Pharmacy Technician Certification (PTCB) Review - Federal Pharmacy Law

This act prohibits the sale of adulterated or mislabeled food, drinksand drugs

This act limits the transport of opium. In order to purchase opium, a prescription is required.

This act made the food and Drug Act more comprehensive to include cosmetics. The act also defines misbranding or adulteration of drugs to be illegal, This act requires drug companies to provide package inserts,requires that habit-forming drugs be labeled "may be habit forming" , requires that a new drug has to be proven safe under FDA guidelines before marketing

This act distinguishes legend drugs(prescription) from the over the counter drugs (OTC). This act requires companies to label legend drugs "Caution:Federal law prohibits dispensing without a prescrition", requires physician supervision for the purchase of legend drugs. Also, over the counter drugs without medical supervision are required to have on the label: Product Name, Name and Address of manufacturer, Active ingredients, quantities of all other ingredients whether active or not

All drugs made from 1938 forward must be proven save and effective. Also the FTC now handles drug advertisement. Stricter requirements for drug approval. Manufacturersmust now register annually, be inspected ever 2 years, and report adverse effects of drugs.

Drug enforcement agency (DEA) was formed.  Also controlled substanced were placed in schedules I-V based on abuse potential.Schedule I drugs have the highest abuse potential and schedule V drugs have the lowest abuse potential.

This act required childproof packaging on most drugs dispensed in a pharmacy. Drugs that are exempt from this act are drugs used in emergency situations, such as dispensing nitroglycerin, or if a drug is packaged in such a small quantity it would not hard a child under 5 years old.

This act enables the FDA to promote the research and marketing of drugs needed for the treatment of rare diseases.

This act streamlines the process for granting approval of generic drugs. It also give manufacturers incentives to develop new drugs by giving patent extensions. This act allows  generic drug companies the ability to rely on safety and efficacy  findings of an innovator's drug after the expiration of the patent.

This act requires a pharmacist to attempt or offer counsel to patients on all new prescriptions. Pharmacist must provide anem and description of drug, how much should be taken, side effects, contraindications, interactions, adverse effects, storage, refill information, and what to do if a dose is missed.

This act created rules regarding the privacy/security of patient health information. This act provides limitations on who can access, distribute, and receive patient information. This act also makes health insurance portable for people switching jobs. This act also includes provisions that make health care information processing more cost effective by requiring standardized electronic submissions of claim information.

This act limits the purchase of pseudophedrine(pse) products to 3.6g of pse per dat or 9g per 30 days

Name/address/phone# of dispensing pharmacy, patient and doctor's name, prescription number and the date filled, drug name/strength/quantity/directions for use, name/initials of dispensing pharmacist or technician, patient address, expiration date, refill information, precautions, the statement "federal law prohibits dispensing with

Compares therapeutic equivalence using an alphabetic rating system. A rated products can be substituted and B rated products cannot because they are not bioequivalent. This is published yearly

States the procedures and requirements for pharmaceutical compounding of sterile preparations

Lists injectable drug information such as compatability, storage and dosages

Product Name, manufacturer address, net contents, all ingredients(active or inactive), habit-forming drugs contained within, caution/warning labels, directions for use(drug's purpose, dosage, frequency of administration in accordance to meals, symptoms, etc, route of administration)

Description of the drug, Clinical pharmacology, indications and usage, contraindications/precautions/warnings/adverse reactions, drug abuse/dependance/overdosage information, dosage/administration information, the date of the most recent label revision

Oral contraceptives, estrogen-containing and progestational drugs, intrauterine contraceptive devices, diethylstilbestrol products, accutane, metered-dose inhalers

needed to manufacture or distribute controlled substances

needed to operate a controlled substance treatment program or compound controlled substances

needed for a pharmacy to dispense controlled substances

Used to document the destruction of controlled substances

Used to report lost or stolen controlled substances. (required when 5% of yearly product sold is missing - ie 50 tablets from a 1000 yearly supply)

Used for purchsing and returning of outdated CII drugs (blue copy:purchaser keeps for 2 years, green copy:seller sends to local DEA, brown copy:seller keeps on file)

Contains monographs and chemical characteristics of drugs

Volume I:Drug info for healthcare provider Volume II: Drug info for patients Volume III: Therapeutic equivalency information and pharmacy law

Contains packet insert drug information intended for physicians and is published annually. Contains color pictures with a list of drug manufacturers including addresses and phone numbers

Lists generic drugs in alphabetical order. Contains additional drug information

rugs are listed alphabetically and provide brand,generic and the chemical names of the drugs. Gives alist of manufacturers, strengths and dosage forms of the drugs listed.

Commercial invoice

FDA

Physicians desk reference

Center for Drug evaluation and Research