FEDERAL LAWS

1. FEDERAL LAWS

2. LAWS, RULES, AND REGULATIONS • 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

3. BRING NEW DRUG TO THE MARKET

5. 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)

6. 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.

7. NATIONAL DRUG CODE (NDC) 1234 5678 90 (manufacturer) (ID of drug) (package size)

8. 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

9. 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)

10. DRUG RECALLS

11. PRESCRIPTION OWNERSHIP Once a prescription has been filled and dispensed, the prescription is legally owed by the pharmacy

12. 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.

13. 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.

14. 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

15. REFILL CONTAINERS • Body and closure of plastic container units must be replace • Glass body may be reused

16. 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

17. 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

18. 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

19. Patient Package Inserts (PPIs) PPIs must be provided to patients receiving: Accutane HMG-CoA reductase inhibitors Estrogen or Progesterone-containing products

20. 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

21. REFERENCE SOURCES • The Orange Book • USP/DI volume III • Facts and Comparisons • FDA’s internet Web site: http://www.fda.gov/cder/ob/default.htm

22. 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

23. LAWS AND REGULATIONS • OBRA 90 patients counseling Omnibus Budget Reconciliation Act • HIPPA privacy of patient’s medical records Health Insurance Portability and Accountability Act

24. CONTROLLED SUBSTANCES • Controlled Substances Act (CSA) • The Administrator of Drug Enforcement Agency (DEA) delegated authority under the Act by the Attorney General

25. APPLICATION OF REGISTRATION • Pharmacies – Form 224 • Manufacturers or Researchers – Form 225 • Narcotic Treatment Programs – Form 363 • Purchasing and Transferring – Form 222 • Theft or Loss – Form 106

26. FLORIDA STATUTES • Chapter 465 – Board of Pharmacy • Chapter 893 – Controlled Substances

27. CHAPTER 465 • # of pharmacist on board of pharmacy • # years per term • Renewal of pharmacy license # CE How often renewal license • Pharmacy intern • Pharmacy technician

28. 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

29. FLORIDA NEGATIVE DRUG FORMULARY • Digitoxin • Conjugated Estrogen • Dicumarol • Chlorpromazine (Solid Oral Dosage Form) • Theophylline (Controlled Release) • Levothyroxine Sodium • Pancrelipase (Oral Dosage Forms)