Pharmacy Tech laws and drug schedules

1906- Federal Food and Drug Act

this act prohibits he sale of adulterated or mislabeled food, drinks, and drugs

1914- Harrison Narcotic Act

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

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 prescription", requires physician supervision for the purchase of legend drugs.

1938- Food Drug Cosmetic Act

This act made e food and drug act more comprehensive to include cosmetics, also defines misbranding or adulteration of drugs to be illegal. This act requires drug companies to provide packet insert, 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.

1962- Kefauver-Harris Amendment

Required proof of EFFECTIVENESS for Rx and OTC drugs marketed after 1938.

1970-Comprehensive Drug Abuse Prevention and Control Act

Controlled substance act;Classified drugs into 5 catagories based on abuse schedules I-V. DEA was formed.

1970-Poison Prevention Act

requires child-proof packaging on all controlled and most prescription drugs;can sign waiver for non-child proof

1983- Orphan Drug Act

Gives economic incentives to manufacturers to produce drugs which only a few people may need( rare diseases)

1984- Hatch-Waxman Amendment

this act streamlines the process for granting approval of generic drugs. it may also give manufacturers incentives to develop new drugsby giving patent extensions. Allows generic drug companies the ability to rely on the safety and efficacy findings of an innovators 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 Marketing 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.

1996- Health Insurance Portability and Accountability Act (HIPAA)

rules regarding the privacy/security of patient health information.

2006- Combat Methamphetamine Epidemic Act (CMEA)

this acts limits the purchase of pseudophedrine (pse) products to 3.6g of pse per day or 9g per 30 days.

alprazolam

XANAX Schedule IV

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.

Amphetamines

Schedule II Adderal

Anabolic Steroids

Schedule III

Antidiarrheals w/ opiod

Schedule V Lomotil

Antitisussives w/ codeine

Schedule V Robitussin AC

APAP + ocycodone

Schedule II Percocet

ASA + codeine

Schedule III Empirin # 3

ASA + oxycodone

Schedule II Percodan

Benzodiazepines

diazepam, alprazolam, lorazepam Schedule IV

clorazepate

schedule IV Tranxene

clonazepam

KLONOPIN Schedue IV

cocaine

Schedule II

Codeine

Schedule II Codeine

Codeine w/ acetaminophen

Schedule III Tylenol no. 3

DEA 41

Used to document the destruction of controlled substances

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 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 224

needed for a pharmacy to dispense controlled substances

DEA 225

needed to manufacture or distribute controlled substances

DEA 363

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

dextroamphetmine

Schedule II Dexedrine

diazepam

VALIUM Schedule IV

diethylpropion

Schedule IV Durad, Tepanil, Tenuate

DEA Number

a registration number assigned to physicians by the drug enforcement administration for prescribing or dispensing controlled drugs

Drobabinol

Schedule III Marinol

drug facts and comparisons

is a comprehensive medication information reference that is organized by therapeutic medication class. general information with alist of monographs

Drug Topics Red Book

Gives a listing of drugs by pricing, strengths, sizes, manufacturers, brands, and generics

Fentanyl

DURAGESIC Schedule II

flurazepam

Dalmane Schedule IV

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

Heroin

Schedule I

hydrocodone + guaifensin

Schedule III Hycotuss

hydrocodone + acetaminophen

Lortab, Vicodin, Lorcet, norco, Schedule III

Hydromorphone

DILAUDID, Schedule II

hydrocodone

Hycodan, Schedule III

ibuprofen + hydrocodone

Vicoprofen (CIII)

physicians desk referece

Compilation of product inserts from the pharmaceutical manufacturers. Contains indexes of manufacturers and product category; generic and trade names; product identification guide, product information; diagnostic product information; and miscellaneous information.

lorazepam

ATIVAN, Schedule IV

LSD

Schedule I

Marijuana

Schedule I

Material Safety Data Sheets

Abbreviated MSDS; information compiled by the manufacturer about product safety, including the names of hazardous ingredients, safe handling and use procedures, precautions to reduce the risk of accidental harm or overexposure, and flammability warnings.

Meperidine

DEMEROL, Schedule II

Mescaline

Schedule I

Methadone

Schedule II Dolphine

Methylphenidate

Schedule II ritalin

Morphine

Schedule II MS Contin

Mosby's Complete Drug Reference

Lists generic drugs in alphabetical order. Also contains additional drug information

National Drug Code

Unique number assigned to a brand name, generic, or OTC product to identify manuf., drug, & pkg size.

opium

Schedule II

Orange Book

FDA-published listing of Approved Drug Products with Therapeutic Equivalence Evaluations generally known as generics

OTC Labeling

the name of the product address of the manufacturer, packer or distributor. The net contents of the package. the established name of all active ingredients and quantity of, the name of any habit forming drugs contained in the product, and any caution labels and warnings needed to protect the customer

Oxycodone

Schedule II oxycontin

Pentazocine

Talwin Schedule IV

Pentazocine + Naloxone

Talwin Nx (CIV)

peyote

Schedule I

phenobarbitol

Schedule IV Solfoton

aplrazolam prescription

can be refilled five times

proxyphene + APAP

Darvocet N Schedule IV

Secobarbital

Schedule II Seconal

Temazepam

Schedule IV Restoril

Triazolam

Schedule IV Halcion

US Pharmacopoeia general chapter 797

States the procedures and requirements for pharmaceutical compounding of sterile preparations

US Pharmacopoeia/national formulary

contains monographs and chemical characteristics of drugs

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

Commercial Invoice

When ordering a CIII medication what document is required for proof of receipt?