Code of ethics = what ought to be

Law = what must be

1. Constitution

2. Treaty

3. Statutes

4. Regulation

____ an agreement between or among nations.

___are laws passed by state or federal legislatures

___ are administrative enactments of the executive branch of government that fulfill statutory policies and procedures.

1. Copyright laws

2. Sales > $500

3. Marriage contracts

4. Sale or transfer of lands

5. Contracts with terms lasting > 1year

6. Contracts that answer for debt or duty of another (surety)

1. Real estate     2. financial (credit cards, loan)

3. Family law: divorce, will     4. Employment                5. PBM contracts   6. Purchasing or selling a business.  

7. Purchasing or providing goods/services

Who can enter into a contract?

1. Adults: >18 yrs old

2. Mentally competent

3. Corporations (via their agents/employess)

1. Offer

2. Consideration

3. Acceptance

The 1906 Federal Food and Drug Act was considered Inadequate because:

• False statements made about a drug by a manufacturer were held by the courts not to be misbranding
• The act did not extend to cosmetics
• The act did not grant the authority to ban unsafe drugs
• Labels were not required to identify contents

The first attempt to control specific class of drugs (i.e. narcotics) lead to International Opium Convention of 1912

and creation of this law.

 1) OTC and Rx status

2) How prescription drugs were to be dispensed

3) oral prescriptions and written prescriptions,

4) refills

5) dispensing directly by a practitioner

This Amendment was passed after Thalidomide disaster and it focuses on drug efficacy amendments, such as:

1. Proof of effectiveness

2. Proof of safety

3. Good manufacturing practices (GMP)
4. Drug advertising

5. Investigational drug procedures 

This Act covers rare diseases or conditions  that affects less than 200,000 persons in the US or one that affects more than 200,000 persons in the US and for which there is no reasonable expectation of recovering the development costs from the drug's sales in the United States. 

This Act lead to:

• Abbreviated New Drug Applications (ANDAs)
• Patent Life extension for up to 5 years for patent life lost during FDAs regulatory review process
• Decreased time necessary to obtain approval for generic drugs

This Act lead to these policies:

• Amended the FFDC Act to reduce the potential public health risks that may result from diversion of prescription drugs from legitimate commercial channels
• Bans sale, trade, or purchase of samples (including community pharmacy)
• Mandates storage, handling and record-keeping requirements for drug samples
• Prohibits, with certain exceptions, the resale of prescription drugs purchased by hospitals or health care facilities

Establishes criminal and civil penalties for violations of the Act

• This Act defines "claims" that manufacturers are allowed to make regarding a dietary supplement

This Act did the following:

• Pediatric studies of drugs
• Pharmacy compounding
• Positron Emissions Tomography (PET) Compounding
• Expediting Study and Approval of Fast Track Drugs
• Information Program on Clinical Trials for Serious or Life-Threatening Diseases

Elimination of Certain Labeling Requirements: "RX only" vs. Federal Legend; "Warning---May be habit forming (use of this phrase repealed)

Requires a new, easy-to-read, standardized format for OTC drug information

Over-the-Counter Labeling Requirements (1999)

• The ____provides for the marketing of "non-complying" packages or regulated substances other than prescription drugs in order to facilitate access to regulated products by the elderly and handicapped 

According to the Poison Prevention Package Act of 1970 (PPPA) It is necessary to package all ____ products, with certain exemptions in safety closure containers, and OTC drugs if they are dispensed as a prescription.

This Act established the:

1. Drug Review Programs by states

2. Retrospective Review Board

•       ____ also requires states to establish standards governing patient counseling. 

___ is also known as the Kennedy-Kassebaum Act, which in Title II includes provisions that authorize the Department of Health and Human Services to promulgate several sets of rules that apply to pharmacies, including:

·         Privacy rules

·         Security rules

·         Transaction ad code sets rules

·         Identifier rules

What is the purpose of the Security Standards?

What are Transaction and Code Sets Rules?

The proposed transaction rule requires the creation of a standard format that will be used even if the transaction is on paper, by phone, of by fax.

What are the Unique Identifier Rules?  

• Identifier rules will establish uniform numbers for patients, providers, health plans, and employers to help those entities identify and communicate with each other.

1. Devices are recognized in the ___, or the ____ or any supplement to them 

Official National Formulary

or 

United States Pharmacopeia

1. Legends or prescription

2. OTCs

3. Controlled substances

1. Dependency

2. Psychological dependency

3. Public health risk

Adulterated drug = has something physically wrong with the drug ex. physical damage, change in color, bad smell etc.

Misbranded drug: false info on the label of the drug

Class I Recall: product cause serious or fatal consequences.

Class II Recall: drug or device cause serious but reversible health effects.

Class III Recall: product are not likely to cause adverse health consequences.

1. Injunction or restraining order from court (civil procedure)

2. Seizure or embargo (civil procedure)

3. Regulatory letter (administrative action by FDA)

1. Isoproterenol

2. Contraceptives and estrogen products:

a. oral contraceptive

b. after-sex contraceptives

c. Injectable contraceptives (Mederoxyprogesterone acetate)

d. Estrogens

e. Progestational drugs

1. When drug arrives at the pharmacy (Record of Acquisition - invoice from wholesaler)

2. Drug sits in pharmacy shelve (Inventory)
3. Drug is leaves pharmacy (Prescription or sale record) 

• It contains a new chemical substance for medical
• It is an established drug offered in a new dosage form
• It is an established offered with new medical claims
• It is an established drug offered at new dosage levels
• It is an established drug packed in a new or novel packaging material