By William Feinberg
A concise, two-in-one overview of pharmacy law-ideal for coursework and MPJER examination prep!This available, real-world consultant will get you prepared for the perform of pharmacy, whereas supplying you with the correct education to be compliant with the legislations. as a consequence, the publication expertly covers appropriate legislation, principles, and laws, and it highlights the differences among nation and federal legislations the place acceptable. In no different reference are you able to locate the sort of succinct, but thorough assessment of the whole variety of federal pharmacy legislation, together with the managed elements Act, the nutrition, Drug, and Cosmetics Act, the recent nutritional complement future health schooling Act, the FDA Modernization Act, and the Medicare Modernization Act.Features: * an exceptional primer for coursework and unbeatable guidance for licensure and the MPJER * beginning bankruptcy on drug rules and criteria offers you a realistic felony framework for next bankruptcy fabric * assessment of the drug approval procedure and federal reporting courses * bankruptcy on web revenues and FDA authority to behave * insurance of opioid habit therapy and narcotic remedy courses, providing you with a special close-up of the most recent legislation and regulations * entire set of 450 multiple-choice questions and solutions * bankruptcy of MPJER-format perform questions
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Additional info for Pharmacy Law: Textbook & Review
5 Prescription to Over-the-Counter Switch Over-the-Counter Review The over-the-counter (OTC) review process was initiated in 1972. The Food and Drug Administration (FDA) appointed qualified experts to advisory review panels. These experts reviewed drug products based on their product therapeutic classification, that is, laxative, emetic, analgesics, to determine if they are safe and effective for OTC administration. It took over 10 years to review over 700 ingredients and over 400,000 products.
Subscribers have the ability to share data amongst hospitals and health systems. com>>, is a computer-based risk management program to control the distribution and use of isotretinoin. Isotretinoin is used to treat severe recalcitrant nodular acne. It has a high risk of birth defects when used in pregnant women. Because of the risk, use of isotretinoin in women is very restrictive. The previous SMART program was not as effective as the FDA wanted. This new program requires registration of all wholesalers distributing isotretinoin, all prescribers prescribing isotretinoin, all pharmacies dispensing isotretinoin, and all male and female patients prescribed isotretinoin.
Multisource drug products are drug products that are manufactured by several manufacturers. Pharmaceutical equivalence refers to drug products with the same active ingredients, same dosage form, same route of administration, and identical in strength or concentration. These products must meet the same compendial standards for purity, quality, strength, and labeling. Therapeutic equivalents are those products that are pharmaceutical equivalents and bioequivalent. The FDA utilizes the following criteria to determine if a drug product is a therapeutic equivalent: 1.