Pharmaceutical Regulations: Durham-Humphrey Amendment

It was established to address the issue of drug manufacturers labeling products as either OTC or prescription.

Prescription drugs are categorized based on safety, method of use, and compliance with the new drug application indicating it is prescription only.

<ol> <li>Toxicity, 2) Prove harm from unsupervised use, 3) Drug requires collateral measures.</li> </ol> Signup and view all the answers

<p>It means that if a drug cannot cure the patient, the delay in doctor visit required for its use is harmful.</p> Signup and view all the answers

<p>Oral prescription</p> Signup and view all the answers

<p>In the original prescription.</p> Signup and view all the answers

<p>They would have to follow the same labeling requirements as drug manufacturers.</p> Signup and view all the answers

<ol> <li>Name and address of the dispenser, 2) Serial number and date of prescription, 3) Name of the prescriber and patient, 4) Directions for use and cautionary statements.</li> </ol> Signup and view all the answers

<p>It shall not be later than the expiration date on the manufacturer's container, or one year from the date when the drug is dispensed, whichever is earlier.</p> Signup and view all the answers

<p>24 months from their date of manufacture.</p> Signup and view all the answers

<p>They must be stable for at least 3 years, have no dosing limitations, and be safe and suitable for frequent and prolonged use.</p> Signup and view all the answers

<p>An amendment requiring an evaluation of all marketed drugs, both OTC and prescription, for efficacy.</p> Signup and view all the answers

<p>They evaluated OTC products based on therapeutic categories rather than individually.</p> Signup and view all the answers

<p>Manufacturers must remove, reformulate, and relabel or withdraw the product and follow NDA procedures.</p> Signup and view all the answers

<p>Category I = Ingredients generally recognized as safe and effective and not misbranding. Category II = Ingredients that are not generally recognized as safe and effective or that are misbranded. Category III = Ingredients for which data available are insufficient to permit classification.</p> Signup and view all the answers

<ol> <li>Manufacturer may request switch by a supplemental application to its approved NDA, 2) Manufacturer may petition the FDA, 3) Drug may switch during the OTC review process.</li> </ol> Signup and view all the answers

<p>Because some manufacturers changed to OTC status by submitting a supplemental application while others did not; pharmacists should follow the label.</p> Signup and view all the answers

<p>Third class drugs (behind-the-counter) include insulin, syringes, pseudoephedrine, plan B.</p> Signup and view all the answers

<p>Only the physician.</p> Signup and view all the answers

<p>State law.</p> Signup and view all the answers

<p>Legislation allowing pharmacists to initiate or adjust drug therapies in collaboration with a physician.</p> Signup and view all the answers

<p>Yes, by the same standard (DHA) as pharmacists.</p> Signup and view all the answers

<p>Oral contraceptive drugs, estrogen containing drugs, diethylstilbestrol (DES), IUD contraceptive device.</p> Signup and view all the answers

<p>Before the first dose and 30 days thereafter.</p> Signup and view all the answers

<p>Patient labeling for products posing serious concerns which help prevent adverse effects and ensure adherence.</p> Signup and view all the answers

<p>Motrin, Abilify, SSRIs (Prozac), Ambien, Accutane, Lotronex, Lariam, and Lindane.</p> Signup and view all the answers

<ol> <li>Practitioners find new uses for drugs faster than regulatory processes, 2) Manufacturers seek NDA approvals for a minimal number of indications to speed the process.</li> </ol> Signup and view all the answers

<p>If the risk is unreasonable, the pharmacist has a duty to call the prescriber and document the call.</p> Signup and view all the answers

<p>The prescriber.</p> Signup and view all the answers

<p>A term defined as the products display comparable bioavailability under similar conditions.</p> Signup and view all the answers

<p>Products that contain the same active ingredients, are identical in strength, and are in the same dosage form.</p> Signup and view all the answers

<p>Pharmaceutical equivalents that are expected to have the same clinical effect and safety.</p> Signup and view all the answers

<ol> <li>Drugs marketed before 1938, 2) Certain generics that demonstrate bioavailability but not bioequivalence.</li> </ol> Signup and view all the answers

<p>Carbamazepine, Clonidine, Levothyroxine, Lithium, Phenytoin, Warfarin, Theophylline.</p> Signup and view all the answers

<p>80-125%.</p> Signup and view all the answers

<ol> <li>Look up the drug product. 2) Find the same dosage form and strength in the Orange Book. 3) Check if it's classified as 'A' and not on the Exception List. 4) If it's 'B', refer to additional lists. 5) If listed in additional lists, it is interchangeable.</li> </ol> Signup and view all the answers

<p>For medicinal and research purposes.</p> Signup and view all the answers

<p>Tax-paid ethyl alcohol, usually 190 proof grain alcohol purchased from authorized outlets.</p> Signup and view all the answers

<p>Must be stored in a securely locked storeroom with intact labels; labels must be obliterated before discarding empty containers.</p> Signup and view all the answers

<ol> <li>Hazardous substances under the federal Hazardous Substance Act, 2) Economic poisons under the federal Insecticide Act, 3) Foods, drugs, or cosmetics under the FDA, 4) Household fuels stored in portable containers.</li> </ol> Signup and view all the answers

<p>80%, and 90% of adults must be able to open them.</p> Signup and view all the answers

<p>Plastic bottles cannot be reused; glass bottles can, but the plastic cap needs to be replaced.</p> Signup and view all the answers

<ol> <li>Non-compliant container requested by physician or patient, 2) OTC products with labels stating no child-resistant packaging, 3) Dispensed to institutionalized patients, 4) Certain prescription drugs requiring immediate use.</li> </ol> Signup and view all the answers

<ol> <li>SL nitroglycerin, 2) SL and chewable forms of isosorbide dinitrate, 3) Sodium fluoride, 4) Anhydrous cholestyramine, 5) Methylprednisolone, 6) Erythromycin ethylsuccinate granules.</li> </ol> Signup and view all the answers