Pharmacy Practice (78%)
Pharmacist Legal Responsibilities
Acquisition and distribution requirements
Legal requirements for prescription/drug orders
Procedures to dispense prescriptions including controlled substances
OBRA 90 requirements
Distribution and/or dispensing of nonprescription products including controlled substances.
Recordkeeping and patient confidentiality
Licensure, Regulation, Certification, and Operation Requirements (17%)
Qualifications, procedures, internship requirements, etc
Requirements and procedures for licensing/permitting pharmacies
Operational requirements such as equipment, storage, security, advertising, signage, etc
Regulatory Structure and Terms (5%)
Purpose of and terms and conditions found in laws and regulations
Authority, responsibilities and operation of regulatory agencies
***Best answer is the state-specific answer (even if Federal Law is more stringent in that example) FLORIDA LAW RUNS VERY CLOSE TO FEDERAL LAW.
90 Questions60 count30 are pre-tests75 is passing scaled score not %
Federal v. State Law
No distinction is made on the exam b/w federal and state jurisprudence questions. You are to answer each question in terms of the prevailing laws of the state in which you are seeking licensure.
Federal and Florida Pharmacy Law Review
Federal Food, Drug and Cosmetic Act (FDCA) and Poison Prevention Packaging Act (PPA) Historically, laws and actions are responses to a crisis.
I. Federal Food Drug and Cosmetic Act (FDCA) & Major Amendments A. Food, Drug and Cosmetic Act of 1938
1. Following deaths caused by sulfanilamide elixir in 1937, Congress passed the first legislation that required new drugs to be proven safe prior to marketing 2. Established the FDA and is the primary federal law dealing with food, drug cosmetic and medical device safety today (with many amendments). B. Durham – Humphrey Amendment of 1951
1. Established 2 classes of drugs: prescription and OTC
Note: Certain products in the same drug class may be either prescription or nonprescription depending on the product. For example, most insulin products are nonprescription, however certain newer insulin products such as Lantus and Humalog are prescription only products (IBU; insulin relates to strength) 2. Authorized verbal prescription and prescription refills C. Kefauver – Harris Amendments of 1962
1. Required new drugs be proven safe and effective for claimed use. 2. Increased safety requirements and established good manufacturing practices (GMPs) for manufacturing. 3. Gave FDA jurisdiction over prescription drug advertising. D. Medical Device Admendment of 1976
1. Assures safety and efficacy of medical devices and certain diagnostic and laboratory products. 2. Upgraded FDA’s regulatory authority over medical devices. E. Orphan Drug Act of 1983
1. Gave incentive to manufacturers to develop drugs to treat rare diseases. 2. Rare diseases defined as one that affects less than 200,000 people. F. Drug Price Competition and Patent Term Restoration Act of 1984 1. Made it easier for generic manufacturers to get products approved “bioequivalence” to pioneer drug. 2. Provided patent life extension to brand name drugs under certain conditions. G. Prescription Drug Marketing Act of 1987 (PDMA)
1. Requires state licensing of prescription drug wholesalers under federal guidelines. 2. Bans re-importation of prescription drugs produced in the US. 3. Bans sale trade or purchase of samples
4. Mandates storage, handling and recordkeeping requirements for drug samples. 5. Prohibits, with certain exceptions, the resale of prescription drugs purchased by hospitals or health care facilities. H. FDA Modernization Act of 1997 (FDAMA)
1. Made major changes to the Food, Drug and Cosmetic Act. 2. Replaced prescription legend “Caution: Federal law...