PTCB Exam 2022: Federal Requirements
Manufacturer Drug Labeling
1. Name and place of business of manufacturer, packer, or distributor. 2. National Drug Code number. 3. Adequate directions for use. 4. No misleading statements. 5. Statement of ingredients. 6. Prominence of required label statements. 7. Spanish-language version of certain required statements. 8. Expiration date. 9. Manufacturer lot or control numbers. 10. Declaration of presence of FD&C Yellow No. 5 or No. 6 in certain drugs for human use 11. Declaration of presence of phenylalanine as a component of aspartame in OTC and prescription drugs. 12. Prescription drugs containing sulfites, required warning statements. 13. Labeling for systemic antibacterial drug products. 14. Bar code label requirements. Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile.
Practitioners with Full Prescribing Authority
1. physicians (MD, DO) 2. Podiatrists (DPM) 3. Dentists (DMD, DDS) 5. Vets ( DVM)
Schedule I Controlled Substances
A HIGH ABUSE POTENTIAL AND "NO ACCEPTED MEDICAL USE"
Schedule IV Controlled Substances
Mild abuse potentials leading to: -Mild physical/psychological dependence
Schedule IV (C-Iv) Drugs
Some Depressants, Mixed Opioid Agonist/Antagonists, Stimulants
Schedule V (C-V) Drugs
Some Opioids, Depressants
Schedule III (C-III) Drugs
Some Opioids, Mixed Opioid Agonist/Antagonists, Stimulants, Depressants, Anabolic Steroids, Hallucinogens
Schedule II (C-II) Drugs
Some Opioids, Stimulants, Depressants, Hallucinogens
Schedule V Controlled Substances
Substances in this schedule have a low potential for abuse-consist primarily of preparations containing limited quantities of certain narcotics.
Poison Prevention Packaging Act of 1970 (PPPA)
• Designed to reduce the risk of children ingesting dangerous substances. • Required locking caps on most prescriptions
HIPPA
-Health Insurance Portability and Accountability Act of 1996 -protects the privacy and security of patient medical records and information
DEA Verification
-add the 1st, 3rd, 5th numbers (X). -add the 2nd, 4th, and 6th numbers (Y). -multiply Y by 2 to get a new Y -add X and new Y . the last number of X+Y should equal the last digit of the DEA number
*OTC* drugs must contain:
1) Display panel, including statement of identity of the product 2) Name and address of manufacturer, packer, or distributor 3) Net quantity of contents 4) Cautions and warnings needed to protect the user 5) Adequate directions for safe and effective use (for layperson) 6) "Drug facts" panel must include: active ingredients, purpose, use(s) - indications, warnings, directions, other information, inactive ingredients, Questions? followed by Ph# [OTC's without approved application (monograph drugs) require domestic address or domestic Ph# to receive reports of serious adverse events; drugs with Mg, Ca, Na, or K that might be harmful to certain pts must have stated exact amount]
Practitioners with Limited Prescribing Authority
1. Optometrists (OD) 2. MID-level practitioners (PA's, and NP) - a licensed physician must approve every prescription written by a mid-level practitioner
Schedule III Controlled Substances
Abuse potential leading to: - MODERATE or LOW physical dependence - HIGH psychological dependence
DEA Form 224
Application for DEA registration
FDA Recalls
Class I - reasonable probability that product WILL cause serious AE's/death Class II - MAY cause temporary health consequences, but probability is REMOTE Class III - NOT LIKELY to cause adverse health consequences
Which is the most serious type of FDA recall?
Class I Recall
Federal Controlled Substances Act (CSA)
Establishes a "closed system" of inventory and accounting for distribution of controlled substances 5 Schedules (I, II, III, IV, V) - based on likelihood of abuse Listed chemicals (precursors to controlled substances)
Vitamins and herbal supplements are classified as
Food substances
Schedule I (C-I) Drugs
GHB, heroin, LSD, marijuana, MDMA
Schedule II Controlled Substances
High abuse potential leading to: - SEVERE physical dependence - SEVERE psychological dependence
Is AD5251872 a valid DEA Number?
No. the 1st, 3rd, and 5th number = 18 the 2nd, 4th, and 6th number = 10 10x2= 20 18+20=38 2 does not equal 8
DEA Form 222
Order form for CI and CII substances. Must be kept for 2 years.
DEA FORM 224a
Renewing DEA registration (Every 3 years)
DEA Form 41
Reporting destruction of controlled substances
DEA Form 104
Reporting pharmacy closure or surrender of pharmacy permit
OSHA
The agency in the Department of Labor to maintain a safe and healthy work environment
The DEA
The agency that enforces the federal Controlled Substance Act (CSA) and classified drugs as controlled substances.
The FDA
The agency that is responsible for determining if a food or drug is safe and effective enough to be sold to the public.
DEA Form 106
To report the lost or theft of controlled substances
DEA Form 222a
Used to order 222 Forms
Is AD1234210 a valid DEA Number?
Yes. the 1st, 3rd, and 5th number = 6 the 2nd, 4th, and 6th number = 7 7x2=14 14+6=20 0 = 0
Federal Trade Commission (FTC)
a federal agency established in 1914 to investigate and stop unfair business practices (advertising)
Federal Food, Drug, and Cosmetic Act (FFDCA)
a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics.
The Drug Addiction Treatment Act of 2000 (DATA 2000)
allows prescriber to obtain waiver to prescribe CIII, CIV, and CV for treatment of opioid addictions
The State Board of Pharmacy
establish state specific pharmacy laws and regulations
Misbranded Recall
problems with labeling: false, misleading, insufficient
Adulterated Recall
problems with product: strength, quality, or purity
Omnibus Budget Reconciliation Act of 1990 (OBRA '90)
requires pharmacist to perform DURs and offer counsel to Medicaid patients (Try to remember the phrase "Oh... Bruh!" Like something is wrong and you need to call your friend to answer or fix something)
