Transcript federal laws

FEDERAL LAWS
LAWS, RULES, AND
REGULATIONS
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Pure Food and Drug Act of 1906
Food, Drug and Cosmetic Act of 1938
Durham-Humphrey Amendment of 1951
Kefauver-Harris Amendment of 1962
Orphan Drug Act of 1983
Drug Price Competition Act of 1984
Prescription Drug Marketing Act of 1987
FDA Modernization Act of 1997
BRING NEW DRUG TO THE
MARKET
Investigational New Drug Application (IND)
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Phase 1
(small group of healthy individuals, access safety of drug in
humans)
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Phase 2
(Larger group of patients that have the disease or symptoms of
conditions, obtain dosage and adverse effects infor.)
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Phase 3
(Larger group of patients, mostly double blind study that compared
drug’s effectiveness and controlled group {placebo})
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New Drug Application (NDA) Process
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Phase 4
(Post-marketing surveillance of the drug)
• Fast Tract Products
Serious or Life-threatening conditions
• Abbreviated New Drug Application (ANDA)
Generic company submitted an ANDA
• Supplemental New Drug Application (SNDA)
Manufacturer submitted changes
• Orphan Drugs
Orphan Drugs Act of 1983
Rare disease (<200,000 persons in U.S)
NAMING NEW DRUG
Nonproprietary or generic name
designated by the United States
Adopted Names Council (USAN).
However, the Secretary of Human
Health Services (HHS) must grant the
final approval of any drug name.
NATIONAL DRUG CODE (NDC)
1234
(manufacturer)
5678
90
(ID of drug) (package size)
The STEPS Program for
Thalidomide (Thalomid)
STEPS – System for Thalidomide Education and
Prescribing Safety
• Females must undergo pregnancy test
• Males must use condoms
• All prescribers and pharmacies must registered
• Monitored by mandatory patient surveys
• Up to 28-day supply with no refill
• Written Rx must be filled within 7 days
SMART Program for Isotretinoin
(Accutane)
SMART – System to Manage Accutane
Related Teratogenicity
“Accutane Qualification Sticker” (yellow)
• Up to 30 days supply
• No refill
• Must be filled within 7 days (women)
• All Rxs must bear “sticker” (men and
women)
DRUG RECALLS
Class I
Product may cause serious, adverse health
consequences include death
Class II
Product may cause temporary or reversible effects
but serious adverse effect is remote
Class III
Product is unlikely to cause any adverse health
consequences
PRESCRIPTION OWNERSHIP
Once a prescription has been filled
and dispensed, the prescription is
legally owed by the pharmacy
Expiration date vs. Beyond-use-date
Expiration date – dating required on
manufacturer’s containers
Beyond-use-date – dating of drug products
that are dispensed by pharmacists.
EXPIRATION DATE FOR
COMMERCIAL DRUG PRODUCTS
Expiration date of “June 2005” indicates that
the product will remain within USP/NF
specifications at least through June 30,
2005.
Homeopathic products are exempted from
the requirement of an expiration dating.
EXPIRATION DATE FOR A UNIT
DOSE PACKAGE
Use the shorter of the two methods:
• 6 months maximum or
• 25% of remaining time on original
package
REFILL CONTAINERS
• Body and closure of plastic container units
must be replace
• Glass body may be reused
POISON PREVENTION
PACKAGING ACT (PPPA)
• To protect children < 5 years old
• Only patients may provide a “blanket
waiver” the pharmacist.
• Drugs are administered by health care
professionals
EXEMPT FROM THE PPPA
• SL Nitroglycerin tablets
• SL and chewable ISDN (10mg or less)
• Aspirin and Acetaminophen effervescent tablets
or granules
• Oral Contraceptive in memory-aid packages
• Unit-dose packaging of Potassium
• Sodium fluoride (NTE 264mg/package)
• Anhydrous cholestyramine and Colestipol
packages
• Aerosol containers for inhalation therapy
PPPA for IRON-CONTAINING
PROUCTS
• Products containing > 30mg of elemental
Iron must be packaged in unit dose
containers
• Packages containing > 250mg of
elemental Iron must be child-resistant
Patient Package Inserts (PPIs)
PPIs must be provided to patients receiving:
Accutane
HMG-CoA reductase inhibitors
Estrogen or Progesterone-containing
products
Drug Product Substitution
The originally prescribed drug and the
substituted drug must be
PHARMACEUTICLLY equivalent
• Same active ingredient
• Same dosage form
• Same route of administration
• Same strength and concentration
REFERENCE SOURCES
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The Orange Book
USP/DI volume III
Facts and Comparisons
FDA’s internet Web site:
http://www.fda.gov/cder/ob/default.htm
Classification of Substitution
• “A” rated products
Bioequivalent and thus “therapeutically
equilavent” to the reference product and
may be substituted for one another
• “B” rated pruducts
NOT bioequivalent and may NOT
substitute for one another
LAWS AND REGULATIONS
• OBRA 90 patients counseling
Omnibus Budget Reconciliation Act
• HIPPA privacy of patient’s medical records
Health Insurance Portability and
Accountability Act
CONTROLLED SUBSTANCES
• Controlled Substances Act (CSA)
• The Administrator of Drug Enforcement
Agency (DEA) delegated authority under
the Act by the Attorney General
APPLICATION OF
REGISTRATION
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Pharmacies – Form 224
Manufacturers or Researchers – Form 225
Narcotic Treatment Programs – Form 363
Purchasing and Transferring – Form 222
Theft or Loss – Form 106
FLORIDA STATUTES
• Chapter 465 – Board of Pharmacy
• Chapter 893 – Controlled Substances
CHAPTER 465
• # of pharmacist on board of pharmacy
• # years per term
• Renewal of pharmacy license
# CE
How often renewal license
• Pharmacy intern
• Pharmacy technician
CHAPTER 893
• Drugs in each Schedules
Schedule C-I
Schedule C-II
Schedule C-III
Schedule C-IV
Schedule CV
p. 247 Rx Prep Handbook
FLORIDA NEGATIVE DRUG
FORMULARY
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Digitoxin
Conjugated Estrogen
Dicumarol
Chlorpromazine (Solid Oral Dosage Form)
Theophylline (Controlled Release)
Levothyroxine Sodium
Pancrelipase (Oral Dosage Forms)