Pharmacy Laws and Abbreviations

Pure Food and Drug Act of 1906

Prohibited food and drugs that were distributed through interstate commerce to be adulterated or misbranded.

Food, Drug and Cosmetic Act of 1938

Passed after diethylene glycol deaths. Required any new drug could not be marketed unless it had first been proven to be safe wen used according to the directions on the label. Required labels to include adequate directions for use and warning about habit-forming. Drug prior to 1938 were grandfathered.

Durham-Humphrey Amendment of 1951

Established two classes of drugs: prescription/legend and OTC.

Kefauver-Harris Amendment of 1962

Passed after concern with Thalidomide. Required all new drugs marketed after 1938 to not only be safe, but also effective. Placed authority for regulating prescription in the hands of FDA. Informed consent of research subjects, reporting of ADR, Good Manufacturing Practices.

Medical Device Amendment of 1976

Provides better classification of medical devices according to their specific function, establishment of performance standards, pre-marketing approval requirements, conformance with GMP standards, adherence to record and reporting requirements.

Orphan Drug Act of 1983

provided various tax and licensing incentives to manufacturers to make development of orphan drugs more appealing.

Drug Price Competition and Patent-Term Restoration Act

AKA Hatch-Waxman amendment. Required submission of only ANDA for generic drugs, which only requires proof of bioequivalence with its brand name counterpart. Brand name drugs manufacturers were given 5 additional year of patent.

Prescription Drug Marketing Act of 1987

Requiring that prescription drug wholesalers be licensed, banned re-importation of prescription drugs produced in U.S., banned the sale, trade or purchase of drug samples, specified storage, handling, record keeping requirements, prohibit the resale of prescription drugs purchased by hospitals.

FDA Modernization Act of 1997

Provided fast-track review of New Drug Applications, clarified conditions for extemporaneous compound in pharmacies, "Caution: Federal law prohibits dispensing without a prescription" is replaced by "Rx only". "Warning-May be habit forming" eliminated for some, encourage research for new uses of drugs and to submit supplemental NDAs, encourage pediatric studies of drugs by providing them with an additional 6 months of marketing exclusivity.

Patient Protection and Affordable Care Act (Health Care Reform Act) of 2010

1. Required all individuals to have health insurance. A Health Insurance Exchange created to allow purchase of coverage based on Federal Poverty Level. 2. Require standards for financial and administrative transactions including timely and transparent claims using standard electronic transactions. 3. Stop agreements between brand name and generic drug manufacturers that limit or delay competition from generic drug. 4. Require elimination of donut hole or coverage gap.

US Pharmacopoeia/National Formulary

published by U.S. Pharmacopoeia Convention.

Homeopathic Pharmacopoeia of the US

published by private organization that updates info about homeopathic products.

AAC

Actual Acquisition Cost-the actual price a pharmacist pays when purchasing units of a drug product. Usually a discounted price from the Average wholesale price.

AARP

American Association of Retired Persons

ADE or ADR

Adverse Drug Experience or Reaction

AMP

Average Manufacturer Price-average price paid by wholesalers to a manufacturer for drugs that are to be sold at retail.

ANDA

Abbreviated New Drug Application

ATF

Alcohol, Tobacco, and Firearms agency

AWP

Average Wholesale Price-a published wholesale price for a drug product that can be used as the basis for pricing prescription drugs. Usually pharmacies are able to purchase the drug at lower prices from the AWP.

CAM

Complementary and Alternative Medicine

CDC

Centers for Disease Control

CDER

Center for Drug Evaluation and Research

CFR

Code for Federal Regulations-a compilation of final regulations and notices promulgated by the federal government; published annually by the U.S. Government printing office, the above regulations and notices are first published in the federal Register, a daily publication.

CMS

Centers for Medicare and Medicaid Services-responsible for administering Medicare and overseeing state's administration of Medicaid; formerly known as the Health Care Financing Administration.

CPSC

Consumer Product Safety Commission

DEA

Drug Enforcement Administration-responsible for the federal controlled Substance Act (CSA). It is part of the U.S. department of justice.

DHHS

Department of Health and Human Services-department which includes the Food and Drug Administration

DI

Dietary Ingredient-may be a vitamin, mineral, herb or other botanical, an amino acid, or another dietary substance that supplements the diet.

DME

Durable Medical Equipment-equipment that meets three standards: can stand repeated use, primary for medical purpose, appropriate for use in the home.

DRG's

Diagnosis Related Groups-a classification system for hospital inpatients based on the principal diagnosis; reimbursement is usually based on days of stay.

DS

Dietary Supplement-an over the counter product, containing one or more dietary ingredients, that is taken to improve upon a health condition, or simply enhance health.

DSHEA

Dietary Supplement Health Education Act

DUR

Drug Utilization Review- a review of prescription drug use, prescribing patterns or drug utilization by patients. Its purpose is to determine if appropriate drugs are being prescribed and if those drugs are being used appropriately.

EAC

Estimated Acquisition Cost- an estimated cost of an drug to a pharmacy based upon information collected by the DHHS. Such costs are often based upon the quantity purchased.

EOB

Electronic Orange Book

FDA

Food and Drug Administration

FDCA

Food, Drug and Cosmetic Act

FTC

Federal Trade Commission-responsible for investigating unfair business practices including misleading advertising, etc.

GMP

Good Manufacturing Practice

GRAS

Generally Recognized as Safe-refers to a large number of a relatively inert ingredients that are permitted to be used in pharmaceutical and food products as excipients because of their relatively high degree of safety.

HCFA

Health Care Financing Administration-formerly responsible for policies relating to Medicare and Medicaid. Now referred to as Centers for Medicare and Medicaid Services.

HHA

Home Health Agency-an organization licensed or certified by the government to provide home health care services

HIPAA

Health Insurance Portability and Accountability Act

HMO

Health Maintenance Organization

HP/HPUS

Homeopathic Pharmacopoeia of the United States

HSD

Home-use Sterile Drug products

IND

investigational New Drug

JCAHO

Joint Commission on Accreditation of Health Care Organizations

LVP

Large Volume Parenteral

MAC

Maximum Allowable Cost-the highest price allowed under a specific plan for a specific drug

NABP

National Association of Boards of Pharmacy

NDA

New Drug Application

NDC

National Drug Code-a classification system for identifying a specific drug product; used nationally for reimbursement and for identification of drug products

NIH

National Institutes of Health

NDI

New Dietary Ingredient. Any substance that was not marketed as a dietary supplement ingredient in the U.S. prior to October 15, 1994.

Non-DI

An excipient or other substance used in the manufacture of a dietary supplement DS.

NPI

National Provider Identifier

OBRA

Omnibus Budget Reconciliation Act- act passed each year by Congress to fund many activities; each OBRA is known by the year it was enacted.

OSHA

Occupational Safety and Health Administration-responsible for monitoring the work environment to assure worker safety.

OTC

over the counter- refers to drugs and drug products, which are available without a prescription; also referred to as "non-prescription."

PBM

Pharmacy Benefits Management- organization that manages pharmaceutical benefits for managed care organizations or employers.

PFFS

Private fee-for-service plans that allow you to go to any doctor or hospital that accepts their terms.

PHS

Public Health Service

PI

Package Insert

PPI

Patient Package Insert

PPO

Preferred Provider Organization-a group of health professionals who are contractually favored to provide health services to individuals under a specific insurance plan

PPPA

Poison Prevention Packaging Act

SDA

Specifically Denatured Alcohol

SNDA

Supplemental New Drug Application

SNF

Skilled Nursing Facility- a site that treats patients especially in need of rehabilitation or a lower level of medical care than is needed in a hospital

SNP

Special Needs Plan- a category of Medicare Advantage plan designed for people living in long-term care facilities and receiving both Medicare and Medicaid or who have certain disabling chronic illnesses.

SP

Sterile product or supervising pharmacist

TCAM

Traditional, complementary, and alternative medicine

TRP

Tamper resistant Packaging

USAN

United States Adopted Names

USP DI

United States Pharmacopoeia Dispensing Information- a set of three volumes containing a variety of information, including Volume I Drug Info for Health Care Professionals, Volume II Advice for Patients, Volume III Approved Drug Products with Therapeutic Equivalence Evaluations.

Cosmetics

Article intended to be rubbed, poured, sprinkled, sprayed on, introduced into or otherwise applied to the human body for the purpose of cleansing, beautifying, promoting attractiveness.

Device

Any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or related article which is recognized in the USP/NF or HPUS or any supplement, intended for use in diagnosis and treatment, intended to affect the structure or any function of body.

Drug

Drugs may be any article recognized in USP/NF, HPUS, article intended for use in diagnosis and treatment, article intended to effect structure or function of body.

Drug sample

a unit of drug product not intended to be sold.

Food

an article used for food or drink in humans.

Generic Name

a name that is assigned to a specific drug structure. It is a simplified name as compared to the chemical name. Drugs may be marketed under their generic name or a brand name.

Hospice

a facility or program that provides palliative and supportive care for terminally ill patients.