Chapter 1 Intro to Govt and the Law:
Branches of the Government:
 Legislative Branch:
- Makes laws
- Contains Congress (which is made up of the senate and house of representatives
o Congress has power to regulate commerce (Interstate Commerce Clause)
 Executive Branch:
- Enforces laws, power to veto bills
- Includes the president
 Judicial Branch:
- Interprets laws using:
o Statues and laws
o Rules and regulations
o Past Cases
Hierarchy (after Constitution):
 Federal statutes
 State constitutions
 State legislation
 ordinances
Amendments/Constitution:
 Amendment 14: gives the right to be heard by a court/judge (equal protection and due process)
 Article 1 Section 8: Commerce clause allows the govt to regulate healthcare
Administrative Agencies (4th Branch of Govt.):
 Created to oversee complex matters of the govt.
 Passes rules & regulations  they are NOT laws bur they do have the “force of the law”
Chapter 2 The FDA
FDA:
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Safeguards the safety, effectiveness, and integrity of the nation’s drug supply
FDA CDER (Center for Drug Evaluation and Research):
 Evaluates new drugs before they can be sold
 Provides physicians and pt’s w/ necessary info via the package insert
 Ensures health benefits outweighs risk for medications
 Monitors drugs after reaching the market
 Reviews the data of clinical trials and the labeling of the drug
 Conducts limited research in quality, safety, and efficacy (current good manufacturing practices)
 Prescription Drug User Fee Act of 1992 (PDUFA):
- Drug companies pay fees to increase FDA resources; FDA agrees to time goals for review of NDAs
 Orphan Drug Act of 1983:
- Manufacturers allowed to market exclusively for 7 years
 Best Pharmaceuticals for Children Act of 2002:
 Investigational New Drug (IND):
- Must show FDA preclinical testing in animals in order for the company to continue on w/ the process
o Phase 1: healthy volunteer; emphasis on safety; how drug is metabolized; 20-80 pts
o Phase 2: small number of pts w/ the condition; emphasis on effectiveness; involves a control product
o Phase 3: larger scale studies; effectiveness in different populations; different doses and combination w/
other medications; involves a control product
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o Phase 4: post-marketing studies- data used to determined a products continued safety, efficacy, and use
New Drug Application:
- Includes all animal and human data and analysis; how drug works in body, how it’s manufactured
- Benefits of drug must outweigh risk
Institutional Review Board (IRB): approves clinical trial protocol
- Type of pt, schedule of tests, medications and dosages to be studied, length of study, study objectives, assures pts
are informed of their risks, protects pts from harm
Accelerated Approvals:
- Allows a NDA to be approved for drugs intended to treat serious life-threatening illnesses that lack satisfactory
treatments
Quality of Clinical Data:
- They make sure that hospitals w/ investigational drug studies are following the rules set in place
- Conducts inspections of clinical investigation study sites
FTC (Federal Trade Commission):
 Oversees OTC medications
 Durham-Humphrey Amendment: made OTC and Rx drugs
 NDA can request OTC status
Abigail Alliance for Better Access to Developmental Drugs vs Von Eschenbach:
 Mission was to make potentially life-saving investigational therapies readily available to pts w/ cancer and other lifethreatening illnesses
 The ruling of the court stated that pts have no right to “a potentially toxic drug with no proven therapeutic benefit”
MedWatch:
 FDA’s safety info and ADR reporting program
 Voluntary for HCP and pts to report to
 Report via web, phone, or fax
Chapter 3: Federal Drug Control Law
Food, Drug, & Cosmetic Act:
 Regulates all drugs introduced into interstate commerce
 Protects against adulterated or misbranded foods, drugs, cosmetics, or devices
Pure Food & Drug Act of 1906:
 Prohibited adulteration & misbranding of foods and drugs
 Products did NOT need to be effective
1938- Sulfanilamide Elixir Tragedy:
 The company who sold the elixir didn’t get in trouble for the drug not being safe… they got in trouble for misbranding
 Because of this- labels now had to contain directions for use with warnings
Durham-Humphrey Amendment of 1951:
 Made legend and nonlegend drugs
 Amendment restricted the sale of legend drugs to prescription by a licensed practitioner
 RPh’s were able to take Rx orders over the phone
 All Rx stock bottles had to be labeled saying “Caution: Federal law prohibits dispensing w/o a prescription”
Kefauver-Harris Amendment of 1962:
 Required drugs to be proven safe and effective
 Applied to both RX and OTC drugs
 Gave FDA jurisdiction over drug advertising
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Established Good Manufacturing Practices (GMP) requirements
Enacted worldwide due to Thalidomide disaster
Orphan Drug Act of 1983:
 Tax and exclusive licensing incentives for manufactures to develop and market drugs that were too expensive to
develop for diseases that affect only a few people
Drug Price Competition and Patent-Term Restoration Act of 1984 (Waxman-Hatch Amendment):
 Streamlined the generic drug approval process to make generic drugs more readily available to the public, but at the
same time to provide incentives for manufacturers to develop new drugs by possibly extending patent life
Prescription Drug Marketing Act of 1987:
 Made selling of samples by doctors and pharmacists illegal; recordkeeping for handling of samples
 Drug wholesalers now had to be licensed
 Banned reimportation of Rx drugs by anyone besides the manufacturer
 Prohibited resale of Rx drugs purchased by hospitals and other health care facilities
 Banned counterfeiting of drug coupons
Prescription Drug User Fee Act of 1992 (PDUFA):
 Helped shorten the drug approval process by making drug companies pay the FDA to review their drug applications
Dietary Supplement Health and Education Act of 1994 (DSHEA):
 Defined what dietary supplements are (more like foods than drugs)
 They could not make claims to treat/cure/prevent diseases
Food and Drug Administration Modernization Act of 1997:
 Regulated medical devices
 Increased the FDA’s public accountability
 Fast track approval for drugs used to treat serious/life threatening diseases
 Established databank of info on clinical trials
 Authorized scientific panels to review clinical investigations
 Allowed manufactures to disseminate unlabeled use information
 Expanded the FDA’s authority over OTC drugs
 All inactive ingredients had to be listed on the labels of all medications
Label: info displayed on the container or wrapper
Labeling: includes the label and the info accompanying the drug, such as PI
GMP: set of regulations that establishes minimum requirements for the methods, facilities, or controls used in the
manufacture, processing, or packaging, or holding of a drug product
 Manufactures must be registered w/ the FDA and be inspected once every 2 years for compliance w/ GMP
Section 301 of the FDCA:
 No food, drug, device, or cosmetic may be introduced into interstate commerce if it’s been adulterated or misbranded
 The same goes for receipt or manufacturing of adulterated or misbranded products
 Prohibited the alteration, mutilation, destruction, or removal of whole or any part of the labeling of a product
Section 501 of the FDCA:
 Says that a drug or device shall be deemed to be “adulterated” if: it kept in filthy conditions, contains a decomposed
substance, if it’s been held, packed, or prepared under unsanitary conditions or if the manufacture doesn’t follow
GMPs, or if it contains a color additive which is unsafe.
 It’s adulterated if it isn’t up to USP standards, differs in strength or quality/purity that what it says on the label
Section 502 of the FDCA:
 A drug or device shall be deemed “misbranded” if it’s labeling is false or misleading
 It’s misbranded if the label doesn’t contain the name and place of business of the manufacturer, packer, or distributor;
and an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count
 It’s misbranded if any info required isn’t prominently place on the label or if the amount of each active ingredient isn’t
posted, or if any inactive ingredients aren’t labeled.
 It’s misbranded if it’s missing adequate directions for use and warnings against use
 If it’s not stored under proper conditions (amber, air-tight vial) when it needs to be
 It’s misbranded if when used in the dosage or manner in which is recommended by the label is dangerous to health
 It’s misbranded if advertisements lack info on ADRs, CIs, and effectiveness
 It’s misbranded if it’s packaging or labeling is in violation of the Poison Prevention Packaging Act of 1970
Adequate Directions for Use:
 Quantity or dosage for each intended use and for persons of different ages and physical conditions
 The frequency and duration of use, time of administration, the route or method of administration, and the preparation
necessary for use (shaking, dilution)
 Drug that cannot be labeled adequately to protect the consumer are classified as prescription drugs
Enforcement of the FDCA:
 Can make the violator stop its illegal activity and bring criminal proceeding against violators
 Can seize any violating products
 Can request recalls
 Can inspect manufacturer sites
 Can send warning letters to the public
Product Recalls:
 FDA can request a “voluntary” recall as an alternative to seizure
 Class I Recall: occur when there is REASONABLE probability that the product WILL cause serious, adverse health
consequences or death
 Class II: recalls occur when product MAY cause temporary or medically reversible adverse health consequences
 Class III: apply to products that are NOT likely to cause adverse health consequences
Pharmacy Label Requirements:
 Name & address of dispenser, serial number, date of Rx or its filling, name of prescriber, name of patient, directions for
use and cautionary statements
 Federal law does NOT require name of drug
New Drug:
 Any drug not generally recognized as safe or not generally recognized as effective
 Must have an approved NDA to have a new drug in interstate commerce
Dietary Supplements: DSHEA:
 Mandates FDA to regulate dietary supplements more as a special type of food than as a drug
 Cannot say its intended to diagnose, cure, mitigate, treat, or prevent disease
 Manufacturer can make a structure or function claim if they can substantiate it, but can’t make a therapeutic claim
Generic Drug Products:
 requires a NDA, must show product is essentially identical to brand name drug
The Orange Book:
 Bioequivalence: products display comparable bioavailability (rate and extent of absorption)
 Therapeutic equivalence in the orange book means the same as bioequivalence (not same class, different drug)
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- A = products are bioequivalent
- B = products are NOT bioequivalent
Therapeutic Equivalence-Related Terms:
Pharmaceutical Equivalents: drug products are considered equivalents if they contain the same active ingredient(s),
are of the same dosage form, route of administration are identical in strength or concentration.
Pharmaceutical alternatives: they contain the same therapeutic moity, but ate different salts
Bioavailability: the rate and extent (kinetics)
Bioequavalent Drug Products: describes pharmaceutical equivalent or alternative products that display ccomparable
bioavailability when studied
Labeling of Prescription Drugs:
 Package Insert- written for HCPs
 Patient Package Insert: certain drugs require info to be distributed to the patient (NSAIDs)
Unit Dose Label Requirements:
 Name of drug, quantity of active ingredient, expiration date, lot number, name of place of business
Federal Anti-Tampering Act:
 OTC’s must contain a visual seal/barrier on products to show if it has been opened/tampered with (exception include
lozenges, insulin, dermatologics)
Poison Prevention Packaging Act of 1970:
 Enforced by the Consumer Product Safety Commission
 Requires that most OTC and RX drugs be placed in child-resistant containers (80% of children <5 can’t open them,
whereas at least 90% of adults can)
 Drugs can only be dispensed one time in a child-resistant container or vial  if the vial is glass, then only a new lid is
needed
 Act allows manufactures to market 1 size of OTC product in noncompliant packaging
The Omnibus Budget Reconciliation Act of 1990 (OBRA 90):
 Deals w/ practice standards for pharmacists; goal is to reduce health care costs for govt.
 Includes “pharmaceutical care”: pharmacists produce therapeutic outcomes and improve a pt’s quality of life
- Rebates: requires manufacturers to provide meds to Medicaid at their “best price” through rebates
- Demonstration Projects: to determine if RPh’s provide cost-effective services
- DUR: retrospective review, educational programs, prospective review
o A screen of Rx’s before dispensing
o Pt. counseling by RPh
o RPh documentation of relevant info
Health Insurance Portability and Accountability Act of 1996:
 Regulates the privacy and security of health info
 All prescribers would receive a NPI number
 Pharmacy can use and disclose HI for: treatment, payment, and operations (audits)
Medicare:
 Part A: covers medical supplies and rental of medical appliances
 Part B: partially covers outpt diagnostic services
 Part C: managed care
 Part D: drug coverage
Medicare Prescription Drug, Improvement, and Modernization Act of 2002 (MMA):
 drug benefit: pays 75% after a $250 deductible, up to an initial coverage limit of $2250, dough-nut whole, then after
$3600 out of pocket will pay 95%
 E-prescribing
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All plans must have a MTM program and be developed by MDs and RPhs
Chapter 4 The Drug Enforcement Administration
The Controlled Substances Act:
 Deals with the regulation of manufacture, import/export, distribution and dispensing of controlled substances
 Is a “closed” system, only those registered w/ the DEA may handle CS
 The DEA, under the department of justice is in charge of enforcing the CSA
 All people in legit chain of manufacture, distribution, or dispensing of CS must register
Classification of Controlled Substances:
 Narcotic: a natural or synthetic opium or opiate and any derivative thereof
 The attorney general has the authority to place an unscheduled drug into a schedule, switch a drug to a different
schedule, or remove a drug from scheduling
 Before changing anything, the attorney general must have the health and human services do an evaluation and give an
opportunity for a hearing
 CII-CIV require a “caution” statement of the label
- Schedule I: lack of accepted info on safety; can only be used for research purposes
- Schedule II: abuse can lead to severe physical or psychological dependence
o No time limit under federal law of when they must be filled
o No quantity limit on CIIs
o May fax in Rx to expedite filling, but still need original hardcopy of Rx
o Faxes may be used as the original if the drug is to be compounded and for direct administration to the pt,
for pts in LTCFs, for pts residing in hospices (must document on Rx “hospice pt”)
- Schedule III: moderate or low physical dependence or high psychological dependence (ex: anabolic steroids)
o May not contain more than 1.8g of codeine per 100mL of 90mg per dosage unit; 500mg of opium per
100mL or 25mg per unit; 50mg of morphine per 100mL or 100g.
- Schedule IV: limited physical dependence or psychological dependence (benzodiazepines, Phenobarbital,
phenteramine)
o May not contain more than 1mg of difenoxin and not less than 25mg of atropine per dosage unit
- Schedule V: abuse may lead to limited physical/psychological dependence relative to schedule IV
o May not contain more than 200mg of codeine per 100mL; 2.5mg of diphenoxylate or 0.5mg of difenoxin
AND not less than 25mg of atropine per dosage unit
o OTC products have a limit of 240mL or 48 units of opium substances; 120mL or 24 units of other controlled
substances w/in 48 hr time frame (purchaser must be 18, have ID, must document)
Registration:
 Manufacturers and distributors must register annually
 Pharmacies register every 3 years
 Public health service, Bureau of prisons personnel, and military personnel DON’T need to register
- DEA form 224: to obtain DEA registration
- 224a: renewal application for registration
- 224b: retail pharmacy registration covers all the chain pharmacies
Transfer of Controlled Substances:
 CII transfer require DEA form 222
 CIII-CV: must be documented in writing
Destruction: can obtain authorization to destroy once a year; use DEA for 41
To Report a Loss: use DEA form 106
Record Keeping Requirements:
 Purchased, received, distributed, dispensed, otherwise disposed of
 Maintain records for 2 years
 CIIs: kept separate
 CIII-CV: separate or readily retrievable
 DEA form 222: used for receipt and sale of CIIs and/or transfer
 Once you receive your CS order, must document on copy 3
 Old order forms, prescriptions and inventory records CAN’T be kept centrally
 A red “C” should be stamped not less than 1 inch high in the lower right-hand corner
 When doing the inventory of controlled substances you must document: inventory date, time taken, drug name, and
dosage form
Corresponding Responsibility Doctrine: both the prescriber and the pharmacist are legally responsible for the proper
prescribing and dispensing of controlled substances
CII Emergencies:
 The RPh may dispense a CII on oral authorization provided that:
- Quantity is limited to amount necessary to treat the pt for the emergency period
- Pharmacist makes good faith effort to verify if Dr. is not known to them
- The prescriber must send a hard copy Rx w/in 7 days to the pharmacy. The Rx must say “Authorization for
Emergency Dispensing”
- RPh must attach written & oral Rx together
 Emergency Situation defined as:
- Immediate administration of the CS is necessary for the proper treatment of the pt
- No appropriate alternative treatment is available
- It is not possible for the prescriber to provide a written prescription before dispensing
Partial Filling of a Schedule II Rx:
 Balance must be filled w/in 72 hours after partial filling
 LTCF scripts can be partially filled for up to 60 days of the issuance
 RPh must record “terminally ill” or “LTCF pt”
 For each partial fill, must document date, quantity dispensed, remaining quantity authorized to be dispensed and ID of
the pharmacist
Narcotic Treatment Programs (NTP): methadone can be used outside of program for PAIN only
Chapter 5 Federal Controlled Substances Law
Addict: any individual that habitually uses any narcotic drug in which it endangers the public’s safety, morals, health or
welfare, or who is so far addicted to the use of narcotic drugs as to have lost the power of self-control with reference to his
addiction
Deliver: a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner,
including the prescribing and administering of a controlled substance or a listed chemical, whether or not there exists an
agency relationship.
Practitioner: includes pharmacy and hospital
Individual practitioner: dentist, vet, MD… (does not include pharmacist)
CI: a drug or substance that high potential for abuse and no current accepted medical use, can’t be prescribed, and there is a
lack of accepted safety for use of the drug or other substance under medical supervision….. Ex: Heroin
CII: High abuse potential w/ medical uses, but those issues are restricted, abuse may lead to severe mental and physical
dependence Ex: morphine
CIII: currently accepted medical use; abuse potential low to moderate physically but high psychologically, can be dangerous Ex:
steroids
CIV: low abuse potential, abuse can lead to limited physical & psychological dependence Ex: librium, phenobarbital,
benzodiazepines
CV: low abuse potential; limited physical & psych dependence Ex: cough syrup w/ codeine, atropine
Registration:
 Annual for: every person who manufactures or delivers
 Every 3 years for: pharmacies
 Who Requires Registration?
- Researchers of narcotics (CI-V)
- Dispensers
- Reverse distributer
- Distributor (if >5% of sales are controlled substance)
- Each pharmacy
- Manufacture of narcotics
- Exporting of controlled substances including exporting for chemical analysis
- Drug abuse treatment centers
- Physicians
 Pharmacies need to register as a distributor if: 5% of total units of controlled substances distributed in 1 yr
 Pharmacies need to register as manufacturers if: they prepare solutions or solid dosage forms containing a narcotic
controlled substance exceeding 20% of the completed product.
Records:
 Need to be kept for 2 years
 Schedule II: prescriptions must be an original hardcopy except in a LTC facility, hospice, or home infusion
 Schedule III-IV: filled or refilled and cannot be refilled more than 6 months after the date was written (or 5 times)
 Schedule V: no time limit on refills, some need Rx and others are beyond the counter
DEA Registration Number:
 1st letter will be either A, B, or F
 2nd letter is the first letter of the practitioner’s last name
 DEA # Formula:
- Add 1st, 3rd, & 5th numbers
Add 2nd, 4th, 6th numbers and multiply by 2
Add result from #1 and 2, the second digit is the same as the last digit of the DEA number
DEA Form 106:
 Filled out to report loss of controlled substances
 Must Report the following:
- Which schedule is missing
why it’s missing, volume of drug the store goes through (is there a mistake w/ the number)
- How often are the numbers off (1 x a year or multiple times a yr)
- If a robbery occurred
- Quantity missing
- Was it reported to the local police
- Report it even if you don’t know if the loss is significant (caution on the side of error)
- Where the meds were in the pharmacy (abc vs mixed in not in abc order)
Things That Can’t be Kept at a Central Location:
 Used 222 forms
 Rx records for controls
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Inventory records
Controlled Substances on Hand = inventory + records of received – records of dispensing
 Inventories must be initialed and be biannually
 Must be taken at beginning of the day or at end (must document when)
 New pharmacies must do an inventory before opening their doors and then done every 2 years
 Newly controlled substances must be inventoried on the effective date (tramadol)
 CIIs need an exact count
 CIIIs-IV can be estimates unless the stock bottle is >1000 count- then you have to count it
DEA Form 222:
 Info Required on it:
- supplier name & address, date, # of packages received, quantity in bottle, name of product, and signature
 To sign it: power of attorney is required
 Call DEA to get more order forms
Requirements for Controlled Substance Rxs:
 Physicians are NOT allowed to write a controlled substance prescription for office use
 Maintenance treatment: for a drug addiction must be through a drug treatment program or the narcotic must be used
for another condition other than an addiction (ok to use suboxone)
 RPh must receive a original or verbal script (if verbal- a hardcopy script must also be received w/in 7 days for CIIs)
 Drug name, dosage form, strength, quantity, directions, refills, DEA number, prescribers name and address, signed,
dated for when it was issued (does not apply to LTCF as long as no more than a 7 day supply is dispensed)
 The nurse may prepare the Rx as long as the physician signs it
 If anything is missing on the Rx and it can’t be verified  it can’t be filled
LTCFs:
 Retail pharmacies are allowed to put automated dispensing units in LTCF (a separate registration/DEA number is
required)
 Hospice pts, direct administration to a pt in a LTCF don’t need hardcopies for CII Rxs
 Partial filling is allowed but the remaining portion must be filled w/in 72 hours
 LTCF or terminal pts can receive partial quantities (up to maximum qty) w/in 60 days  must document on Rx that pt
is “terminally ill” or “LTCF Pt”
CII Rxs:
 After contacting prescriber, may change the strength, quantity, directions, dosage form, or patient address
(document!)
 CAN’T change the pt’s name, the drug, or signature
Transferring CIII-V Rxs:
 Transfer: 1 time
 Chain transfer (CVS to CVS): doesn’t count
 Documentation: same info as a valid rx + name of old pharmacy, “void” must be written on the face of the invalidated
prescription, you must record on the reverse side of the invalidated rx the name, address and DEA number of the
pharmacy to which it was transferred to and the name of the pharmacist receiving the rx information.
 The pharmacist receiving the rx must write “transfer” on the face or the transferred Rx
CV Rxs:
 Required for C5: 18 yrs old, ID, signature, valid medical need for the drug,
 Qnty limits per 48 hrs: opium 8oz. , non-opium: 4oz, no more than 48 dosage units of any such controlled substance
containing opium, nor more than 24 dosage units of any other such controlled substances may be dispensed at retail
to the same purchaser in a given 48 hour period.
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Pseudophed 3.6g/day/transaction and 9 gms per 30-day period
Can’t seel >7.5 grams ephedrine base, pseudoephedrine base, or phenylpropanamine base per customer in a 30-day
period
7.5 g w/in 30 days
Blister packed, no more than 2 doses in a blister
Don’t need a signature if purchase is < 60mg
Log book kept for 2 years,
Photo id, signature, date, address
If you falsify  federally accountable
Pharmacy must register
Medical Treatment of Narcotic Addiction:
 Narcottics/opiod treatment programs must register w/ DEA, have limited amount of drugs they can use, other meds
not used for addiction need a physician order
 The DEA promotes a new program that governs regulations that permit the prescribing of CII-V for the treatment of
the disease of addiction, as long as the prescribed drug has been approved for that purpose by the FDA.
Chapters 6-7 Illinois Pharmacy Act:
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Pharmacists are allowed to provide vaccination of pts 14 years of older
Dispensing: the interpretation, evaluation, and implementation of a prescription drug order, including the preparation and
delivery of a drug or device (doesn’t include administration to the pt)
Compounding:
 Compounding excludes flavoring
 Even if the compound is for demonstration purposes only…it’s still considered compounding
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Pharm techs may take medication histories, ask about allergies, and offer counseling
After you pass the Naplex, you must apply for your license
MTM services may be provided w/ or w/o the filling of an Rx