FEDERAL LAWS LAWS RULES AND REGULATIONS Pure Food

FEDERAL LAWS

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

BRING NEW DRUG TO THE MARKET Investigational New Drug Application (IND) Phase 1 (small group of healthy individuals, access safety of drug in humans) Phase 2 (Larger group of patients that have the disease or symptoms of conditions, obtain dosage and adverse effects infor. ) Phase 3 (Larger group of patients, mostly double blind study that compared drug’s effectiveness and controlled group {placebo})

New Drug Application (NDA) Process 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 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 (10 mg or less) • Aspirin and Acetaminophen effervescent tablets or granules • Oral Contraceptive in memory-aid packages • Unit-dose packaging of Potassium • Sodium fluoride (NTE 264 mg/package) • Anhydrous cholestyramine and Colestipol packages • Aerosol containers for inhalation therapy

PPPA for IRON-CONTAINING PROUCTS • Products containing > 30 mg of elemental Iron must be packaged in unit dose containers • Packages containing > 250 mg of elemental Iron must be child-resistant

Patient Package Inserts (PPIs) PPIs must be provided to patients receiving: Accutane HMG-Co. A 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 • • 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 • • • 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-III Schedule C-IV Schedule CV p. 247 Rx Prep Handbook

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