LAW EXAM Study
For individuals 16 years of age or older:
1. A driver's license or identification card containing a photograph, issued by a state or an outlying possession of the United States. If the driver's license or identification card does not contain a photograph, identifying information shall be included such as: name, date of birth, sex, height, color of eyes, and address; 2. School identification card with a photograph; 3. Voter's registration card; 4. U.S. military card or draft record; 5. Identification card issued by federal, state, or local government agencies or entities. If the identification card does not contain a photograph, identifying information shall be included such as: name, date of birth, sex, height, color of eyes, and address; 6. Military dependent's identification card; 7. Native American tribal documents; 8. United States Coast Guard Merchant Mariner Card; 9. Driver's license issued by a Canadian government authority.
If this method is used, a prescription for a schedule III, IV or V drug must be made readily retrievable by use of a red "C" stamp not less than one inch high.
1. A file for all schedule II controlled substances dispensed. & 2. A file for all other drugs dispensed (non-controlled and those in schedules III, IV and V).
Products on FLORIDA Negative Formulary:
1. Digi*toxin* (Crystodigin--still on formulary, not available anymore tho) 2. Conjugated Estrogen (Premarin) 3. Dicumarol[Acadyl/Acavyl, Antitrombosin, Baracoumin, BHC(Bis-Hydroxycoumarin), Cuma/Dicoumal/ Dicoumarin/ Dicoumarol/Dufalone/Kumoran; Melitoxin/Temparin/Trombosan] 4. Chlorpromazine (solid oral dosage formulation)(Thorazine) 5. Theophylline (controlled release formulation)(Theo24 CR) 6. Pancrelipase (oral dosage formulation)(CREON, Palcaps, Pancreaze, Pancrelipase, Pangestyme EC, Panocaps, Pertzye, Ultracaps.) The generic name of a drug shall be applicable to and include all brand-name equivalents of such drug for which a prescriber may write a prescription(except when dosage form is specified--or CR/IR etc) {left out really similar brand sames}
Notable exclusions from PPPA(poison prevention packaging act)
1. Estrogen-containing products in manufacturer's dispenser package 2. Sublingual nitroglycerin 3. Effervescent formulations of aspirin/acetaminophen 4. Prednisone packages (not containing more than 105 mg) 5. Sublingual/Chewable isosorbide dinitrate 6. Powder formulations of aspirin/acetaminophen
Exemptions from requirement of child-resistant containers:
1. Patient request (can be blanket request) 2. Physician request 3. Bulk containers, not intended for household use 4. Drugs distributed to institutionalized patients 5. Package size of OTC drug designed for elderly (eg Tylenol(used for RA and important cause need to twist off caps))
For individuals under age 18 who are unable to produce a document from the list above, the following documents are acceptable to establish identity:
1. School record or report card; 2. Clinic doctor or hospital record; 3. Daycare or nursery school record. NOTE: The list of acceptable forms of identification, as cited in the CMEA, may change ("in effect on or after the date of enactment''). DEA has no discretion to alter the list.
lyrica class
5 Lacosamide also (vimpat)
NDCS
10 digits Ex: 4-4-2-5-3-2-5-4-1 first 4-5:labeler code next 3-4: drug, strength, dosage form last 1-2: size package
Central Recordkeeping Prescription Records paper Rx
2 options for filing paper prescription records and one option for electronic prescription records. Paper prescriptions for schedule II controlled substances shall be maintained at the registered location in a separate prescription file. Prescriptions for schedules III, IV, and V controlled substances shall be maintained at the registered location either in a separate prescription file for schedules III, IV, and V, or in such form that they are readily retrievable from the other prescription records of the pharmacy. Controlled substance prescriptions must be filed in one of the following ways: *Option 1:* 1. A file for schedule II controlled substances dispensed. 2. A file for schedules III, IV and V controlled substances dispensed. *Option 2:* 1. A file for all schedule II controlled substances dispensed. 2. A file for all other drugs dispensed (non-controlled and those in schedules III, IV and V). If this method is used, a prescription for a schedule III, IV or V drug must be made readily retrievable by use of a red "C" stamp not less than one inch high. If a pharmacy has an electronic recordkeeping system for prescriptions which permits identification by prescription number and retrieval of original documents by prescriber's name, patient's name, drug dispensed, and date filled, the requirement to mark the hard copy with a red "C" is waived.
Schedule V COMBINATION cough preparations with amount codeine examples
200mg of codeine per 100mL or LESS (or 100*gm*) (Robitussin AC, Phenergan w/Codeine, etc
To dispense controlled substances, requirements for a valid prescription
A prescription for a controlled substance must be *dated and signed on the date when issued*. The prescription must include: *the patient's full name and address, and the practitioner's full name, address, and DEA registration number.* the prescription must also include: 1. Drug name 2. Drug strength 3. Dosage form 4. Quantity prescribed 5. Directions for use 6. Number of refills authorized (if any) A paper prescription must be written in ink or indelible pencil or typewritten, or printed on a computer printer, and must be manually signed by the practitioner on the date when issued. An individual (i.e., secretary or nurse) may prepare prescriptions for the practitioner's signature. . The practitioner is responsible for ensuring the prescription conforms to all requirements of the law and regulations, both federal and state
What is a Rx vs what it is not
A prescription is an order for medication which is dispensed to or for an ultimate user. A prescription is *not* an order for medication which is dispensed for immediate administration to the ultimate user (i.e., an order to dispense a drug to an inpatient for immediate administration in a hospital is not a prescription). 21 CFR 1300.01(b) ("prescription").
Non-Rx meds/preparations that require child resistant containers
Advil APAP ASA Benadryl Controlled substances Dibucaine Fe containing drugs Fe containing supplements Fluoride Imidazolines Ketoprofen Lidocaine Loperamide Methyl Salicylate Methyl-alcohol (methanol) Minoxidil Naproxen
Orange book
Approved Drug Products with Therapeutic Equivalence Evaluations generic equivalency of drugs 2 letter coding system A= equivalent B=Not equivalent
fiorocet
Butalbital / Acetaminophen / Caffeine NOT CONTROLLED
Adopted as a result of public concern about thalidomide causing phocomelia
C. Kefauver-Harris Amendment of 1962
Schedule III Codeine amounts
COMBINATION products containing 90mg of Codeine per dosage unit or LESS (Tylenol w/Codeine #3, Tylenol w/Codeine #4, Fioricet w/Codeine, Fiorinal w/Codeine, etc) COMBINATION preparations containing 1,800mg of Codeine per 100mL or LESS
Institutional Pharmacy Permit types
Class I: Institutional Class II -Modified Class IIA -Modified Class IIB -Modified Class IIC Class III
Schedule II amount codeine
Codeine Sulfate tablets Any combination product containing MORE than 90mg of Codeine per dosage unit *hydrocodone/acetaminophen, hydromorphone, methadone* Any combination preparation containing *MORE* than 1,800mg of Codeine per 100mL
Authorized verbal prescriptions and refills
Durham-Humphrey Amendment
Established two classes of medications
Durham-Humphrey Amendment
Medications demonstrating inequivalence Determined by Board of Pharmacy and Board of Medicine
Florida Negative Formulary
the requirement to mark the hard copy with a red "C" is waived.
If a pharmacy has an electronic recordkeeping system for prescriptions which permits identification by prescription number and retrieval of original documents by prescriber's name, patient's name, drug dispensed, and date filled, the requirement to mark the hard copy with a red "C" is waived.
Added more extensive controls for clinical investigations by requiring the informed consent of research subjects and reporting of adverse drug reactions
Kefauver-Harris Amendment of 1962
Also referred to as the "Drug Efficacy Amendment"Requires all new drugs marketed had to be EFFECTIVE
Kefauver-Harris Amendment of 1962
Established the Good Manufacturing Practices (GMP) requirements
Kefauver-Harris Amendment of 1962
Transferred jurisdiction of prescription drug advertising from the Federal Trade Commission (FTC) to the FDA
Kefauver-Harris Amendment of 1962
Purple book
List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations Biosimilars
DEA Form 363
Narcotic Treatment Program
DEA Form 222
New schedule II order forms
Combat Methamphetamine Epidemic Act of 2005 Regulates that a seller may not sell to a single purchaser:
OTC more than 3.6 gm of ephedrine/PSE/PPA base per day OTC More than 9 gm within a 30-day period Mail order more than 7.5 gm within a 30-day period All retail sellers must self-certify annually they are following sale quantity restrictions, maintaining records, appropriately training staff and appropriately storing products
Combat Methamphetamine Epidemic Act of 2005(storage, sale per day/month/mail/rec)
Products must be stored behind the counter or in a locked cabinet if kept in an area where the public has access Regulates that a seller may *not* sell to a single purchaser: OTC more than 3.6 gm of ephedrine/PSE/PPA base per day OTC More than 9 gm within a 30-day period Mail order more than 7.5 gm within a 30-day period All retail sellers must self-certify *annually* they are following sale quantity restrictions, maintaining records, appropriately training staff and appropriately storing products
DEA Form 41
Registrant Record of Controlled Substances Destroyed
DEA Form 224a
Renewal of Pharmacy Registration 224b:Affidavit for Renewal of Retail Chain Pharmacy Registration
DEA number
Step1: 1+3+5 Step 2: (2+4+6)x2 Step1+step 2= xyz z should equal 7th digit of dea#
Proof of Identity Requirements
The CMEA requires an individual to present an *unexpired identification *card that includes a photograph and is issued by a state or the Federal Government or a document considered acceptable under 8 CFR 274a.2(b)(1)(v)(A) and (B). Those documents currently include the following: 1. United States passport; 2. Alien Registration Receipt Card or Permanent Resident Card, Form I-551; 3. A foreign passport that contains a temporary I-551 stamp, or temporary I-551 printed notation on a machine-readable immigrant visa; 4. An Employment Authorization Document which contains a photograph (Form I-766); 5. In the case of an individual who is employment-authorized incident to status or parole with a specific employer, a foreign passport with an Arrival/Departure Record, Form I-94 (as defined in 8 CFR 1.4), or Form I-94A, bearing the same name as the passport and containing an endorsement by DHS indicating such employment-authorized status or parole, as long as the period of endorsement has not yet expired and the employment is not in conflict with the individual's employment-authorized status or parole; 6. A passport from the Federated States of Micronesia (FSM) or the Republic of the Marshall Islands (RMI) with Form I-94 or Form I-94A indicating non-immigrant admission under the Compact of Free Association Between the United States and the FSM or RMI; 7. In the case of an individual lawfully enlisted for military service in the Armed Forces under 10 U.S.C. 504, a military identification card issued to such individual may be accepted only by the Armed Forces.
DEA Form 223
The Certificate of Registration
Required Information for Prescription Labels
The pharmacist dispensing a prescription for a controlled substance listed in schedules II, III, IV, or V must affix to the package a label showing date of filling, the pharmacy name and address, the serial (prescription) number, the name of the patient, the name of the prescribing practitioner, and directions for use and cautionary statements, if any, contained in such prescription as required by law. In addition to this information, if a prescription is filled at a central fill pharmacy, *the central fill *pharmacy must affix to the package a label showing* the retail pharmacy name and address and a unique identifier* (i.e., the central fill pharmacy's DEA registration number) indicating that the prescription was filled at the central fill pharmacy. . Federal Food and Drug Administration (FDA) regulations found in 21 CFR 290.5 require that the label of any drug listed as a "controlled substance" in schedules II, III, or IV of the CSA must, when dispensed to or for a patient, contain the following warning: "*CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed." for controls* In addition, a pharmacist who receives a prescription for a controlled substance must dispense that prescription to the patient or a member of the patient's household.
DEA Form 106 (
Theft or Loss of Controlled Substances) or the DEA Form 107 (Theft or Loss of Listed Chemicals)
Kefauver-Harris Amendment of 1962
This amendment, also called the Drug Efficacy Amendment, strengthened the new drug approval process by requiring that drugs be proved not only safe, but also effective. The efficacy requirement was made retroactive to all drugs marketed between 1938 and 1962.
the DEA Form 224
To register as a new pharmacy, Every pharmacy that dispenses a controlled substance must be registered with DEA [dont need to if dont carry controlls]
Scheduling of Controlled Substances: Schedule IICurrently accepted medical use:
Yes w/ restrictions
All medications are administered from individual prescription containers to individual patients
class 1
Facility may Class III permit alone, or in conjunction with other permit (this means TMH can(and does) also have class 2. Class 3 allow TMH to have nonhospital locations that are allowed to make/repackage drugs and sent to other TMH locations. More for large facilities that may have multiple sites Example: Tallahassee Memorial Hospital
class 3
Example: Westminster Oaks Nursing Home
class1
Employ registered pharmacists that provide dispensing and consulting services on the premises to patients of the facility
class2
Example: Capital Regional Medical Center, Tallahassee Memorial Hospital, Select Specialty Hospital
class2
Schedule I Potential for abuse: Potential for physical dependence Potential for psychological dependence
high high high
Expanded formulary Medications may be stored in bulk or patient-specific form Example: TMH Urgent Care Center, Red Hills Surgical Center, Florida Department of Corrections Prison
modified class 2b
Expanded formulary Medications may only be stored in patient-specific form Example: Leon County Jail
modified class 2c
Controlled Substance Theft or Significant Loss
procedures must be implemented *within one business day of the discovery *of the theft or loss. A. Notify DEA and Local Police The theft of controlled substances from a registrant is a criminal act and a source of diversion that requires notification to DEA. A pharmacy must notify *in writing* the local DEA Diversion Field Office (Appendix K) within one business day of discovery of a theft or significant loss of a controlled substance. Although *not specifically required by federal law* or regulations, the registrant should also notify *local law enforcement and state regulatory agencies.* If there is a question as to whether a theft has occurred or a loss is significant, a registrant should err on the side of caution and report it to DEA and local law enforcement authorities. *DEA must be notified directly.*This requirement is not satisfied by reporting the theft or significant loss in any other manner. For example, a corporation which owns or operates multiple registered sites and wishes to channel all notifications through corporate management or any other internal department responsible for security must still provide notice directly to their local DEA Diversion Field Office in writing within one business day upon discovery and keep a copy of that notice for its records
A corresponding liability
rests upon the pharmacist, including a pharmacist employed by a central fill pharmacy, who fills a prescription not prepared in the form prescribed by DEA regulations.
Fiorinal was a
schedule III controlled Butalbital, Aspirin, and Caffeine Capsules