FEDERAL REGULATIONS OF MEDICATIONS

1
FEDERAL REGULATIONS OF MEDICATIONS

• Food, Drug and Cosmetic Act
• Protect consumers from adulterated and misbranded
  foods, drugs, cosmetics, or devices

2
FOOD

• Articles used for food and drink
• Chewing gum
• Articles used for components of any such article

3
DRUG

• Listed in USP, Homoeopathic Pharmacopeia of US,
  NF or supplements
• Intended for use in
• Diagnosis
• Cure
• Mitigation
• Treatment
• Prevention

4
DRUG (cont)

• Intended to affect structure or function of body
• Intended for use as a component of the others
• Achieve intended purpose through chemical action

5
DEVICE

• Listed in USP, NF, or supplements
• Intended
• Diagnosis of disease or other conditions
• Cure
• Mitigation
• Treatment
• Prevention

6
DEVICE (cont)

• Intended to affect structure or function
• Does not achieve primary intended purposes
  through chemical action and is not dependent on
  being metabolized

7
LABEL

• Written, printed, or graphic matter upon the
  immediate container of any article

8
LABELING

• All labels
• Other written, printed, or graphic matters upon
  article or any of its containers or wrappers
• Material accompanying such article

9
ADULTERATION

• Consists of any filthy, putrid, or decomposed
  substance
• Prepared or held under unsanitary conditions
• Does not meet CGMP
• Varies from USP standards
• Contains unapproved color additive
• Container leaks or causes drug decomposition

10
MISBRANDING

• Labeling is false or misleading
• Drug is subject to deterioration, unless label
  states precautions
• Drug is subject to but not packaged according to
  Poison Packaging Act
• Dispensing of non FDA approved drug
• Dispense Rx drugs or refill without authorization
  or prescription

11
NEW DRUG APPROVAL

• New drug
• NDA approved by FDA
• Reports showing drug safety and efficacy
• Drugs components and composition
• Methods, facilities, and controls used
• Samples of the drug and its components
• Proposed labeling of the drug

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NEW DRUG TESTING (IND)

• Phase I (to detect adverse effects)
• Small number of people
• Examines
• Toxicity
• Metabolism
• Bioavailability
• Elimination
• Other pharmacologic activities

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NEW DRUG TESTING (Cont)

• Phase II (determine efficacy and dosages)
• Patients with the disease
• Continue pharmacological testing to ensure safety

14
NEW DRUG TESTING (Cont)

• Phase III
• Given to large numbers of patients to further
  determine safety and efficacy
• If successful may submit NDA

15
OTC LABEL

• 1. The name of the product
• 2. The name and address of the manufacturer,
  packer, or distributor
• 3. The net contents of the package
• 4. The established name of all active
  ingredients, and the quantity of certain other
  ingredients whether active or not
• 5. The name of any habit-forming drug contained
  in the preparation
• 6. Cautions and warnings needed for the
  protection of the user and
• 7. Adequate directions for safe and effective use.

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Rx DRUG

• 1 A statement of the drugs identity in terms of
  its established name and quantity and portion of
  each active ingredient.
• 2 A declaration of net quantity.
• 3 A statement of the usual dosage.
• 4 The federal caution legend.
• 5 The route of administration if it is not for
  oral use.
• 6 If it is a habit forming drug, the federal
  warning, Warning May be habit forming.
• 7 If other than oral use, the names of all
  inactive ingredients- exceptions are made for
  flavorings, perfumes, and color additives.
• 8 An identifying lot or control number.
• 9 A statement to the pharmacist specifying the
  type of container to be used in dispensing.
• 10 The name and place of business of the
  manufacturer, packer, or distributor.
• 11 The expiration date unless exempted.

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Rx DRUG LABELING

• 1 Description
• 2 Clinical pharmacology
• 3 Indications and usage
• 4 Contraindications
• 5 Warnings
• 6 Precautions
• 7 Adverse reactions
• 8 Drug abuse and dependence
• 9 Overdosage
• 10 Dosage and administration
• 11 How supplied

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DURHAM-HUMPHREY AMENDMENT OF 1951

• Only upon the written prescription of a physician
  licensed by law to administer such drugs
• Upon the physicians oral prescription, which is
  reduced promptly to writing and filled by the
  pharmacist
• By refilling a written or oral prescription if
  the refill is authorized by the prescriber either
  on the original prescription or orally and then
  reduced to writing and filled by the pharmacist
  or
• By administration (dispensing) directly by the
  physician.

19
KEFAUVER-HARRIS AMENDMENTS OF 1962

• Before marketing any new drug, manufacturers were
  required to supply a) proof of safety, and b)
  proof of effectiveness.
• Current Good Manufacturing Practices, the
  so-called CGMP, were established, and if a
  manufacturer produced a drug without adhering to
  such practices, that drug was considered
  adulterated.
• Prescription drug advertising was placed under
  the supervision of the FDA, while the Federal
  Trade Commission (FTC) continued to supervise the
  advertising of OTC items.
• The amendments established a procedure for new
  drug applications and for investigational drug
  procedures which required assurances of the
  informed consent of the research subjects and
  required reporting of adverse drug reactions.
  Qualifications of drug investigators were subject
  to review.

20
MEDICAL DEVICE AMENDMENT OF 1976

• All medical devices in Classes I, II, or III, on
  the basis of the risk
• Class III devices are subject to pre-market
  approval.

21
ORPHAN DRUG ACT OF 1983

• Provides tax incentives and a limited exclusive
  license (7 years) to manufacturers of drugs for
  rare diseases or conditions
• A rare disease or condition is one that affects
  less than 200,000 persons in the U. S
• One that affects more than 200,000 persons in the
  U. S. and for which there is no reasonable
  expectation of recovering the development costs

22
DRUG PRICE COMPETITION AND PATENT TERM
RESTORATION ACT OF 1984

• Extended the ANDA process to include generic
  versions of all post-1962 approved drugs, except
  antibiotics, which already had a generic approval
  process in place
• Act permits extension of patent life

23
PRESCRIPTION DRUG MARKETING ACT OF 1987

• Reduce the potential public health risks that may
  result from diversion of prescription drugs from
  legitimate commercial channels
• States license wholesale distributors
• The reimportation of prescription drugs produced
  in the U. S. is banned
• It also bans sale, trade or purchase of drug
  samples and the trafficking in and counterfeiting
  of drug coupons