Guide to Federal Pharmacy Law

by Reiss, Barry S.; Hall, Gary D.

• ISBN13: 9780967633237
• ISBN10: 0967633230
• Edition: 4th
• Format: Paperback
• Copyright: 2004-12-01
• Publisher: Apothecary Pr

Table of Contents

Section A	1	(12)
Guide to the MPJE®	1	(12)
Applying for and Taking the MPJE®	1	(2)
Content of the MPJE®	3	(1)
MPJE® Competency Statements	4	(4)
Tips for Answering MPJE® Questions	8	(3)
Common Errors Made By Candidates	11	(2)
Section B	13	(12)
Sources of Laws, Rules and Regulations	13	(12)
Introduction	13	(1)
Pure Food and Drug Act of 1906	13	(1)
Food, Drug and Cosmetic Act of 1938	14	(1)
Durham-Humphrey Amendment of 1951	15	(1)
Kefauver-Harris Amendment of 1962	15	(1)
Medical Device Amendment of 1976	16	(1)
Orphan Drug Act of 1983	17	(1)
Drug Price Competition and Patent-Term Restoration Act	17	(1)
Prescription Drug Marketing Act of 1987	18	(1)
FDA Modernization Act of 1997	18	(1)
Medicare Modernization Act of 2003	19	(3)
Official Compendia	22	(3)
Section C	25	(10)
Acronyms and Definitions	25	(10)
Acronyms	26	(6)
Definitions	32	(3)
Section D	35	(12)
Bringing New Drugs to Market	35	(12)
Investigational New Drug Application (IND)	35	(1)
Clinical Trials	36	(1)
Treatment Investigational New Drugs	37	(1)
The New Drug Application (NDA) Process	38	(1)
Fast Track Products	38	(1)
Abbreviated New Drug Application (ANDA)	39	(1)
Supplemental New Drug Application (SNDA)	39	(1)
FDA Classification System for New Drugs	40	(3)
Orphan Drugs	43	(4)
Section E	47	(34)
Requirements for Marketed Drug Products	47	(34)
Naming New Drugs	47	(1)
Patent Protection	48	(1)
National Drug Code (NDC)	49	(1)
Good Manufacturing Practice (GMP)	50	(1)
Adulterated Drug Products	51	(1)
Product Labeling	51	(1)
Labeling Requirements for Manufacturer's Containers	52	(2)
Listing of Therapeutically Inactive Ingredients on Labels	54	(1)
Package Inserts	55	(1)
Identification of Commercial Solid Dosage Forms	56	(1)
Prescription Drug Marketing Act 1987	57	(3)
Pregnancy Warnings	60	(2)
The STEPS Program for Thalidomide (Thalomid)	62	(1)
The SMART Program for Isotretinoin (Accutane)	63	(1)
Unapproved Use of Drugs	64	(1)
Unit-dose packaging and labeling	65	(1)
Bar Coding of Pharmaceutical Products	66	(1)
Customized Patient Med Paks	67	(1)
The MedWatch Program	68	(1)
Other Product Reporting Initiatives	69	(2)
Drug Recalls	71	(1)
Prescription Compounding vs. Manufacturing	72	(2)
Expiration Dating for Compounded Prescriptions	74	(1)
Compounding of Sterile Products for Use in the Home	75	(6)
Section F	81	(48)
Filling and Dispensing Prescriptions	81	(48)
Federal vs. State Regulations	81	(1)
Authorization to Prescribe	82	(1)
Health Professionals That Self-prescribe	82	(1)
Pharmacist's Obligation to Fill a Prescription	83	(1)
Prescription Refills	83	(1)
Prescription Ownership	84	(1)
Prescription File Storage Period	84	(1)
Labeling of Prescription Drugs	84	(1)
Expiration Dating vs. Beyond Use Dating	85	(4)
Poison Prevention Packaging Act (PPPA)	89	(3)
Federal Anti-Tampering Act (1982)	92	(3)
Patient Package Inserts (PPIs)	95	(1)
Medication Guides	96	(1)
Drug Product Substitution	97	(9)
Narrow Therapeutic Index Drugs (NTI's)	106	(6)
Mailing of Prescription Drugs	112	(3)
OBRA 90 and Patient Counseling	115	(4)
Health Insurance Portability & Accountability Act (HIPAA)	119	(3)
International Commerce Involving Drugs and Drug Products	122	(1)
Out-of-state and Foreign Prescriptions	123	(6)
Section G	129	(96)
Controlled Substances	129	(96)
Definitions Related to Controlled Substances	129	(10)
Registration of Manufacturers, Distributors, and Dispensers	139	(1)
Applications for Registration	140	(2)
Re-registration	142	(1)
Commercial Containers	142	(1)
Schedule I Controlled Substances	142	(6)
Schedule II Controlled Substances	148	(4)
Schedule III Controlled Substances	152	(5)
Schedule IV Controlled Substances	157	(4)
Schedule V Controlled Substances	161	(1)
Excluded (Exempt) Substances	162	(1)
Purchasing or Transferring Schedule I or II Substances	163	(3)
Completing DEA Form 222	166	(2)
Filling Orders Written on DEA Form 222	168	(2)
Ordering Controlled Substances Using DEA Form 222	170	(1)
Endorsing an Order Form	171	(1)
Unaccepted or Defective Order Forms	172	(1)
Lost or Stolen Order Forms	173	(1)
Storage of Order Forms	174	(1)
Cancellation and Voiding of Order Forms	175	(1)
Persons Entitled To Issue Prescriptions	176	(1)
Purpose of Issue of Controlled Substances Prescriptions	176	(1)
Issuing Of Controlled Substance Prescriptions	177	(2)
Persons Entitled To Fill Controlled Substance Prescriptions	179	(1)
Detoxification or Maintenance Treatment	179	(1)
Schedule II Prescription Requirements	180	(2)
What Is An Emergency?	182	(1)
Faxing of Schedule H Prescriptions	182	(1)
Refilling Schedule II Prescriptions	183	(1)
Partial Filling of Schedule II Prescriptions	183	(2)
Labeling Schedule II Prescriptions	185	(2)
Schedule III, IV, and V Prescription Requirements	187	(1)
Refilling of Schedule III, IV or V Prescriptions	188	(4)
Partial Filling of Schedule III, IV, and V Prescriptions	192	(1)
Labeling and Filling of Schedule III, IV and V Prescriptions	193	(2)
Transfer of Prescription Information Between Pharmacies	195	(2)
Dispensing Controlled Substances Without a Prescription	197	(1)
Destruction of Controlled Substances	198	(3)
Transfer of Controlled Substances Between Pharmacies	201	(2)
Controlled Substance Records	203	(3)
Inventory Requirements	206	(4)
Verification of DEA Numbers	210	(1)
Prescribing by Hospital Employees	211	(1)
Mid-level Practitioners (MLP)	212	(1)
Storage of Controlled Substances	213	(1)
Pharmacy Employment Practices	214	(1)
Theft of Controlled Substances	215	(2)
Federal Investigation of Pharmaceutical Theft or Robbery	217	(1)
Required Records	217	(1)
Storing Prescription Information	218	(7)
Section H	225	(13)
Treatment of Narcotic Dependence	225	(13)
Use of Buprenorphine Products	227	(1)
Practitioner Requirements	228	(1)
Practitioner Record Keeping Requirements	229	(1)
Standards for Federal Opioid Treatment Programs	229	(3)
Required Services for OTPs	232	(1)
Prevention of Drug Diversion	233	(5)
Section I	238	(11)
Nonprescription Drugs	238	(11)
General Labeling Requirements	238	(3)
OTC Labeling for Pregnancy and Nursing Mothers	241	(1)
OTC Labeling of Sodium Content	241	(1)
OTC Labeling for Other Electrolytes	242	(1)
Tamper-resistant Packaging	243	(1)
Prescription to OTC Reclassification	244	(2)
Nonprescription Sale of Ipecac Syrup	246	(2)
Nonprescription Sale of Quinine	248	(1)
Section J	249	(6)
Dietary and Nutritional Products	250	(5)
Dietary Supplement Health Education Act (DSHEA)	250	(1)
Official Status of Herbals	251	(1)
Ban on Sales of Ephedra and Ephedrine Alkaloids	252	(1)
Homeopathic Drug Products	253	(2)
Section K	255	(4)
Cosmetics	256	(3)
Section L	259	(8)
Miscellaneous Laws and Regulations	260	(7)
Alcohol Regulations	260	(1)
Americans with Disabilities Act (ADA)	261	(3)
E-mail use in Pharmacy Practice	264	(1)
Drug-free Workplace	265	(1)
Unfair Competition	265	(2)
Section M	267	(77)
Sample Questions	267	(73)
Answers to Sample Questions	340	(4)
Section N	344	(12)
U.S. Boards of Pharmacy	344	(12)
Index	356