1
Q
Food, Drug, and Cosmetic Act
A
- FDCA
- Act passed in 1938 following sulfanilamide elixir deaths
- Primary law governing food, drug, cosmetic, and medical device safety
- Requires new drug be proven SAFE prior to distribution/marketing (New Drug Application)
- Established the FDA
- Authorized FDA factory inspections
- Added FDA injunction procedures
2
Q
1951 Durham-Humphrey Amendments
A
- Created 2 drug classes
- OTC
- Prescription
- Drugs which cannot safely be used without medical supervision
- Authorized verbal precriptions and refills
- Prescription drugs can be dispensed:
- upon written script issued by liscensed practioner
- upon oral script by practioner reduced to writing and filed by pharmacist
- by refilling a written or oral prescription if authorized by practioner either in original script or by subsequent oral order
- by direct administration or dispensing directly by practioner
- Prescription drugs can be dispensed:
- Exempts precriptions from being “Misbranded Drugs” (manufacturer’s labeling requirements) as long as prescription label requirements are met
3
Q
Precription label requirements
A
- Name and address of dispenser (pharmacy)
- Serial number (prescription number) of prescription
- Date of the prescription/filling
- Name of prescriber
- Name of patient
- Directions for use and cautionary statements, if any, contained in the prescription
4
Q
1962 Kefauver-Harris Amendments
A
Following discovery of thalidomide birth defects
- Required new drugs be proven SAFE & EFFECTIVE for their claimed use
- Increased safety requirements for drugs (more clinical investigations)
- Increased and strengthened FDA inspection authority
- Gave FDA jurisdiction over prescription drug advertising
- established Good Manufacturing Practices (GMPs)
5
Q
1987 Prescription Drug Marketing Act
A
- PDMA
- Enacted to reduce potential public health risks that may result from diversion of prescription drugs from legitimate commercial channels
- Bans reimportation of prescription drugs produced in U.S. (except by manufacturer or after FDA approval for emergency use)
- Bans sale, trade, or purchase of prescription drug samples
- Mandates storage, handling, and recordkeeping requirements for prescription drug samples
- Prohibits, with exception, the resale of prescription drugs by hospitals or health care facilities
6
Q
TSBP rules on samples
A
- consistent with federal law
- prohibit most pharmacies from selling, purchasing, trading, or possessing prescription drug samples
- only exception (all 4 requirements must be met):
- pharmacies owned by a charitable organization or a city, state, or county governement owned healthcare entity
- providing care to indigent or low income patients at no or reduced cost
- such samples may only be provided at no charge to patients
- the samples must be in compliance with the 1987 PDMA
- If requirements are not met, the drugs must be destroyed according to TSBP rules
- only exception (all 4 requirements must be met):
- prohibit most pharmacies from selling, purchasing, trading, or possessing prescription drug samples
- Note: PDMA does not apply to OTC drugs and a pharmacy MAY be in possession of sample OTCs
7
Q
2013 Drug Quality and Security Act
A
- DQSA
- Addressed 2 primary topics:
- large scale compounding by pharmacies (DCQA)
- establishment of a framework for a uniform track & trace system for prescription drugs throughout the supply chain (DSCSA)
8
Q
Drug Compounding Quality Act (DCQA)
A
- Part of the 2013 Drug Quality and Security Act
- Maintains state regulation of traditional compounding under section 503A
- Allows facilities that are compounding sterile pharmaceuticals to register with the FDA as an “Outsourcing Facility” under Section 503b of the FDCA
- Outsourcing Facilities that meet FDA requirements are exempt from
- New drug provisions (FDCA Sec 505)
- Adequate directions for use (sec 502 f1)
- Drug track & trace provisions (sec 582)
- Outsourcing facilities (503B facilities) are
- permitted to compound sterile products without recieving patient specific prescriptions or medication orders
- primarily regulated by FDA
- subject to FDA’s current GMPs
- Compounding pharmacies NOT registered with FDA as an outsourcing facility
- referred to as 503A pharmacies/facilities
- may only compound pursuant to an individual precription or medication order
- permitted to do limited anticipatory compounding
- regulated by the state
- subect to USP chapter 797 quality standards for sterile compounding
9
Q
Drug Supply Chain Security Act
A
- Track & Trace
- Part of 2013 DQSA
- Provides for a uniform national framework for an electronic trace & trace system for prescription drugs as they move through the supply chain
- Sets national standards for states to license drug wholesaler distributors
- Traceability applies to prescription drugs for human use in finished dosage form
- blood, blood components, radioactive drugs, imaging drugs, certain fluid replacement IV products, dialysis solutions, medical gases, compounded drugs, medical convenience kits containing drugs, certain combination products, sterile water, and irrigation products are exempt
- Manufacturers are required to provide “Transaction Data” for each product sold.
- Pharmacies are required to recieve transaction data and pass this along if thet further distribute the product
- Transaction data includes:
- Transaction information
- Product’s name
- strength
- dosage form
- NDC number
- container size
- number of containers
- date of transaction
- name & address of person ownership is transferring from AND to
- Transaction History
- paper or electronic statement that includes prior transaction information for each previous transaction back to the manufacturer
- Transaction Statement
- paper or electronic statement by the seller showing:
- seller is authorized (licensed)
- seller recieved product from an authorized (licensed) person
- seller recieved transaction information & history from the prior owner if required
- seller did not knowingly ship a suspect or illegitamate product
- seller has systems and processes to comply with verification requirements
- seller did not knowingly provide false transaction information
- paper or electronic statement by the seller showing:
- Transaction information
- Pharmacies that are “distributing” (providing a drug to anyone other than the consumer/patient as compared to dispensing-which is to patient) must have a wholesale distribution license and must pass DSCSA transaction data with that distribution. Only exceptions to this rule are:
- When the distribution is between 2 entities that are affiliated or under common ownership
- When a dispenser is providing a product to another dispenser on a patient specific basis
- When a dispenser is distributing under emergency medical reasons
- When a dispenser is distributing “minimal quantities” to a licensed practioner for office use
- Other DSCSA provisions will be implemented gradually, eventually requiring electronic track & trace of a product at the individual package level using a unique product identifier on each package by 2023
10
Q
Prohibited acts under FDCA
A
Nearly all violations of the FDCA cause products to be adultered or misbranded. It is important to understand the difference between these two concepts.
dispensing errors could lead to adulteration or misbranding
11
Q
Adulteration
A
- A drug is adultered if
- It contains any filthy, putrid, or decomposed substance
- It has been prepared or held under unsanitary conditions where it may have been contaminated
- The methods of manufacture do not conform to current GMPs
- The container is composed of any poisonous or deleterious substance which may contaminate the drug
- It contains an unsafe color additive
- It purports to be a drug in an official compendium and its strength differs from or its quality/purity falls below the compendium standard (unless the difference is clearly stated on the label)
- It is not in the copmpendium, and its strength differs from or its quality falls below what it represents
- It is mixed or packed with any substance which reduces its strength or quality or the drug has been substituted in whole or in part
12
Q
Misbranding
A
- A drug is misbranded if:
- The label is false or misleading in any particular way
- It is a prescription drug and the manufacturer’s labeling fails to contain the following information
- name & address of the manufacturer, packer, or distibutor
- brand and/or generic name of the drug or drug product
- net quantity (weight, quantity, or dosage units)
- weight of active ingredient per dosage unit
- The federal legend “Rx only”
- If not taken orally, the specific ROA
- special storage instructions, if appropriate
- manufacturer’s control number (lot number)
- expiration date
- adequate information for use (package insert and medication guide or patient package insert if required)
- It’s an OTC drug and doesn’t have
- A principal display panel, including a statement of identity of the product
- name & address of the manufacturer, packer, or distributor
- net quanity of contents
- cautions and warnings needed to protect user
- adequate directions for safe & effective use (in layterms)
- content and format of OTC product labeling in “Drug Facts” panel
- active ingredient
- purpose
- uses-indications
- warnings
- directions
- other information
- inactive ingredients (alphabetically)
- questions? optional followed by phone #
- A drug liable to deterioration must be packaged or labeled accordingly
- A container made, formed, or filled as to be misleading
- A drug that is an exact imitation of another drug or offered for sale under the same name of another drug
- It is dangerous to health when used in the dosage or manner suggested in the labeling
- It is packaged or labeled in violation of the poison prevention packaging act
13
Q
content and format of OTC product labeling in “Drug Facts” panel
A
- active ingredient
- purpose
- uses-indications
- warnings
- directions
- other information
- inactive ingredients (alphabetically)
- questions? optional followed by phone #
14
Q
Product with FD&C Yellow #5 (tartrazine) and #6
A
Must disclose presence and provide warning in “precautions” about possible allergic reaction
15
Q
Aspartame
A
Must contain warning in precautions and label phenylketonurics with ___mg phenylalanine per___ dosage unit
16
Q
sulfites
A
must contain allergy warning
17
Q
mineral oil
A
requires take at bedtime warning
AND
not to be used in infants unless doctor instructed
cannot encourage use during pregnancy
18
Q
wintergreen oil (methyl salicylate)
A
if more than 5% must include warning that use other than directed may be dangerous
AND
keep out of reach of children
19
Q
sodium phosphates
A
requires specific warning
limits amount tp not more than 90 ml per OTC container
20
Q
isoproterenol inhalation
A
requires warning not to exceed dose prescribed and contact doctor if difficulty breathing persists
21
Q
potassium salts for oral ingestion
A
warning regarding nonspecific small bowel lesions consisting of stenosis with or without ulceration associated with administration of enteric coated thiazides with potassium salts
22
Q
Ipecac
A
Boxed and in RED: For emergency use to cause vomiting in poisoning. Before use call physician, poison prevention, or hospital ER immediately for advice
Must warn: Keep of of reach of children. Do not use in unconscious person
dosage must appear. usual dose is 1 tablespoon (15 mL) in individual over age 1
May only be sold in 1oz (30 mL) containers
23
Q
Phenacetin (acetophenetidin)
A
possible kidney damage warning when taken in large amounts or for long period
24
Q
salicylates
A
aspirin and other salicylates must have Reye’s Syndrome warning
retail containers of 1 1/4 grain (pediatric) can’t have more than 36 tablets
25
alcohol warning
internal analgesics and antipyretics (tylenol, aspirin, ibuprofen, naproxen, ketoprofen, etc)
must warn to consult doctor before taking if consumes 3 or more alcoholic beverages per day
26
acetaminophen
must have "acetaminophen prominently displayed
must warn: liver toxicity
must warn talk to doctor or pharmactist if taking other products containing acetaminophen
27
NSAIDs
Must include the term "NSAID" prominently on label
Must warn: "Stomach bleeding"
28
Additional OTC requirements
* tamper evident packaging
* except insulin, dentrifice, dermatological, or lozenge products
* pharmacist repackaging would be subject to cGMPs (manufacturing) and would have to meet all additional requirements including tamper evident packaging
* OTCs prescribed and filled as prescription -do not need OTC labeling...need prescription drug label
29
FDA drug and device recall
* class I- reasonable probability product **will** cause either serious adverse effects on health or death
* class II- **may** cause temporary or medically reversible adverse effects on health or where probability of serious adverse effects is remote
* class III- **not likely** to cause adverse health consequences
Technically FDA doesn't have authority to recall a drug but they DO have authority to recall medical devices. But FDA can take other actions such as product seizures so most companies comply when FDA requests a drug recall
30
Advertising and promotion of prescription drugs
* prescription drug advertising is regulated by FDA
* OTC advertising is regulated by FTC (federal trade commision)
* Prescription Drug price advertising is under FDA regulation but is exempt from regulation if
* purpose is to give price and not safety, efficacy, or indication for use info
* contains brand (if there is one) and generic name, strength, dosage form, and price for specific quantity
* price stated includes all charges to consumer
* mailing and delivering fees may be stated separately
31
PPIs
* Patient package inserts
* supplied by manufacturer and in layman terms
* required to be given when dispensing
* oral contraceptives
* estrogen-containing products
* hospitalized/institutional patients-
* must be provided PPI prior to first administration and every 30 days thereafter
* Failure to give PPI for these drugs causes MISBRANDING
32
Medication Guides (MedGuides)
* Similar to PPI w/o requirements for hospital/institutional patients
* required when
* Patient labeling could prevent serious adverse effects
* product has serious risks relative to benefits
* patient adherence to directions is crucial
* must be written in standard format and language suitable for patients
* manufacterers need FDA approval before distributing guide and are responsible pharmacies are provided a sufficient number
* Over 300 products require a medication guide -complete list is on FDA site under drug safety
33
REMS
* Risk Evaluation and Mitigation Strategies
* manage known or potential serious risk associated with a drug or biological product
* FDA requires if they find it necessary to ensure benefits of a drug or biologic outweigh the risks
* REMS can include
* a MedGuide
* Patient Package Insert
* communication plan
* elements to ensure safe use
* special training, experience or certification of prescribers
* special certification for pharmacies, practioners or healthcare settings dispensing drug
* dispensing only allowed in certain healthcare settings
* dispensing only to patients with evidence or documentation of safe use conditions such as lab test results
* monitoring patients using the drug
* enrolling each patient in a registry
* an implementation system
* MUST include a timetable for assessment of the REMS
* REMS example-iPLEDGE for isotretinoin (Accutane)
* only iPLEDGE doctors can prescribe
* only iPLEDGE patients can take
* only iPLEDGE pharmacies can dispense
* 30 day supply is max, no refills allowed
34
NDC code
10 digit code identifies manufacturer or packager (labeler), prodcut, and package size
first 4-5 digits: labeler
next 3-4: specific drug
last 1-2: package size
\*nearly all drug products have NDC BUT NDC does not indicate is drug is FDA approved
35
FDA orange book
* Approved Drug Products with Therapeutic Equivalence Evaluations
* primary source for generic equivalence
* Use 2 letter code to indicate equivalency
* A-Products FDA considers pharmaceutically and therapeutically equivalent
* B-NOT considered pharmaceutically and therapeutically equivalent
* No known or suspected bioequivalence issues
* AA-conventional dosage forms
* AN-solution/powder for aerosolization
* AO-injectable oil solution
* AP-injectable aqueous solution
* AT-topical
* AB-products with actual or potential bioequivalence problems but evidence has established bioequivalence
36
FDA purple book
* Lists of Licensed Biological Products...
* biological prodcuts that are considered biosimilar and provides interchangeability evaluations
* only "interchangeable" products may be substituted by a pharmacist in Texas
37
Poison Prevention Act
* Requires child-resistant containers for all prescription and OTC drugs
* Exceptions
* request of patient or prescriber
* bulk not for hosehold use
* drugs distributed to institutionalized patients
* OTC drugs designed for elderly
* oral contraception, congugated estrogens, northindrone acetate
* medroxyprogesterone tablets
* sublingual nitro
* effervescent aspirin or acetaminophen
* potassium in unit dose packages
* anhydrous cholestyramine and colestipol packets
* preparations in aerosol containers intended for inhalation
* pancrelipase preparations
* sucrose in glycerol and water
* hormone replacement that needs one or more progestogen or estrogen substance for activity
38
betamethasone amount to not need child resistant package
betamethasone with 12.6 mg per package or less
39
isosorbide child resistant
sublingual/chewable isosorbide 10 mg or less
40
sodium flouride child resistant
sodium flouride with less than 264 mg/package
41
erythromycin suspension child resistant
erythromycin for oral suspension granuales and suspensions with 8g or less
42
erythromycin tablet child resistant
erythromycin tablets in packages with 16g or less
43
prednisone child resistant
prednisone tablets in packages with 105mg or less
44
methylprednisolone child resistant
methylprednisolone with 84mg per package or less
45
mebendazole child resistant
mebendazole with 600 mg or less per package
46
MPJE
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