1.

What is meant by drug standards

-federally approved requirements/rules set to assure consumers that they get what they pay for
-law says: all preparations called by same drug name must be of uniform strength, quality, and
purity
-drug companies must not add other active ingredients or varying amounts of chemicals to
specific drug preparation
-illegal (illicit) drugs: danger to consumer due to lack of enforcement of drug standards (no
QC=deaths by OD)

2. Name the first drug law passed in the US for consumer safety and what year it was
passed
1906 Pure Food and Drug Act:
*all drugs marketed in the US: meet minimal standards of strength, purity, and quality
*drugs preparations w/ dangerous ingredients must have labeled container indicating ingredient
(originally 11 dangerous ingredients…such as morphine)
*established 2 references of officially approved drugs (before, no official written resources
existed): United States Pharmacopeia(USP) & National Formulary(NF)

3. Summarize the provisions of the Federal Food, Drug, and Cosmetic Act of 1938, and
identify the government agency that enforces the act
1938 Federal Food, Drug, and Cosmetic Act and Amendments
*came about because in 1937, sulfa preparation that was not adequately tested for safety was
responsible for 100 deaths
*established Food and Drug Administration(FDA) under Department of Health and Human
Services(DHHS) to enforce
provision of act/ensure
basic standards to be
followed
-established more specific
regulations to prevent
adulteration of (tampering
with) drugs, foods, and
cosmetics:
o labels must be accurate
+ include listing of all
active/inactive
ingredients
o new products must be
approved by FDA before
public release
o “Warning” labels must
be present on certain
preparations (e.g. “may cause drowsiness/nervousness/habit forming”)
 o certain drugs must be labeled with the legend/inscription (e.g. “Caution-federal law
prohibits dispensing without a prescription.”
o prescription/nonprescription drugs must be shown to be effective and safe

4. Interpret what is meant by USP/NF

-before 1906, drug info was handed down from generation to generation with no official written
resources in existence
-after 1906 Pure Food and Drug Act, USP and NF specified official US standards for making each
drug
-now it has been combined into one book: USP/NF

5. Summarize the provisions of the Controlled Substances Act of 1970

- urgent need for better control of addictive drugs established Drug Enforcement
Administration (DEA) as bureau of Department of Justice to enforce provisions of act/handle all
needs and safety controls for dangerous drugs
-set tight controls on drugs that were being abused by society (depressants, stimulants,
psychedelics, narcotics, anabolic steroids)
-isolated abused/addicting drugs into 5 lvls/schedules according to medical value, harmfulness,
potential for abuse or addiction
-demanded security + accountability of controlled substances
-anyone who dispenses, receives, sells, or destroys controlled substances must have
DEA forms indicating exact current inventory and keep 2yr inventory of controlled substance
transaction
-set limitations on use of prescriptions
-guidelines established for controlled substances, regulating # times drug may be
prescribed in a six-month period as well as for which schedules prescriptions may be phoned in
to the pharmacy, etc
-demanded prescriber register with DEA and obtain DEA registration number, to be present on
prescriptions of controlled substances; drug manufacturers must be registered and ID with own
DEA numbers, as must pharmacists, physicians veterinarians, etc

6. Explain what is meant by a DEA number and the NDC Directory

DEA registration #: prescriber/manufacturer has to register with DEA for DEA reg # that has to
be present on prescription of controlled substances
National drug Code (NDC) Directory established in 1972 to provide FDA with list of all drugs
manufactured for commercial distribution
-each drug identified by NDC number made of 3 parts:
1)5 numbers and IDs the manufacturer
2)4 numbers and IDs the drug
3)2 digits and IDs the package size
**example: 00406-0123-01 ; common practice to omit leading 0 in first or second part of NDC #

7. Define schedules of controlled substances and differentiate between C-I through C-V
schedules
 -5 schedules of controlled substances arranged from I-V and I is highest potential for abuse
-even drugs in class lvl V have more potential for abuse than most drugs
-lower the number, stricter the restrictions for control by the DEA thus schedule I drugs are
illegal and not approved for medicinal purposes in the US
-drugs are frequency added, deleted, or moved from one schedule to another up to DEA
determination
-labels on controlled substances designated with C and Roman numeral to indicate lvl of control
-drug inserts (info leaflets accompanying drugs) are also marked with C and appropriate
schedule number

8. State several responsibilities you have in administering medications as a direct result of

the three major drug laws described in this chapter
***3 major acts1906 Pure Food and Drug Act
1938 Federal Food, Drug, and Cosmetic Act and Amendments of 1951 and 1962
1970 Controlled Substances Act
*GUIDELINES FOR DISPENSING:
1)have available current drug reference source/ readily able to ID controlled substances
2)lock up controlled substances (double-locking ie locked safety box in locked cupboard)
3)conceal/secure prescription pads/ do not leave pads out in the open
4)accurate records of controlled substances administered/received/destroyed for during
past 2 yrs; also properly destroy expired drugs/old records
5)be up to date with FDA/DEA + informed with changes of sched of controlled drugs;
registration renewals
6)establish working rapport with pharmacist
7)establish professional rapport with pharm repsAffordable Care Act/Sunshine Act
requires reporting of compensation/gifts paid to phys by pharm reps…so be aware of ethical
dilemma

9. Define Key Terms and Concepts:

a. Controlled substances

b. Drug Enforcement Administration

-concerned only with controlled substances
-enforces laws against drug activities (illegal drug use, dealing, manufacturing)
-monitors need for changed sched of abused drugs
-created as need for better control of addictive drugs became urgent
-handles all needs/safety controls for more dangerous drugs

c. Drug standards
-assure consumers that they are getting what they pay for
-all preparation under same drug name uniform: strength quality, purity

d. Food and Drug Administration (FDA)

-federal FDA established to ensure basic general safety standards be followed due to
increased dangers from increased # drugs in market
-oversee testing of proposed new drugs before market release
-inspect plants where foods/drugs/med devices/cosmetics are made
-review new drug applications and petitions for food additives
-investigating/removing unsafe drugs from market
 -ensure proper labeling of foods/cosmetics/drugs
-approval/removal of products on market
*conclusion that drug should be removed from market based on nature and
freq of adverse events as well as drug’s benefit and risk balance compares with alt
treatment

e. National Drug Code (NDC) Directory

1972 National Drug Code Directory: provided FDA with list of all drugs for commercial
distribution

1) 5 numbers: manufacturer ID
2) 4 numbers: drug ID
3) 2 digits: IDs the package size

*2 significant pieces of drug legislation: 1983 Orphan Drug Act and Omnibus Budget
Reconciliation Act(OBRA) of 1990
f. Orphan Drugs
-1983 Orphan Drug Act: gives pharm companies financial incentives to develop
medications for diseases that affect only small # ppl
-encourages companies to develop orphan drugs that would otherwise be of
low profitability
g. Over-the-counter (OTC) medication
-OBRA of 1990: mandates OTC drugs be documented as part of Medical Record and
pharmacists must provide drug use review/pt counseling before dispensing
prescriptions to pt
-have serious, responsible attitude about all aspects of drug therapy
-be aware of legalities of dispensing meds and consider misconceptions + facts