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Federal Pharmacy Law Review









1906 – Federal Food and Drug Act
This act prohibits the sale of adulterated or mislabeled food, drinksand drugs
1914 – Harrison Narcotic Act
This act limits the transport of opium. In order to purchase opium, a prescription is required.
1938 – Food Drug and Cosmetic Act
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
1951 – Durham Humphrey Amendment
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
1962 – Kefauver-Harris Amendment
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.
1970 – Comprehensive Drug Abuse Prevention and Control Act (Controlled substance Act – CSA)
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.
1970 – Poison Prevention packaging act
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.
1983 – Orphan Drug Act
This act enables the FDA to promote the research and marketing of drugs needed for the treatment of rare diseases.
1984 – Drug price Competition and Patent-term restoration Act( Hatch-Waxman Amendment)
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.
1988 – Food and Drug Administration Act
This act established the FDA as an agency of the Department of Health and Human Services. Any adverse drug reactions and outcomes should be reported to the FDA
1988 – Prescription Drug Marketing Act
This act banned the sale, trade, or purchase of drug samples
1990 – Omnibus Budget Reconciliation Act (OBRA)
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.
1996 – Health Insurance Portability and Accountability Act (HIPAA)
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.
2006 – Combat Methamphetamine Epidemic Act (CMEA)
This act limits the purchase of pseudophedrine(pse) products to 3.6g of pse per dat or 9g per 30 days
Class I Recall
An attempt must be made to notify the patient that the drug he/she may be taking could cause serious harm or death
Class II recall
The probability of serious harm is not likely and the effects may be temporary or reversable. This recall does not go to the customer level and is usually due to problems with consistency of potency
Class III recall
Not likely to cause any serious adverse effects and does not go to the customer level
OTC labeling must contain:
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)
Food, Drug, and cosmetic act requires precription drugs to contain:
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 without a prescription”, package insert on selected drugs.
Package inserts must contain:
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
Package inserts must be distributed with the following drug classes:
Oral contraceptives, estrogen-containing and progestational drugs, intrauterine contraceptive devices, diethylstilbestrol products, accutane, metered-dose inhalers
National Drug Code (NDC)
Each drug produced by a manufacturer is identified with a specific NDC number. THe NDC number is composed of three sets of numbers, which identifies the manufacturer, drug, and pack size.
NDC first set (five numbers) indicate what?
Manufacturer
NDC second set/middle set (four numbers) indicates what?
Specific drug – each drug has its own number
NDC last two numbers indicate what?
Package size – (100 tablets may be 01, 500 tablets may be 05)
Schedule I drugs
These drugs have NO accepted medical use in the united states. These drugs have the highest abuse potential
Schedule II drugs
These drugs may NOT be refilled. The ordering of these drugs requires a DEA 222 form. The returning of out-of-date schedule II drugs requires a DEA 222 form. These drugs have a high abuse potential that may lead to sever physical or psychological dependence
Schedule III drugs
These drugs may be refilled 5 times in a six month period. These drugs have less potential for abuse/dependence than schedule I or schedule II drugs
Schedule IV drugs
These drugs may be refilled 5 times in a 6 month period. These drugs have less potential for abuse/dependence than schedule II/III drugs.
Schedule V drugs
These drugs have less potential for abuse than schedule II, III, and IV drugs.
Heroin
Schedule I
Peyote
Schedule I
LSD
Schedule I
Marijuana
Schedule I
Mescaline
Schedule I
Cocaine
Schedule II
Morphine
Schedule II MS Contin
Amphetamines
Schedule II Adderal
Codeine
Schedule II Codeine
Opium
Schedule II
Methadone
Schedule II Dolophine
Oxycodone
Schedule II Oxycontin
Hydromorphone
Schedule II Dilaudid
Fentanyl
Schedule II Duragesic
Meperidine
Schedule II Demerol
Methylphenidate
Schedule II Ritalin
Secobarbital
Schedule II Seconal
Codeine w/ acetaminophen (tylenol No. 3)
Schedule III
Hydrocodone w/ acetaminophen (vicodin, lorcet, lortab, norco)
Schedule III
Drobabinol (Marinol)
Schedule III
Anabolic steroids(testosterone)
Schedule III
Cough syrups containing hydrocodone
Schedule III Tussionex
Benzodiazepines(diazepam, alprazolam, lorazepam)
Schedule IV
Phentermine
Schedule IV Fastin
Pentazocine
Schedule IV Talwin
Phenobarbitol
Schedule IV Solfoton
Diethylpropion
Schedule IV Durad, Tepanil, Tenuate
Antitussives w/codeine
Schedule V Robitussin AC
Antidiarrhealsw/opioid
Schedule V Lomotil
Controlled substance inventory must be done how often?
Every two years
Two file Prescription filing system #1:
One file for CDS-CII and CDS-CIII-CV(marked with a red “C” one inch high at thebottome right corner) and another file for all other prescriptions
Two file prescription filing system #2:
One file for CDS-CII only. Another file for CDS CIII-CV and all other drugs (CDS-CIII must be marked with a one inch high red “C” on the bottom right corner)
Three file prescription filing system:
One file for CDS-CII, one file for CDS- CIII-CV and one file for all other prescriptions
DEA 222
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)
DEA 106
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)
DEA 41
Used to document the destruction of controlled substances
DEA 224
needed for a pharmacy to dispense controlled substances
DEA 363
needed to operate a controlled substance treatment program or compound controlled substances
DEA 225
needed to manufacture or distribute controlled substances
A doctor that precribes medications must have this?
DEA Number
Valid DEA Number
2 letters followed by 7 numbers. First letter is an A or B. Second letter is first letter of last name. The last number of the sum of odd numbers + (sum of even number) * 2 should equal the last number
Orange Book(approved drug products w/therapeutic equivalence evaluations)
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.
USP/NF US pharmacopoeia/National Formulary
Contains monographs and chemical characteristics of drugs
USPDI US pharmacopoeia dispensing information
Volume I:Drug info for healthcare providerVolume II: Drug info for patientsVolume III: Therapeutic equivalency information and pharmacy law
US Pharmacopoeia general chapter 797:
States the procedures and requirements for pharmaceutical compounding of sterile preparations
Drug facts and comparisons
Contains a comprehensive listing of drugs and comparative drugs. These drugs are organized by therapeutic class and provide general information with a list of monographs. Also contains listing of drug manufacturers, addresses and phone numbers. Updated monthly
Drug Topics Red Book
Gives a listing of drugs by pricing, strengths, sizes, manufacturers, brands, and generics
Handbook on injectable drugs
Lists injectable drug information such as compatability, storage and dosages
Physician’s Desk Reference(PDR)
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
Mosby’s Complete Drug Reference
Lists generic drugs in alphabetical order. Contains additional drug information
American Drug Index
Drugs 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.
Handbook of injectable drugs
Used to determine the compatibility of medications that will be used in an IV bag. Shows the compatability, solubility, and stability of medications
Material Safety Data Sheets
MSDS provides information on hazardous materials that may be in the pharmacy and also provides information on disposal, storage, safe use and clean up of these medications
When ordering a CIII medication what document is required for proof of receipt?
Commercial invoice
Because federal and state record keeping requirements can vary in each state, which law should be followed?
The most stringent law
For general laws concerning pharmacy rules and regulations, which law should be followed?
The most stringent law
To whom are drug recalls, drug reactions, and outcomes reported?
FDA
When drug manufacturers notify a pharmacy of a drug recall , how are the affected drugs identified?
Lot number and expiration date
What do the first five, middle four, and last two digits of an NDC number represent?
Manufacturer, drug, package size
A list of drug package inserts could be located in which book?
Physicians desk reference
What is the maximum amount of refills for CIII-CV prescriptions in a six-,month period?
5 refills
Who may initiate the ordering of an investigational drug?
Physician
Who may order controlled substance schedule CI drugs?
No one
The expiration date on a bottle of Naproxen is 8/08. When will this drug expire?
The last day of august
Which drug recall must go to the customer level?
Class I
Which form is used to report lost or stolen drugs?
DEA 106
Which schedule has no medicinal use?
Schedule I
Which form is used when ordering CII drugs?
DEA 222
A prescription for alprazolam may be refilled how many times?
5 times
dextroamphetmine
Schedule II Dexedrine
APAP + ocycodone
Schedule II Percocet
fentanyl
Schedule II Duragesic
ASA + oxycodone
Schedule II Percodan
ASA + codeine
Schedule III Empirin # 3
hyrdocodone
Shceulde III Hycodan
ibuprofen + hyrocodone
Schedule III Vicoprofen
carisoprodol + codeine
Schedule III Soma with codeine
hydrocodone + guaifensin
Schedule III Hycotuss
lorazepam
Schedule IV Ativan
flurazepam
Schedule IV Dalmane
proxyphene +APAP
Schedule IV Darvocet N
alprazolam
Schedule IV Xanax
diazepam
Schedule IV Valium
clorazepate
Schedule IV Tranxene
pentazocine – naloxone
Schedule IV Talwin NX
pentazocine
Schedule IV Talwin
TEMAZEPAM
Schedule IV Restoril
clonazepam
Schedule IV Klonopin
triazolam
Schedule IV Halcion