General Federal Regulation of Drugs Part 1
New Drug
(1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a ''new drug'' if at any time prior to June 25, 1938, it was subject to the Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use.
Color Additive
A product is considered to be adulterated if: It contains an unapproved ____ ____
Food; Drug; Cosmetic; Dietary Supplement; Claims
An Article may be a ____, a ____, a ____ and/or a ____ Depends on distributor's ____
USP; NF: USP; NF; Homeopathic Pharmacopoeia of the US; Official Compendia
Food, Drug & Cosmetic Act of 1938: Recognized the ____ and ____ (now ____/____) and ____, which were privately published, standards of drug quality and drug characteristics, as the "____ ____" of drugs.
FDCA
Food, Drug Cosmetic Act of 1938: Became the backbone of the current ____
Label
Labeling: The information printed by the pharmacist on the prescription ____ for a drug product.
Unsanitary; Poorly
Pure Food and Drug Act of 1906: Concern for the risks to public health and safety associated with ____ and ____ labeled foods and drugs prompted Congress in 1906 to pass the Pure Food and Drug Act.
New Drug
A ____ ____ is defined as any drug in which the composition is not generally recognized
Official Compendium; Official Compendium
A drug or device shall be deemed to be ADULTERATED: b) Strength, quality, or purity differing from ____ ____. If it purports to be or is represented as a drug the name of which is recognized in an ____ ____, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium.
Coloring; Unsafe; Unsafe
A drug or device shall be deemed to be ADULTERATED: or (4) if (A) it bears or contains, for purposes of ____ only, a color additive which is ____ within the meaning of section 379e(a) of this title, or (B) it is a color additive the intended use of which in or on drugs or devices is for purposes of coloring only and is ____ within the meaning of section 379e(a) of this title.
Current Good Manufacturing Practice; Quality; Purity;
A drug or device shall be deemed to be ADULTERATED: or (B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with ____ ____ ____ ____ to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the ____ and ____ characteristics, which it purports or is represented to possess.
Decomposed; Insanitary; Filth
A drug or device shall be deemed to be ADULTERATED: (1) If it consists in whole or in part of any filthy, putrid, or ____ substance; or (2)(A) if it has been prepared, packed, or held under ____ conditions whereby it may have been contaminated with ____, or whereby it may have been rendered injurious to health.
Adulterated
A drug or device shall be deemed to be ____: (1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
Active Drug
A drug or drug product is considered to be MISBRANDED if the labeling: Does not have each ____ ____ ingredient identified;
Active Drug
A drug or drug product is considered to be MISBRANDED if the labeling: Does not include the established name of the ____ ____
Rx Only
A drug or drug product is considered to be MISBRANDED if the labeling: Does not state "____ ____" if the drug is available only by prescription (not the dispensed prescription label).
False; Misleading
A drug or drug product is considered to be MISBRANDED if the labeling: Is ____ or ____
Manufacturer; Packer; Distributor
A drug or drug product is considered to be MISBRANDED if the labeling: Is missing the name or location of the ____, ____ or ____;
Misbranded
A drug or drug product is considered to be ____ if the labeling: - Is false or misleading; - Is missing the name or location of the manufacturer, packer or distributor; - Does not include the established name of the active drug; - Does not have each active drug ingredient identified; - Does not state "Rx Only" if the drug is available only by prescription (not the dispensed prescription label).
Adulterated
A product is considered to be ____ if: - It contains in whole or in part any filth, putrid, or decomposed substance; - It has been prepared, packaged, or held under unsanitary conditions where it may have been contaminated; - It has been manufactured under conditions that do not meet the standards of current Good Manufacturing Practices (cGMP); - It contains an unapproved color additive;
Filth; Putrid; Decomposed
A product is considered to be adulterated if: It contains in whole or in part any ____, ____, or ____ substance;
Current Good Manufacturing Practices (cGMP);
A product is considered to be adulterated if: It has been manufactured under conditions that do not meet the standards of ____
Unsanitary
A product is considered to be adulterated if: It has been prepared, packaged, or held under ____ conditions where it may have been contaminated;
Compendia; Lower
Adulterated, if: It contains a drug not recognized in official ____, but its strength, quality, purity is ____ than listed on the label;
Strength; Purity; Quality
Adulterated, if: It contains a drug recognized in the official compendia, but its ____, ____ or ____ is LOWER than the official standard;
Active Drug
Adulterated, if: It contains any ingredient as a substitute for the ____ ____
Deleterious
Adulterated, if: Its container is composed of a ____ substance that may (leach) into the product contents;
Article
An ____ may be a food, a drug, a cosmetic and/or a dietary supplement Depends on distributor's CLAIMS
Drugs; Foods; Drugs; Cosmetics; Devices
The Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 301 et seq., 52 Stat. 1040 (1938)) currently provides for: - The comprehensive regulation of all ____ introduced into interstate commerce. - The intent of the law is to protect consumers from adulterated or misbranded ____, ____, ____, or ____
Adulterated; Misbranded
The intent of the FDCA is to protect consumers from ____ or ____ foods, drugs, cosmetics, or devices.
Device
The term "____" ... means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is (1) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal 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 any of its principal intended purposes.
National Formulary; US Pharmacopoeia
The term "device" ... means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is (1) recognized in the official ____, or the ____, or any supplement to them,
Diagnosis; Cure; Treatment; Prevention
The term "device" ... means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is (2) intended for use in the ____ of disease or other conditions, or in the ____, mitigation, ____, or ____ of disease, in man or other animals, or
Structure; Function
The term "device" ... means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is (3) intended to affect the ____ or any ____ of the body of man or other animals, and which does not achieve any of its principal 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 any of its principal intended purposes.
Dietary Supplement
The term ''____ ____'' - (1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described here.
Drug
The term ''____'' means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C).
Cosmetic
The term ''____'' means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.
Food
The term ''____'' means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
Body; Component; Soap
The term ''cosmetic'' means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human ____ or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a ____ of any such articles; except that such term shall NOT include ____
Vitamin; Mineral; Herb; Amino Acid; Dietary; Concentrate
The term ''dietary supplement'' - (1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) a ____; (B) a ____; (C) an ____ or other botanical; (D) an ____ ____; (E) a ____ substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a ____, metabolite, constituent, extract, or combination of any ingredient described here.
US Pharmacopoeia; Homeopathic Pharmacopoeia of US; National Formulary
The term ''drug'' means (A) articles recognized in the official ____, official ____, or official ____ or any supplement to any of them; and
Diagnosis; Cure; Treatment; Prevention
The term ''drug'' means (B) articles intended for use in the ____, ____, mitigation, ____, or ____ of disease in man or other animals; and
Structure; Function
The term ''drug'' means (C) articles (other than food) intended to affect the ____ or any ____ of the body of man or other animals; and
Component
The term ''drug'' means (D) articles intended for use as a ____ of any article specified in clause (A), (B), or (C).
Food; Drink; Gum; Components
The term ''food'' means (1) articles used for ____ or ____ for man or other animals, (2) chewing ____, and (3) articles used for ____ of any such article.
Package Liners
The term ''immediate container'' does NOT include ____ ____
Labeling
The term ____ has a broader definition and includes the label, it also applies to the information "accompanying" the drug, such as the package insert.
Label; Package Insert
The term labeling has a broader definition and includes the ____, it also applies to the information "accompanying" the drug, such as the ____ ____
Compendium
USP-NF: The official ____ of the United States
New Drug; Safe; Effected; FDA
Under the FDCA, no ____ ____ may be marketed and sold unless it has been proved both ____ and ____ for its intended use and approved by the federal ____
FDCA
Under the ____, no new drug may be marketed and sold unless it has been proved both safe and effective for its intended use and approved by the federal Food and Drug Administration (FDA).
Federal Food, Drug and Cosmetic Act of 1938 (FDCA)
____ (21 U.S.C. § 301 et seq., 52 Stat. 1040 (1938)) currently provides for: - The comprehensive regulation of all drugs introduced into interstate commerce. - The intent of the law is to protect consumers from adulterated or misbranded foods, drugs, cosmetics, or devices.
Misbranded
____ if the labeling: - Does not contain a precautionary statement for a drug product that is subject to deterioration; - Is missing the quantity of the container contents (quantity, weight, or fluid volume); - Has inadequate directions for use of nonprescription drugs or does not include appropriate warnings required to protect those using the medication or packaging; - Is not according to USP/NF specifications; - Offers the sale of a drug under the name of a different drug.
Adulterated
____, if: - It contains a drug recognized in the official compendia, but its strength, purity or quality is lower than the official standard; - Its container is composed of a deleterious substance that may (leach) into the product contents; - It contains a drug not recognized in official compendia, but its strength, quality, purity is lower tha listed on the label; - It contains any ingredient as a substitute for the active drug.
Grandfather Clause/Exemption
____: Drugs marketed before 1938 were not subject to review or NDA requirements. E.g., Levothyroxine, digoxin, NTG, phenobarb
USP-NF
____: The official compendium of the United States
It could be ....
Can a cosmetic become a drug?
Therapeutic; Structure; Function
Can a cosmetic become a drug? It could be .... A cosmetic may become a drug if its manufacturer promotes it for a ____ purpose (article intended to diagnose, cure, mitigate, treat, or prevent a disease, or (for articles other than food) was it intended to affect the body ____ or ____), despite the product chemistry.
Ignorant, Unthinking and Credulous
Can a cosmetic become a drug? It could be .... E.g., manufacturer's advertisements claimed that a lotion would "lift out puffs" or give a "facelift without surgery." FDA sued manufacturer. The Court applied the standard of what an "____" consumer would believe. On the basis of this standard and the manufacturer's claims (i.e., intended to affect the body structure or function), the court found that the lotion was a drug. United States v. An Article ... Consisting of 216 Cartoned Bottles, More or Less, "Sudden Change," 409 F. 2d 734 (2nd Cir. 1969).
"It depends" ...
Can a food be a drug?
C; Therapeutic; Health; B;
Can a food be a drug? "It depends" ... Although EXCEPTED under part ____ of the drug definition, almost any food might be considered a drug if a ____ or ____ claim is made for it under part ____ of the drug definition, i.e., intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Misbranded
Can a food be a drug? "It depends" ... E.g., General Mills labeled its Cheerios Toasted Whole Grain Oat Cereal with the claims: "You can Lower Your Cholesterol 4% in 6 weeks" and "Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4%?" The FDA issued a warning letter to General Mills in May 2009, contending that these claims indicate that Cheerios is intended for use in lowering cholesterol, and therefore preventing and treating the disease of hypercholesterolemia, thus making Cheerios an unapproved new drug and ____
Efficacy
Congress amended the Pure Food and Drug Act in 1912 to prohibit false and fraudulent ____ claims.
Food
Dietary Supplement: Except for purposes of paragraph (g), a dietary supplement shall be deemed to be a ____ within the meaning of this chapter.
Dietary Supplement Health Education Act (DSHEA)
Dietary Supplements are regulated under the??
Effective; Safe
Food Drug & Cosmetic Act of 1938: INITIALLY, did not require drugs to be "____" for intended purposes (that came later), just ____
Food Drugs Cosmetics Devices Dietary Supplements Soap (Depending on the intended purpose/claim)
Food Drug & Cosmetic Act of 1938: What are the 6 articles regulated by the FDCA??
Therapeutic; Health; Structure; Function
Food Drug Cosmetic Act of 1938: The crucial issue in the determination of whether a product is a drug centers on whether the supplier made a ____ or ____ claim, or a ____/ ____ claim.
Drug
Food Drug Cosmetic Act of 1938: If therapeutic or structure/ function claims are made by the supplier, an article is a ____, no matter what disclaimers may be included in the labeling
Diagnose; Cure; Treat; Prevent; Structure; Function
Food Drug Cosmetic Act of 1938: The crucial issue in the determination of whether a product is a drug centers on whether the supplier made a therapeutic or health claim, or a structure/ function claim. In other words, was the article intended to ____, ____, mitigate, ____, or ____ a disease, or (for articles other than food) was it intended to affect the body ____ or ____?
Supplier's; Purchaser's
Food Drug Cosmetic Act of 1938: ____ intended use of the product is what is IMPORTANT, not the ____ intended use
Dietary Supplements; Food Ingredients
Food, Drug & Cosmetic Act of 1938: USP-NF Also sets standards for ____ and ____
Compounding; Manufacturing
Food, Drug & Cosmetic Act of 1938: USP-NF General chapters elaborate on ____ and ____ standards (among other things)
New Drug Application/Approval Process (NDA)
Food, Drug Cosmetic Act of 1938: Established the ____
FDA
Food, Drug Cosmetic Act of 1938: Established the ____ - Administrative Agency within US DHHS
Cosmetics; Medical Devices; Food; Drugs
Food, Drug Cosmetic Act of 1938: FDCA applies to ____ and ____ as well as ____ and ____
Amended
Food, Drug Cosmetic Act of 1938: Has been ____ many, many times, typically in response to a health crises.
New Drug; Safe
Food, Drug Cosmetic Act of 1938: No "____" could be introduced into interstate commerce unless first proven "____" when used according to directions on the label.
Warning
Food, Drug Cosmetic Act of 1938: Required ____ labels for habit-forming drugs.
Directions for Use
Food, Drug Cosmetic Act of 1938: Required medication labels to have "adequate ____" unless dispensed pursuant to prescription from state-authorized prescriber.
Interstate Commerce
Generally, it is unlawful to introduce into ____ ____ an article (food, drug, cosmetic or device) that is: ADULTERATED, or MISBRANDED
Crime; 1 Year; 1,000; 3 Years; 10,000
Generally, it is unlawful to introduce into interstate commerce an article (food, drug, cosmetic or device) that is: ADULTERATED, or MISBRANDED It's a ____! The FDCA provides that any violator shall be imprisoned for not more than ____, fined not more than $ ____, or both. If the violator commits a second offense of the act or commits a violation with the intent to defraud or mislead, the violator could be imprisoned for up to ____ and/ or fined up to $ ____
Adulterated; Misbranded
Generally, it is unlawful to introduce into interstate commerce an article (food, drug, cosmetic or device) that is: ____, or ____
1938
Grandfather Clause/Exemption: Drugs marketed before ____ were not subject to review or NDA requirements. E.g., Levothyroxine, digoxin, NTG, phenobarb
Pure Food and Drug Act of 1906
Historical Prospective - ____ Concern for the risks to public health and safety associated with unsanitary and poorly labeled foods and drugs prompted Congress in 1906 to pass the Pure Food and Drug Act. The law prohibited the adulteration and misbranding of foods and drugs in interstate commerce. No requirements for ingredients or new drug approval.
Drug
If something is included in the official compendium, it is considered a ____
Food, Drug Cosmetic Act of 1938
Impetus: In 1937, S. E. Massengill Company created a preparation of sulfanilamide using diethylene glycol (DEG) as a solvent, and called the preparation "Elixir Sulfanilamide." DEG is poisonous to humans and other mammals. Harold Watkins, the company's chief pharmacist and chemist, was not aware of this. 107 deaths resulted. Watkins committed suicide pending trial. Massengill paid a fine for using the word "elixir" when the product had no alcohol in it. Because of this situation, the ____ was made
Immediate Container
Label: Refers to written, printed or graphic matter on the "____ ____" of a drug product. If there is an outside package, any word, statement, or other information present on the immediate container must appear on the outside package.
Label; Outside Package; Labels
Labeling: Refers to the information printed on the ____ and the ____ ____ of a drug product. Refers to all ____ and other written, printed, or graphic matter either on the product, its container, its wrapper, or accompanying the product.
Precautionary
MISBRANDED if the labeling: Does not contain a ____ statement for a drug product that is subject to deterioration;
Directions; Warnings
MISBRANDED if the labeling: Has inadequate ____ for use of nonprescription drugs or does not include appropriate ____ required to protect those using the medication or packaging;
Quantity; Quantity
MISBRANDED if the labeling: Is missing the ____ of the container contents (____, weight, or fluid volume);
USP/NF
MISBRANDED if the labeling: Is not according to ____ specifications;
Different
MISBRANDED if the labeling: Offers the sale of a drug under the name of a ____ drug.
Not Generally Recognized; Safe; Effective
New Drug: (1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is ____ ____ ____, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as ____ and ____ for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a ''new drug'' if at any time prior to June 25, 1938, it was subject to the Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use.
Ingredients; New Drug
Pure Food and Drug Act of 1906: No requirements for ____ or ____ approval.
Adulteration; Misbranding; Foods; Drugs
Pure Food and Drug Act of 1906: The law prohibited the ____ and ____ of ____ and ____ in interstate commerce.
Label
Refers to written, printed or graphic matter on the "immediate container" of a drug product. If there is an outside package, any word, statement, or other information present on the immediate container must appear on the outside package.