Section 3: Federal Pharmacy Law

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it prohibits the distribution or sale of adulterated or misbranded foods and drugs.

When was it enacted?

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Food, Drug, and Cosmetic Act(FDCA) - 1906

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This legislation oversees the marketing of all new drugs.

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Food, Drug, and Cosmetic Act(FDCA) - 1906

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the presence of any decomposed substance, packaging under unsanitary conditions, or if the product's strength, quality, or purity is different from what is indicated on the label.

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Adulteration

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false or misleading labeling or when proper warnings and directions are absent.

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Misbranding

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Must be filed to prove effcacy and safety before any drug is available commercially.

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New Drug Application (NDA)

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An amendment to the Food, Drug, and Cosmetic Act(FDCA) separating drugs into 2 categories:
Legend & Non-legend drugs

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Durham-Humphrey Amendment (1951)

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The following info must appear on the label of a drug approved for OTC distribution

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DIM CHoWN

D - directions for use
I - Ingredients (active & nonactive)
M - Manufacturer name & address

C - net contents
H - habit forming drugs in product
o - omit
W - warnings & cautions
N - name of product

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amendment to FDCA that standardized labeling requirements for the manufacturer and dispenser to the patients.

In what year was in established?

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Kefauver-Harris Amendment (1962)

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regulates proper drug advertising and package inserts issued by the manufacturer.

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Kefauver-Harris Amendment (1962)

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Manufacturers must register annually, be inspected at least once every 2 yrs and must report any drug reactions to the agency.
Must also follow standard investigational procedures for drug testing.

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Kefauver-Harris Amendment (1962)

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GMP were established with this legislation

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Kefauver-Harris Amendment (1962)

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THIS FEDERAL LAW WAS ENACTED TO TRY AND REDUCE ACCIDENTAL POISONINGS IN CHILDREN by requiring all pharmacy dispensed meds in child resistant containers.

What year was it established?

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Poison Prevention Packaging Act (1970)

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Exceptions to the PPPA ( 1970)

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EARL

E - emergency medications (nitroglycerin)
A - arthritic patients
R - requests written from patient/prescriber
L - labeled as non-child proof on OTC products

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contains amendments to the Medicare/Medicaid programs funded by the fed govt.

What year?

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OBRA - Omnibus Budget Reconciliation Act (1990)

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This act requires that only drugs that are approved as safe and effective will be reimbursed

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OBRA (1990)

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This act requires that pharmacists must provide consulting services when dispensing medications.

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OBRA (1990)

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Federal lesiglation regulating the use and distribution of drugs and other substances of abuse.

Year enacted?

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CSA - Controlled Substance Act (1970)

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Agency of the US Dept. of Justice and is responsible w/ the FDA for administering the provisions of the CSA.

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DEA - Drug Enforcement Agency

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Following activities requires registration w/ the DEA

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CRIME-N

C - compounding CS's
R - research & activities w/ CS's
I - Importing CS's
M - manufacturing, distributing, & dispensing CS's
E - Exporting CS's
N - Narcotic treatment programs

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Congress established 5 schedules of CS's based on

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abuse potential (mental & phsyical)

accepted medical use

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Which schedule of drugs has high potential for abuse?

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Schedule I

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Which schedule of drugs have low potential for abuse?

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Schedule V

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To secure (purchase or transfer) a supply of schedule I or II substances, a registrant must complete

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DEA Form 222 triplicate order form

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Who is permitted to sign the order forms?

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Only the person who signed the app for registration w/ the DEA

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In 1990, anabolic steroids were added to which schedule?

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Schedule III

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any drug or hormonal substance, chemically and pharmacologically related to testosterone that promotes muscle growth.

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anabolic steroids

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Why do some states sell controlled substances OTC?

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They contain small amount of CS's (primarily C-V) and the FDA feels that a prescription is not required.

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Which states require prescription for CV Substances?

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Colorado and New York

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guidelines for sale of CV's

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- sale made by pharmacist
- 18yrs + identification
- no more than 8 ounces (48 dosage units) in 48 hours for opium containing substances

no more than 4 ounces (24 dosage units) for any other controlled substance in any 48 hr period may be dispensed.

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The pharmacist must maintain record of all such noprescription sales (ex: CV's) in a bound book that contains:

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C-DIP

-name and address of purchaser
-name and quantity of controlled substance
-date of purchase
-initials of dispenser

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Fed regulations provide for 3 methods for filing prescriptions

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3 sep
-CII
-CIII-CV
-all others

2 sep
-CII-CV; CIII-CV must have red "C" lower left
-all others

2 sep
-CII only
-CIII-CV(must have red "C" stamp lower left) + all others

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Requires that each pharmacy registrant make a complete and accurate inventory of all controlled substances every 2 yrs.

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Controlled Substance Act (CSA)

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How many months may the biennial inventory be delayed past the biennial date (May 1)

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6 months

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Second letter of the DEA # corresponds to what?

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Prescribers last name

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Two Limitations of pharmacy technicians

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1) recieve oral prescriptions
2) excercise professional judgement

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If a patient needs additional medication for a CII drug what must happen?

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A new prescription must be issued by the prescriber

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3 safety considerations all pharmacies must have

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PRiM

- number of poision control center in dispensing area

- reference guide to toxicities of ingestion or topical exposure

-MSDS sheets for hazardous materials

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How many years must a poison log be kept?

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5 years

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What must a poison log include after a sale?

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DiPPRoN

- Date of purchase
-Name and address of purchaser
-name and quantity of product
-reason for purchase
-full name of dispenser

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All poisonous substances labels must include:

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- the complete name of poison
-the word POISON boldly printed
- place of business of the seller
- directions for use

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What 2 things should every pharmacy be stocked with for safety when a toxin is ingested

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One once bottles of syrup of Ipecac

Activated Charcoal

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Should be used to induce vomitting (emesis) for noncaustic substances only.

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Syrup of Ipecac

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How can you dilute the caustic effects of an ingested toxin?

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Milk or any other suitable substance

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What is the dose of syrup of ipecac and how often should it be taken if vomiting hasn't occurred?

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15ml (1 tbsp)

every 10-15mins

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Where exposure to the product is not likely to cause adverse health hazard.

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Class III drug recall

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Where exposure to the product will cause a severe health hazard or death.

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Class 1 Drug recall

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ensures a safe and healthful workplace for all employees

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Occupational and Safety Act of 1970

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The Occupational Safety and Health Admin was created to

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- develop job safety standards
- report job related injuries/illnesses
- decrease hazards
- enforce mandatory standards

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Standards that relate to pharmacy practice

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- Air contaminants
- Flammable liquids
- Eye and Skin protection
- Hazard Communication Standard (HCS)

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Each repackaged drug must contain a label with the following:

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SELDoM-G

-generic name
-strength
-dosage form
-manufacturer name + lot #
-expiration date after repackaging

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A repackaging log must include

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- date of prepacking
-name of drug
-manufacturers name
-manufacturers expiration date + lot #
- quantity of drug repackaged
-sig of pharmacist

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Lists all sources of drug products grouped as pharmaceutical equivalents

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Orange Book

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Orange Book
Drug products with this first letter code are considered therapeutic equivalents

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A

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Orange Book
Drugs products w/ this letter code indicate that the products have a documented therapeutic in-equivalence

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B

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federal agency part of Dept of health and human resources which sets national standards for disease control and prevention.

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CDC (Center for Disease Control)

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Provides statistics and info to health professionals on the treatment of common and rare diseases. Primary function is to issue regulations for infection control.

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CDC (Center for Disease Control)