examples: needles, scissors, examination gloves, stethoscopes, toothbrushes

WHICH LAW Addressed issue of prescription drug diversion from legitimate channels.

Prescription Drug Marketing Act of 1987

WHICH LAW Bans the sale, trade, or purchase of prescription drug samples.

Prescription Drug Marketing Act of 1987

WHICH LAW Specifies precise storage, handling and recordkeeping requirements for prescription drug samples.

Prescription Drug Marketing Act of 1987

WHIH LAW Prohibits, with some exceptions, hospitals and other healthcare entities from reselling their pharmaceutical purchases to other business. Requires the state licensing of prescription drugs produced in the United States

Prescription Drug Marketing Act of 1987

WHICH LAW Prohibited foods and drugs distributed through interstate commerce to be adulterated or misbranded.

Pure Food and Drug Act of 1906

Medical Devices Class III

Requires premarket approval Life supporting or life-sustaining devices, Important in preventing impairment to human health, Presents a potential unreasonable risk of illness or injury, or Insufficient information exists to determine its safety and effectiveness Examples: pacemakers, soft contact lenses, replacement heart valves

WHICH LAW Expedited the premarket device approval process, Premarket notification and approval, Added post-marketing requirements

Safe Medical Devices Act of 1990

FDA Conditions for Making Structure/Function Claims for DS

Seller must have substantiation that they are truthful and not misleading Label of the product must contain the disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." Manufacturer must notify the FDA within 30 days if it makes one of the permitted statements

Structure/Function Claims (Part C)

Structure/function claims appear on the labels of conventional foods and dietary supplements and drugs. The Dietary Supplement Health and Education Act of 1994 (DSHEA) allows: -The use of structure/function claims and Two related types of dietary supplement labeling claims. -Claims of general well-being and claims related to a nutrient deficiency disease. -Structure/function claims may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, for example, "calcium builds strong bones". -In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, "fiber maintains bowel regularity," or "antioxidants maintain cell integrity". -General well-being claims describe general well-being from consumption of a nutrient or dietary ingredient (promotes relaxation, etc.) -Nutrient deficiency disease claims describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), but such a claim must include statement about how widespread the disease is in the United States.

WHICH LAW Establishes two, parallel, mandatory reporting systems for adverse events for dietary supplements and OTCs

The Dietary Supplement and Nonprescription Drug Consumer Protection Act 2006

WHICH LAW Authorizes FDA to ban individuals or firms from participating in the drug approval process if convicted of related felonies. Imposes severe civil penalties for any false statements, bribes, failures to disclose material facts, and other related offenses.

The Generic Drug Enforcement Act of 1992

-Proposed changes to the USP/NF are published in a bimonthly publication called

The Pharmacopoeia Forum (PF)

WHAT IS Federal Definition of Food

The term "food" means articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article.

Safety Issues with Dietary Supplements

To remove dietary supplement from the market, FDA must prove the product is adulterated DSHEA provides that a product is adulterated if it presents a "significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling; and if no conditions of use are recommended or suggested, then under ordinary conditions of use." Dietary Supplement and Nonprescription Drug Protection Act 2006: gave an avenue to report adverse events from dietary supplements and nonprescription drugs.

WHAT IS Special Dietary Foods

Under the FDCA, special dietary foods include, but are not limited to those supplying a special dietary need that exists by reason of a physical, physiological, pathological, or other condition, including but not limited to the condition of disease, convalescence, pregnancy, lactation, infancy, allergic hypersensitivity to food, underweight, overweight, or the need to control the intake of sodium. Examples: infant formulas, artificial sweeteners, and caloric supplements.

Homeopathic Pharmacopoeia of the United States (HPUS) is published by

a private organization

The United States Pharmacopoeia/National Formulary (USP/NF) is published by

a private organization known as the US Pharmacopoeia Convention (USPC).