Exam 1 - Lecture 1 Flashcards
Time Line of Federal Laws & Regulations
1906 - Pure Food and Drug Act
1938 - FD&C Act
1951 - Durham-Humphrey Amendment
1962 - Kefauver-Harris Amendement
1976 - Medical Device Amendment
1983 - Orphan Drug Act
1984 - Drug Price Competition and Patent Term Restoration Act
1987 - Prescription Drug Marketing Act
1994 - Dietary supplement Health and Education Act
2013- Drug Quality and Security Act (Title I compounding & Title II supply chain security)
Pure Food and Drug Act of 1906
- Prohibited the adulteration and misbranding of foods and drugs in interstate commerce
- Required drugs to meet standards- USP/NF
- Misbranding provision only prevented false claims regarding the drug’s identity (strength, quality, and purity) but not false or misleading efficacy claims.
- Did not give the FDA authority to ban unsafe drugs
FD&C Act
- Prompted by the Sulfanilamide elixir tragedy of 1937
- No New Drug can be approved until proven safe for use under the conditions described on the label and approved by the FDA
- Expanded definitions of misbranding and adulteration
- Required that labels must contain adequate directions for use and warning about the habit-forming properties of certain drugs
- Expanded law to cover cosmetics
Durham-Humphrey Amendment of 1951
- established two classes of drugs: prescription and OTC. (legend & non legend)
- amended the FD&C Act of 1938 provided that prescription drug products labels need not contain adequate directions for use as long as they contain “caution: federal law prohibits dispensing w/o a prescription”(Rx only)
- Allowed verbal prescriptions over phone and refills called in from physician’s office
Kefauver-Harris Amendment of 1962
added the efficacy requirement for drug products, which was made retroactive to 1938. Drug products marketed prior to 1938 remained exempted.
Medical Device Amendment of 1976
provide for more extensive regulation and administrative authority regarding safety and efficacy of medical devices.
Orphan Drug Act of 1983
provides incentives for manufacturers to develop and market drugs and biological for the treatment of rare diseases or conditions
Drug Price Competition and Patent Term Restoration Act of 1984
- Also known as Waxman-Hatch Amendment of 1984
- Facilitated approval process of generic drug while affording patent extensions to innovator drug products
- Created automatic approval for generic drugs by eliminating submission to FDA
- allowed for greater generic competition
Prescription Drug Marketing Act of 1987
- established requirements for prescription drug sample distributions and prohibits the resale of pharmaceutical by hospitals and other healthcare entities to other businesses
Dietary Supplement Health and Education Act of 1994 (DSHEA)
- FDA must regulate Dietary Supplements as food rather than drugs
- FDA cant require pre-market approval for supplements
- FDA required to prove that a dietary supplement is unsafe before removing from market
Rational for Federal Drug regulation?
Protection of the public against adulterer and misbranded drug products
Functions of FDA….
Rulemaking
Issue guidance documents
Incorporate advice from standing advisory committees of outside experts
Food and Drug Administration Info
- Under Department of Health and Human Services
- Lead by a Commissioner, appointed by President and confirmation by Senate
- Administrative agency w/ authority to oversee the safety of food, drug and cosmetics
- Rulemaking authority, develops regulations based on laws set forth in the FD&C Act
What is a drug?
(A) recognized by United States Pharmacopoeia (USP), official Homoeopathic Pharmacopoeia of the United States, or official National Formulary (NF)
(B) intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease
(C) (Non-food) intended to affect structure or function of human body/animals
(D) intended for use as a component of A, B, or C above
What is a Food?
(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.
What are Cosmetics?
(1) 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) intended for use as a component of any such articles; except that such term shall not include soap.
What is a Device?
an instrument, apparatus, implement, machine, implant or other related article which is:
• Recognized in the USP/NF;
• Intended for diagnosis, cure, treatment or prevention; or
• Intended to affect the structure of human or animal body, and
which does not achieve its primary intended purpose by chemical action and is not dependent on metabolism to achieve its primary intended purpose.
What is a Dietary Supplement?
is 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 in clause (A), (B), (C), (D), or (E)
DSHEA permits four types of nutritional support claims, these are….
- Benefiting a classical nutrient deficiency disease
- Describing role of the DS in affecting the structure/function of the body
- Characterizing the mechanism by which a DS acts to maintain the structure or function
- Statements of general well-being
- Must be substantiated as truthful and not misleading*
- Label must contain disclaimer*
When does DSHEA permit health claims?
- if either FDA approves the claim by regulation or by the significant scientific agreement test
What did Pearson v Shalala achieve?
- Supplement manufacturers could make health claims not approved by the FDA, provided they are not false or misleading and accompanied by a disclaimer
DSHEA will exclude an article as a Dietary Supplement if it….
was approved as a drug prior to being marketed as a Dietary Supplement
When can FDA remove a DS?
only on the basis that the product is adulterated, defined as presenting “significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling.”
Which act requires manufactures to report serious adverse effects?
The Dietary Supplement and Nonprescription Drug Consumer Protection Act
The United States Pharmacopeia (USP)
Sets uniform standards
works closely with FDA, but private organization
The Homeopathic Pharmacopeia of U.S (HPUS)
Published standards for homeopathy products by the HPUS
If drug recognized in USP/HPUS, product must meet all standards of the compendia
Kefauver-Harris Amendment 1962 did 4 things
- Required drugs to be effective + safe
- Established GMP requirement
- Oversight of drug Ads from FTC -> FDA
- Clinical trials require informed consent and ADR reporting
Current good manufacturing practice (CGMP)
- Drug safe + meet quality/purity standards
- proper design, monitoring, control of manufacturing processes
- manufacturers must be registered with FDA and inspected once every 2 years
- non-compliance with CGMP can cause FDA to consider drug adulterated = recall/seizure/ or litigation of drug
Consumer Product Tampering (Federal Anti-Tampering Act)
- Federal offense to tamper with consumer products
2. FDA req some OTC/cosmetics/devices have tamper resistant packaging
Misbranding - 21 U.S.C S 352
Label or labeling is…
False/misleading
doesn’t include req elements
not prominently displayed
imitation of another drug
packaging doesn’t confirm to Poison Prevention Packaging Act 1970
Label
is a display of written, printed, or graphic matter upon the immediate container of any article (i.e. on the outside container or wrapper)
Labels are approved by the FDA
*Label is much narrower term than labeling
Labeling
means all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers or accompanying such article.
Adequate Directions for use means….
directions under which the layman can use a drug safety and for the purposes for which its intended
Adequate labeling must include….
Quantity/Dosage for each intended use and for persons of different ages/physical conditions
frequency of admin or application
Duration of use
time of admin or use
Route of admin
Necessary prep instructions (shake well)
Are prescription drugs exempt from the “adequate direction for use” requirement?
Yes, but they must meet “adequate information for use”
Adequate information for use includes….
indications
side effects
Dosages
Routes, methods and frequency and duration of admin
other warnings/precautions required to administer, prescribe, dispense the drug safely
OTC must display the following prominently
o Identity, including established name
o Name and address of manufacturer, packer, and distributor
o Cautions and warning to protect the consumer (see drug panel below)
o “Adequate Directions for Use”
What does Drugs Fact Panel need to include?
o Active ingredients, including dosage unit and quantity per unit
o Purpose
o Uses
o Directions
o Inactive ingredients (alphabetical order)
o Telephone Number for Consumer Questions
Prescription Drug Labels and Labeling requirements
o Name and address of manufacturer, packer, and distributor
o Established name of drug product
o Active ingredients, including quantity and proportion of each
o Inactive Ingredient Name(s) (w/ some exception) if not oral
o Statement of identity (generic and proprietary names)
o Statement of recommended or usual dosage or reference to package insert
o Quantity- Weight and Measure (e.g. 75mg)
o Quantity- Container (e.g. #100 capsules)
o Route of administration (except if oral)
o Lot or control #
o Expiration date (unless exempted)
o “Rx” only or Caution: “Federal law prohibits dispensing without a prescription”
o Direction to RPh regarding container type for dispensing (e.g. “light resistance bottle”)
FDA compliance document will list…
the required label elements for the unit dose container…includes the following
o Established drug name of drug
o Quantity of active ingredient per dosage unit
o Expiration date
o Lot or control #
o Name and address of manufacturer, packer, and distributor (The guidance contains additional requirements for more than one dosage unit per unit dose container and requirements for the outer package)
o The number of dosage units contained, if more than one dosage, and the strength per dosage unit
o The controlled substance symbol if required by the DEA
o The statement “May be Habit Forming” where applicable*
Package Insert Info
- intended to be read by HCP
- pamphleted must accompany a drug product
- container scientific and medical info needed for safe/effective use of the drug
Recalls can be….
- Voluntary by manufacturer
- requested by FDA
- Mandated by FDA
Which four products does FDA have mandatory recall authority?
- infant formula
- Medical devices
- biologic products
- Tobacco products
Class I recall
Reasonable probability that product will cause serious adverse health effects or death
Class II recall
Product may cause temporary or medically reversible adverse health effects, but serious adverse effects are remote
Class III recall
Product unlikely to cause adverse health effects
Black Box warning
- FDA may require it
- warning for drugs that may lead to death or serious injury
- maybe req during NDA review/approval process if risks known
- warning in prominently displayed box
Pregnancy warnings
Used to be A/B/C/X
Drugs approved after 6/30/2015 have new system
New pregnancy warning system requires labeling for…
- Pregnancy
- Lactation
- Female and Male reproductive potential
Pregnancy and lactation subsections must include - Risk summary/Clinical Considerations/ Data
National Drug Code
10 digit code
first 4 = manufacturer (ie Teva)
2nd 4 = product (Prozac 20mg tab)
last 2 = package size (100 ct)
