Federal and Illinois Law for MPJE Flashcards
1
Q
Controlled Substances Act of 1970
A
- Gave FDA authority to determine the scheduling of controlled substances
2
Q
Controlled Substances Closed System of Distribution
A
Access to controlled substances are restricted through REGISTRATION and SCHEDULING.
3
Q
Registration of Controlled substances
A
All who come in contact with controlled substances must be registered (or employed by a registered entity) except the PATIENT who has a LEGITIMATE medical needed for medication and accesses it through a VALID RX.
4
Q
Scheduling of Controlled Substances
A
Substances that have the potential for abuse or can cause addiction are scheduled into one of 5 schedules.
5
Q
What happens if a patient no longer needs the controlled substance medication? Can they return it to the pharmacy?
A
NO! It has LEFT the closed distribution network when it was dispensed to the patient.
6
Q
What are the exceptions that allow a controlled substance to be returned to the pharmacy?
A
- When there has been a dispensing error
7
Q
Who is permitted to be an authorized collector of controlled substances? Who Isn’t?
A
Is: Manufacturers; distributors; reverse distributors; narcotic treatment programs; hospitals/clinics with and onsite pharmacy; and retailed pharmacies.
8
Q
If they are only registered to handle controlled substance schedules III-V; are they allowed to be an authorized collector of CS?
A
NO a registrant but also be registered to handle CII CS to qualify
9
Q
How can an authorized collector take back CS?
A
- Maintaining collection receptacles
10
Q
How can a patient or authorized collector destroy CS?
A
The regulations do not require a particular method of destruction. Only that the CS but be rendered “non-retrievable”. This allows for a variety of destruction methods as long as they are secure; convenient; responsible; and consistent with preventing diversion.
11
Q
What does “non-retreivable” mean?
A
Permanently altered CS physical or chemical condition or state through irreversible means and thereby renders the CS unavailable or unusable for all practical purposes. Basically; when there is no way it can be transformed back into the CS
12
Q
Can law enforcement agencies take back CS?
A
Yes. No DEA registration is required for law enforcement agencies either.
13
Q
Is a patient required to bring back their CS to an authorized collector?
A
Nope. A patient is permitted to destroy the substance themselves.
14
Q
Most important CS registration categories for the MPJE
A
- Manufacterer
15
Q
Dispenser registration for CS
A
Applies to physicians or a mid-level practitioners as there is no such thing as a “prescriber” registration.
16
Q
Can IL and Federal registration be limited by schedule? Class?
A
Yes. A practitioner can have a DEA registration for only CIII-CV CS. It can also be limited to drug class (narcotic vs non-narcotic)
17
Q
Application for CS is divided into the following categories
A
- II Narcotic
18
Q
Under Federal Law what is a Narcotic
A
- Opium; opiates; derivatives of opium/opiates. (does not include isoquinoline alkaloids of opium)
19
Q
How does Illinois Law define a Narcotic?
A
The exact same way as federal Law.
20
Q
Owner; when applying for DEA CS registration; is defined as
A
- The “sole proprietor”
21
Q
Power of Attorney when applying for DEA CS registration; is defined as
A
- A registrant may authorize one or more individuals; whether located as the registered location or not; to issue orders for schedule I and II CS on a DEA form 222;* on the registrants behalf by executing a POA for such individual.
22
Q
Who must execute a Power of Attorney?
A
Must be executed by the person who signed the most recent application for DEA registration (or re-registration); the person to whom the POA is being granted to; and TWO WITNESSES
23
Q
Who can be given Power of Attorney?
A
ANYONE including pharmacists; non-pharmacist owners; technicians; pharmacy interns; and even unlicensed persons. It is PREFERRABLE that only the pharmacist handle CS ordered.
24
Q
Pharmacies must register with the DEA under which registration? Do individual pharmacists need to register as well?
A
a Dispenser of CS. One registration covers all CII-CV substances. Employee pharmacists do not need to obtain a second registration.
25
DEA form 224/224a
224: initial registration as dispenser
26
How often do federal DEA registration's for dispensers expire?
Renewal is required every three year.
27
Can one dispenser registration cover multiple pharmacies owned by one person or entity?
No a separate registration is needed for each pharmacy owned or operated by the same entity.
28
Does the POA need to be a pharmacist?
No. However; under state (IL) law; the ordering; securing; and dispensing of CS is the responsibility of the PIC; regardless of whether the PIC is the registrant; and regardless of whether the PIC has POA.
29
What does granting some POA do?
It allows then to execute federal order forms to obtain schedule II CS. (DEA FORM 222)
30
How are Hospital registrations different?
Hospitals register "institutional practitioners" which allows employee practitioners; nurses; and pharmacists the authority to possess; prescribe; dispense; and administer CS. It also allows CS to be stored anywhere in the registered location.
31
Is a separate registration required for the hospital pharmacy?
NOPE
32
Is an institutional practitioner registration also available to clinics?
Yes as long as they are licensed under state law.
33
When would you need multiple registrations?
1. Location: registration required for each site with a different street address.
34
When must a pharmacy register as a distributor?
1. It participates in joint buying activites and is the location in which drugs are stored and shipped to other pharmacies..
35
When must a pharmacy register as a manufacturer?
1. It purchases CS for purposes of repacking for sale within a pharmacy w/o a Rx
36
When must a pharmacy register as a detox compounder?
1. compounds CS for sale or distribution at NTP for purposes of addiction tx. (NTP must also be registered wit DEA).
37
DEA form 225/225a
Manufacturers; wholesalers; importers; exporters; and researchers register with DEA form 225 and renew with 225a (every 3 years).
38
When can the DEA deny an application?
1. Falsified info in application
39
When can the DEA revoke an application?
1. Same reasons as it can deny the application and
40
Does IL require a separate CS registration through the state of IL?
YES; separate registration required for dea; state of IL; and the pharmacy or practitioners state professional license. Need all three in order to dispense
41
Requirements for IL CS registration
1. Proof of federal registration
42
When does IL CS registration expire?
Registration expires on date certificate holders pharmacy license expires (march 31 of even years).
43
Does the practitioner's state registration have to appear on a prescription?
NO just the DEA number; but they (and the pharmacy) must possess both registrations.
44
DEA Registration number
series of two letters followed by seven numbers
45
DEA Registration: A/B/F/G
Hospital/Clinic/Practitioner/Teaching Institution/Pharmacy (G has been added for department of defense practitioners)
46
DEA registration: M
Mid-Level practitioners
47
DEA registration: L
Reverse distributors
48
DEA registration: P/R
Manufacterer/distributor/researcher/analytical lab/importer/exporter/reverse distributor/narcotic treatment program
49
DEA registration: X
Practitioner in the treatment of addictions on an outpatient basis. This is issued and used IN ADDITION TO the A; B; F; or G DEA number
50
How do you verify a DEA number?
• add the 1st; 3rd and 5th number
51
Schedule I definition
High potential for abuse
52
Schedule I examples of drugs
Heroin
53
Schedule II definition
High potential for abuse which may lead to severe psychological or physical dependence
54
Schedule II; examples of drugs?
Narcotic Analgesics
55
Schedule III definition
Potential for abuse less than substances in schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence
56
Schedule III examples of drugs
Anabolic steroids
57
Schedule IV definition
Low potential for abuse relative to substances in Schedule III. May lead to only a limited physical or psychological dependence
58
Schedule IV examples of drugs
Anxiolytics; sedatives
59
Schedule V definition
Low potential for abuse relative to substances listed in schedule IV
60
Examples of Schedule V drugs
products containing not more than *10* mg of codeine per 100mL or per 100grams are considered CV
61
General rules for scheduling drugs
Short acting and/or quickly absorbed products are more prone to abuse
62
What is the entry point for newly scheduled controlled drugs?
CIV; but in reality drugs are placed in permanent schedule by the time it is approved for marketing
63
Can CV CS be dispensed with out a prescription?
IL and federal permit a pharmacy to sell certain CV without a prescription.
64
How much CV CS can you buy without a Rx according to federal law?
up to 4 oz
65
Illinois Law on dispensing CV codeine products without Rx
No more than 120 mL or 120 grams of a CV which contained codeine; dihydrocodeine; or any salts thereof in any 96 hour period
66
IL vs Federal CV Exempt Products: Age requirement
IL: 21 y.o. + 2 forms of ID
67
IL vs Federal CV Exempt Products: Time limitation
IL: 96 hours
68
IL vs Federal CV Exempt Products: Records
IL: Signature of purchaser; certification of no purchases w/in 96 hours; time of sale; and signature of RPh.
69
IL vs Federal CV Exempt Products: Reporting
IL: maintain records for 2 years and send copy of IDPR by 15th of next month
70
IL vs Federal CV Exempt Products: Possession limits
IL: no more than 4.5 L per drug product plus amount of products needed for dispensing during busiest week
71
IL vs Federal CV Exempt Products: Refills if Rx
IL: Max of 5 refills or 6 mo
72
In IL who can sell an except CV product?
only a pharmacist. they must complete the log book and verify the age of the seller; etc. Anyone can ring up the sale though once this transaction is complete.
73
In IL ephedrine (EPH) and pseudoephedrine (PSE) are scheduled?
CV CS
74
convenience packages of ephedrine are defined as what quantity
360 mg or less of EPH or PSE in liquid or liquid-filled capsule form
75
Where can convenience packages be sold?
May be sold by non-pharmacy retailers as long as the requirements of the law are met
76
What are targeted packages?
Any package; including convenience packages; containing ANY amount of a methamphenatime precursor
77
What if a patient has a valid Rx for a EPH or PSE?
Valid prescription is exempt from these limitations.
78
Sale Limits on EPH or PSE
1. No more than 7500 mg of EPH or PSE in a 30 d period (and pharmacy/employees cannot dispense more than this in a 30d period to any single person)
79
Sale restrictions of EPH and PSE
1. Considered CV
80
ID requirement of EPH and PSE
1. Must provide drivers license or government issued ID showing purchasers name; DOB; and photograph
81
Recordkeeping requirements of EPH and PSE
Purchasers must sign an log including their name; address; date and time of transaction; brand; product name; and quantity of PSE/EPH distributed. To be kept for not less than 2 years for retail distributors and 4 years for pharmacies.
82
Product placement for PSE and EPH
1. Must be behind pharmacy counter
83
Not more than 1.8 g of codeine per 100 mL or not more than 90 mg per dosage unit with:
CIII
84
Not more than 300 mg of ethylmorphine per 100 mL or not more than 15 mg per dosage unit with
Schedule III:
85
Not more than 500 mg of opium per 100 mL or per 100 g or not more than 25 mg per dosage unit with:
Schedule III:
86
Not more than 50 mg of morphine per 100 mL or per 100g with:
Schedule III:
87
Not more than 200 mg codeine/100 mL/g
schedule V
88
Not more than 100 mg of dihydrocodeine per 100 mL/g
CV FEDERAL
89
Not more than 10 mg of dihydrocodeine or any of its salts per 100ml/g
CV ILLINOIS LAW
90
Not more than 100 mg of ethylmorphine per 100ml/g
CV
91
Not more than 2.5 mg diphenoxylate and not less than 25 ug atropine per dosage unit
CV
92
Not more than 100 mg of opium per 100mL/g
CV
93
Not more than 0.5 mg difenoxin and not less than 25 ug of atropine per dosage unit
CV
94
Compounded products containing any amount of dihydrcodeinone/hydrocodone
CII
95
Can any compounded product be considered an exempt narcotic?
NOPE
96
DEA form 222
-must be used whenever Sch I or II drugs are bought; sold or transferred between pharmacies or qualified distributors
97
How many DEA 222 forms can you receive?
Max of 6 order form books; each containing 7 numbered blank forms. Each form contains 10 lines. only 1 item per line with no alterations or erasures.
98
DEA form 222 must include:
Name of drug
99
When CII drugs are received a the registrant; POA; or any person designated by the registrant or POA must:
verify all drugs ordered have been received
100
How long is the sheet where the items received; recorded; and signed and dated is filed for?
2 years
101
How long is the form active if a CII is not received
60 days. Order can be completed any time in those 60 days. if not received within 60 days; item is voided and new order must be placed.
102
DEA 222 may be refused because:
-improperly completed
103
Where do each copy of DEA 222 forms go to? what color are they?
1&2 go to supplier; Pharmacy keeps 3. Supplier retains 1 and forwards 2 to DEA by close of the month during which the order was filed. If order is filled by partial shipments; it must be forwarded at the close of the month during which the final shipment is made or the 60 day validity period.
104
CSOS
Controlled Substance Ordering System - allows pharmacies to order CI and CII substances electronically and replace paper 222 forms
105
PKI
using a technology called Public Key Infrastructure - CSOS requires that each individual purchaser enroll with DEA to acquire a csos digital certificate.
106
CSOS Benefits:
Ordering freedon: no line limit per single order; can also be used for CIII-VI; not just CI-II
107
DEA audit of CSOS
One-time; independent; third party audit of any vendor's software for CSOS purchaser or supplier functions to certify that it preforms the necessary PKI functions. No routine audits unless problem arrises
108
Acquiring CII's from other pharmacies
1. Only in emergency situations
109
ABC Pharmacy borrows supply of OxyContin fron a neighboring pharmacy: which forms?
1: neighboring pharmacy
110
Returning a C2 from ABC pharmacy to Neighboring pharamcy
1: ABC
111
Lost or stolen DEA forms 222
1. if forms are lost in transit and not received; new form should be submitted
112
IL CII duplicate order requirement (Pentazocine (Talwin) only)
1. Requires written order; in duplicate; containing the following info:
113
Ordering CIII-CV substances
No special form required.
114
CS Prescription Content requirements
1. Signed and dated on time of ISSUANCE
115
Pre-printed prescriptions: controlled drugs
IL Law does not allow pre-printed rx. "pre-printed" means a written rx in which the drug name has been indicated prior to the time of issuance. (if they are not prepared in advance of the time that the patient is seen by the practitioner).
116
Do computer generated rx that are printed out or faxed need to be signed?
Yes they need to be manually signed
117
Are faxed prescriptions considered electronic rx's?
NO
118
Persons authorized to issue CS rx's
Federal law defers to state law
119
Prescribing under hospital DEA number
Interns; residents; and foreign-trained physicians may if:
120
If a hospital resident is practicing outside of the hospital can he still use the hospital DEA number
NO; if he is working from outside the hospital he must have is own; or have permission from the other hospital he is at to the that facilities DEA nubmer
121
Can residents prescribe CII's?
YES; there are no limitations on the prescriptive authority for a resident or other physician who is operating under a hospital's DEA registration
122
Prescribing for a Legitimate purpose ("good faith")
Federal: must be for a legitimate medical purpose by a prescriber acting in the usual course of his professional practice; if not it is illegal.
123
Pharmacist's corresponding responsibility for illinois/federal good faith standard
Means dispensing of CS which in a rph's professional judgement is lawful. Will look at:
124
Federal vs IL: Self-prescribing CS
Fed: allows
125
Federal vs IL: Quantity limit on CS
Federal: no limit
126
Federal vs IL: Prescribing CS to immediate family members
Federal: allowed
127
Federal vs IL: prescribng non-CS to immediate family members
Federal: Allowed
128
CII rx's must be:
WRITTEN; no verbal or fax unless an exception applies
129
Time Limitations on CII's
Fed: no time limit
130
Quantity limit on CII's
Fed: No limit
131
How can you send a CII rx to a pharmacy
Original written; hand signed rx.
132
When can a rph take a CII rx over the phone? Federal Law
Emergency Situations (all 3):
133
When can a rph take a CII rx over the phone? IL Law
- Situations that might result in Loss of life or intense suffering. The quantity dispensed must be limited to amount needed during emergency period.
134
What happens if the rph does not get the written rx within 7 days?
Must notify DEA and Illinois department of human services; office of alcoholism and substance abuse; or the emergency dispensing authority is voided
135
Facsimile Prescriptions
- C III-V and non controls may serve as prescription
136
Electronic Rx's of CII's
Law permits as long as requirements are met. Pharmacy cannot process electronic rx for cs until its application provider obtains a third party audit or certification review that determines the app complies with the DEA's requirements and *the application provider gives the audit/certification report to the pharmacy*.
137
Information that can be changed on a CII Rx: Federal
After consultation with prescribing dr pharmacist may change:
138
Information that cannot be changed on a CII rx: ILLINOIS
- date written OR ADD THE DATE
139
Multiple/"sequential" CII rx's for same drug on same date
A practitioner may provide individual pts up to three (3) 30 day supply rx's for the same CII; written all on the *same day*; to be filled sequentially over the course of 90 days.
140
Requirements for Multiple/"sequential" cII rx's
- Each has a legitimate medical purpose issued by a practitioner practicing in the usual course of practice
141
Post-Dating CII rx's
PROHIBITIED. State and federal law require that all rx's for CS "be dated of; and signed on; the day when issued"
142
Can a pharmacy accept a rx with a future date on it?
NO. They cannot even Hold the RX until the date of fill if it WAS accidentally postdated (even by one day)
143
ALL (CII-CV) CS Prescription Requirements
- dated and signed on day issued
144
Patient ID for proper filling
Sex field is a verifying element of patient ID
145
Partial Dispensing of CII
Comprehensive Drug Addiction and Recovery Act of 2016 allows 30 days to complete partial refil; IL requires 72 hours for complete fill; however; for terminally ill and LTCF patients; can partial fills as many times as needed as long as they are recorded and must be completed within 60 days;;; for emergency CII scripts; 72 hours also applies in IL
146
Partial Refills for CIII-CV
Partial fills are permitted. Each partial fill should be recorded on RX. Six month time limitation still applies.
147
Do partial fills count as refills?
NO but the partial fill should be recorded on the prescription until the full amount is dispensed; then it will be considered a refill.
148
Transferring CS RX's
Limited to one time transfer. Under federal law transfer of CS RX can only occur for purposes of refills. Original RX cannot be transferred.
149
Who can transfer a CS rx?
PHARMACIST ONLY EVEN ELECTRONICALLY
150
Physical transfer of CS rx: Transferor
-Transferor must write VOID on face of rx; record on reverse side the name; address; and DEA# of which it is transferred too; and name of RPh receiving info; and record date and name of RPh transferring information.
151
Physical Transfer of CS Rx: Receiving RPh
-Must write TRANSFER on face of rx and record:
152
How long must transfer CS rx's records be filed?
Fed: two years
153
Labels for CS Rx's
Fed:
154
Rx Filing Systems
File 1 - all CII
155
Record Keeping: Federal law
CS records must be maintained for 2 years
156
Record Keeping: IL Law
Requires all rx records (dispensing and purchasing) to be maintained for FIVE YEARS
157
Central Record keeping is allowed if
invoices and financial data for controls may be maintained at a central location if
158
Computerization of prescription information
Allowed for CIII-V
159
Inventory requirements
Biennially (every 2 years).
160
Requirements of the inventory record
Name of drug
161
Inventory Requirements in IL
Every licensee shall conduct and *annual* inventory with an actual hand-count for CII's and approximate inventory for CIII-V. Inventory maintained for period of 5 years.
162
Disposal of controlled substances: Return to supplier
If CII; use form 222. For CIII-V; DEA recommends maintain written record showing:
163
Disposal of CS: Send to Reverse Distributor
Entity registered by DEA and state law. It takes CS from pharmacy for disposal. Same records must be maintained (CII = 222; CIII-V: written record)
164
Disposal of CS: By Pharmacy
Disfavored by DEA
165
Disposal of CS by Pharmacy Steps
1. Written request to DEA proposing date and method of destruction ; and listing names of at least two people who will witness destruction
166
Disposal of CS by Pharmacy: IL Law
DEA regulations provide an exception to DEA authorization for destruction:
167
DEA Form 106
report of theft or loss of controlled substances
168
Notification to DEA after theft or loss
within *one* business day of discovery of theft or significant loss of CS; a pharmacy must contact nearest DEA diversion field office by telephone; facsimile; or a brief written message. Pharmacy should also notify local police.
169
How to complete DEA form 106
Send original and a copy to DEA diversion field office. Must include:
170
How to identify "significant loss"
- CSA regulations do not define it
171
Who can file a DEA 106?
Under the Illinois Pharmacy Practice Act; the PIC must file the 106.
172
What if PSE is stolen or has a significant loss in stock?
Only schedule substances under FEDERAL law require reporting to DEA. PSE is not CS under federal law so you note NOT required to report that to DEA with form 106.
173
Ryan Haight Online Pharmacy Consumer Protection Act
- Law provides that it is illegal under federal law to deliver; distribute; or dispense CS by means of internet unless online pharmacy holds a modification of DEA registration authorizing it to do so.
174
Definition of online pharmacy
Any person; entity; or internet site; whether in the US or abroad; that knowingly or intentionally delivers; distributes; or dispenses; or *offers or attempts to deliver; distribute; or dispense* a CS by means of the internet
175
Examples of online pharmacy
-Any person who pays someone to write rx's for the website
176
Online Pharmacy Registration Exceptions
- Manufacturers or distributors registered; who do not dispense CS to non-registrants
177
Emergency Medical Kits: Federal Law
-Pharmacy may place an EMK with CS in a non-dea registered long term care facility (LTCF); if the appropriate state agency or regulatory authority specifically approves the placement and procedures that delinate:
178
Emergency medical Kits: Illinois Law
May maintain EMK if permitted by DPH standards for the facilities particular level of care:
179
Narcotic treatment program
a program engaged in maintenance and/or detoxification treatment with narcotic drugs
180
Maintenance tx under narcotic tx programs
Dispensing; for a period in excess of 21 days; of a narcotic or narcotic drugs in the treatment of an individual for dependence on heroin or other morphine-like drugs
181
Detoxification treatment under narcotic tx programs
the dispensing; for a period not in excess of 21 days; of a narcotic drug in decreasing doses to an individual in order to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic drug-free state within such period of time.
182
Can a patient be prescribed methadone for analgesic purposes if they are on methadone for detoxification?
NO ABSOLUTELY NOT
183
Can methadone be prescribed for analgesic purposes if patient is not undegoing maintenance or detoxification treatment?
YES
184
Drug Addiction Treatment Act
This act allows authorized physicians to treat drug addiction with buprenorphine (subutex/suboxnoe) in office based practice where pharmacist dispenses drugs without requiring a separate registration. (is a waiver given to them by DEA). .
185
Use of methadone outside a Narcotic treatment program
A practitioner may not prescribe methadone or any other narcotic medication soley for the tx of a patients narcotic addiction.
186
Controlled Substance Prescription Monitoring Program
- Replaces old "triplicate" requirement for CII Rx's
187
How often to report to the IL PMP?
All information must be transmitted not later than the end of next business day after the date which the CS was dispensed.
188
How often Do LTCF's have to report to IL PMP?
Transmit patient med profiles to PMP MONTHLY or more frequently if established by administrative rule. used for addressing oversite requirements
189
Exceptions for reporting to IL PMP
1. Inpatient orders
190
Is it required to review IL PMP before each CS is prescribed or dispensed?
NO it is only mandatory to REPORT DISPENSING OF CS
191
What is Medication Shopping?
When you intentionally seek any controlled substance while being supplied them from another prescriber or pharmacy
192
What is Pharmacy Shopping?
It is fraud to obtain a CS from a pharmacy while being supplied with any CS by another pharmacy without disclosing.
193
Mailing of CS Prescriptions
CS Prescriptions may be sent by:
194
Does the FDA regulate the practice of pharmacy?
NO that is left to the states.
195
When are pharmacies directly impacted by the Food; Drug; and Cosmetics Act (FDCA)
1. when a pharmacy's compounding activities crosses the line; and they are viewed as manufacturing drugs
196
What does the FDA regulate?
Food; drugs; cosmetics. Does not regulate the practice of medicine or pharmacy.
197
Foods
Dietary supplements
198
FDA Drugs:
Prescription
199
Biologics
Vaccines
200
Medical Devices
Simple items like tongue depressors
201
Electronic products that give off radiation
Microwave ovens
202
Cosmetics:
Products applied to the face; skin; or hair to improve appearance.
203
Veterinary products
Livestock feeds
204
Virus-Toxin Law of 1902
Diphtheria vaccine "contaminated with tetanus;" law requires licensing ...; inspections ...; and pre- market approval ...
205
Food and Drug Act of 1906
- Prohibited interstate commerce in adulterated or misbranded food; drinks; and drugs.
206
Federal Food; Drug; and Cosmetic Act of 1938
- Compelled manufacturers to demonstate SAFETY of new drugs PRIOR to marketing
207
Durham-Humphrey Amendment of 1951
• Created a distinction between "OTC" and "Legend Drugs".
208
Kefauver-Harris Amendment of 1962
• Also known as the "Drug Efficacy Amendment".
209
Medical Device Amendment of 1976
Action of law: provides for
210
Anti-Tampering Regulations
- Cosmetic liquid oral hygeine products; vaginal products; contact lens solutions and most OTC drugs need to be tamper resistant.
211
Orphan Drug Act of 1983
- Drugs intended for the tx of rare disease and conditions
212
Prescription Drug Marketing Act (PDMA) of 1987 and ammended in 1992
Amends the FDCA to:
213
Prescription Drug User Fee Act of 1992 (PDUFA)
Allows FDA to collect fees from drug manufacturers to fund the new drug approval process
214
Nutrition Labeling and Education Act of 1990 (NLEA)
-Allowed use of FDA-approved health claims on food labels
215
Dietary Supplement Health and Education Act of 1994 (DSHEA)
- Vitamins; herbs; and minerals are exempt from food additive provisions
216
Food and Drug Modernization Act of 1997 (FDAMA)
- Fast track approval for certain new drugs and innovative devices by exempting certain devices from pre-market notification requirements
217
Product Registration requirements
If a drug manufacturer or repackagers fail to register with FDA; their products are deemed to be misbranded
218
Do pharmacies have to register with the FDA?
NO. If they are in conformance with local law and do not manufacture; prepare; propagate; compound; or process drugs or devices for resale other than in the regular course of their business of dispensing or selling at retail.
219
a drug is a substance which is
-recognized in the USP; NF or homeopathic pharmacopoeia OR
220
Three KEY POINTS to drug classification
1. No distinction between rx and otc
221
Definition of dietary supplement
- Think of as "food" products
222
Definition of Prescription Drugs
- Cannot be made safe by including adequate directions for use
223
Non-Prescription Drug Definition
- Drugs which are recognized by experts to be safe and effective
224
What is the drug law most likely to be violated by Pharmacists?
Durham Humphrey Ammendment which provides drugs can be dispensed:
225
Misbranded Drugs
Drugs which are sold; dispensed; or distributed in violation of the labeling requirements of the FDCA are misbranded. IL and Federal law consider it misbranded if:
226
Adulterated Drugs
Failure of a drug or device to satisfy FDA purity standards. A drug is deemed adulterated if:
227
Good Manufacturing Practices and Compounding
- GMP refers to standards by which drugs are to be manufactured; processed; and packaged
228
For office use only compounds in IL
- No longer permitted
229
What is anticipatory compounding?
rph compounds small amounts of drug before receiving a rx; based on previously filled valid rx's; within an established practitioner-patient-rph relationship; and the rx is kept on file.
230
Can you sell a compounded product OTC?
NOPE; FDA would view that as manufacturing.
231
Can a pharmacist compound commercially available products?
A rph is permitted to compound a drug that differs slightly from a commercially available product in response to an individual patient's medical need that the rph has documented after consulting pt's physician.
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Drug Quality and Security Act (DQSA)
Attempts to strike balance between "traditional" compounding and non-patient specific compounding
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503a - Traditional Compounding
- if done properly is exempt from FDCA NDCA; cGMP; and labeling requirements
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503B outsourcing facility
- Large scale compounders can elect to register with FDA as an outsourcing facility; strictly voluntary
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USP 797 vs cGMP
USP 797: the standart followed by 503A; adopted by most states in pharmacy practice laws and regulations
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Repackaging of OTC products
Repackage label must contain same info required for commercial product:
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Seizure definition: removing drugs from the market
FDA may "seize" drugs which are "misbranded" or "adulterated". The physical isolation of a drug while the fda or state agency files a civil lawsuit
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Recall: removing drugs from the market
The correction or removal and notification to the company; of a product which is in violation of the law. Three levels of recall
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Class I Recall
Recall class where there is a reasonable possibility that the use/exposure to a violative product will cause serous adverse effects on health or death
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Class II Recall
use or exposure will cause temporary/reversible adverse health consequences; or where proability of harm is remote
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Class III Recall
Not likely to cause any serious adverse effects
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Drug Approval Process
Step 1: In vivo animal studies (Pre-clinical data"
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Step 1 of Drug approval Process
In vivo animal studies - Primarily evaluate pharmacology and potential toxicities. Once complete; sponsor submits an investigational new drug application (IND)
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Step 2 of drug approval process
IND - Contains pre-clinical data; proposed use and safety data; and proposed plan for study in humans. Data is reviewed by FDA; and decision is made whether to allow sponsor to begin in human trials.
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Step 3 of Drug approval process: Clinical Trials
Phase I: Small group of healthy subjects (~20); evaluation of toxicological; pharmacokinetic; and pharmacologic properties; assessment of safety in humans
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Step 4 of drug approval process
NDA: New drug application. Presents FDA reviewers the entire history of development of the drug products. FDA reviews data and determines whether product meets criteria for marketing in US
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Treatment IND
Drug in phase 2 or 3 with some safety and efficacy evidence can be given to pts who are in imminent life threatening stages of an illness w/ no cure.
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New Drug Application Process
All data concerning efficacy; safety; stability; production methods; packaging; and data from clinical trials are submitted to FDA for review.
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Phase 4 studies
Post Marketing Surveillance - monitor use of drug for additional info on safety and efficacy. Manufacturer collects data; and submits *yearly* reports to the FDA.
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aNDA
Abbreviated New Drug Application
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sNDA
Supplemental New Drug Application
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Requirement for Package inserts in estrogens
Each estrogen drug product restricted to rx distribution; including products containing estrogens in fixed combo's; shall be dispensed to patients with a package insert containing information information concerning the drug's benefits and risks.
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Distribution requirements of estrogen products
The manufacturer and distributor shall provide a patient package insert in or with EACH PACKAGE of the drug product that the manufacturer or distributor intends to be dispensed to a patient.
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Estrogen injectable multi-dose vial distribution requirements
A sufficient number of patient labeling pieces shall be included in or with each packaage to assure that one piece can be included with each package or *dose* dispensed or administered to every patient.
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Estrogen distribution requirements for hosptials and LTCF's
Package insert provided to the patient before the first estrogen and every 30 days thereafter; as long as therapy continues
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Patient Package Insert contents for Estrogen
- Name of drug
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Estrogen-Progesterone contraceptives
Labeling requirements set by oral contraceptive section and not estrogen section
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Oral Contraceptive requirement for patient package insert and distribution requirements
Same as estrogen
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Contents of Package Insert for Oral Contraceptives
- name of drug
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Ipecac Syrup Labeling Requirement
Available in 1 oz quantities and label bears the following in a prominent and conspicuous manner:
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OTC products with salicylates labeling
-"Keep out of reach of children; in case of overdose; contact poison control".
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NDC Drug Code Numbers
Series of 10 or 11 digits.
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Pregnancy Category A
Adequate; well controlled studies reveal no risk to fetus during 1st; 2nd; or 3rd trimesters of pregnancy
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Pregnancy Category B
-No adequate; well controlled studies have been conducted in women
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Pregnancy Category C
- Safety of the drug during human pregnancy has not been established; and animal studies are either positive for fetal risk; or have not been conducted.
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Pregnancy Category D
- Positive evidence of risk to human fetus; based mainly on ADR date from investigational or marketing experience.
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Pregnancy Category X
- Studies in animals; or reports in pregnant women; indicate that the risk of damage to the fetus clearly outweighs any possible benefit to the pregnant woman.
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Pregnancy and Lactation Labeling Rule
Now requires package insert to have a separate pregnancy; lactation; and females and males of reproductive potential sections that lays out risk summary; clinical considerations; and data to those populations.
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Tamper-Resistant Packaging
An OTC drug product (except dermatological; dentifrice; insulin; or lozenge product) for retail sale that is not packaged in tamper-resistant packaging or that is not properly labeled under this section is adulterated; misbranded; or both.
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Regulation of Alcohol
- Alcohol is regulated by the federal bureau of alcohol; tobacco; and firearms
