RX PHARMACIST STUDY NOTES

Question 1

What are some tasks of the FDA?

Answer 1

1- Licensing and inspecting manufacturing facilities to ensure they follow GMP
2- Tests products on a smaller scale to evaluate claims and prescription drug advertising
3- Monitors research
4- Reviews clinical trial methods
5- Creates regulations, guidelines, standards, policies

Question 2

What is the main center in the FDA which reviews prescription drugs?

Answer 2

CDER (Center for Drug Evaluation and Research)

Question 3

Who regulates the advertising of OTC, medical devices and cosmetics?

Answer 3

Federal Trade Commission (FTC)

Question 4

What is the role of the United States Pharmacopoeia (USP)?

Answer 4

Regulation of OTC, natural supplements, dietary products

USP 800, 795, 797

Question 5

What is considered a ‘New Drug’?

Answer 5

-One that is not already recognized as safe and effective for the indications stated by the manufacturer.
-A drug that is already in existence, although never approved by the FDA for marketing in the USA.
-New therapeutic indications
-New dosage form
-New route of administration
-New dosing schedule or any other significant clinical difference

Question 6

How are OTC medications approved?

Answer 6

OTC medications are only regulated by FDA through the OTC drug monographs.

OTC drug monograph are kind of “ recipe book” covering acceptable ingredients, doses, formulations, and labeling. Monographs are continually updated, adding additional ingredients and labeling as needed. Products conforming to a monograph may be marketed without further FDA clearance.

Otherwise, those that do not conform to the monograph must undergo a separate review and approval through the “New Drug Approval System”.

Question 7

Investigational New Drug Application (IND)

Answer 7

After the pre-clinical stage (1-2 years), if a drug is proven to be safe and have a therapeutic effect, then the manufacturer may apply for a IND.

The IND must contain information on the characteristics of the proposed drug and the details of its study. sponsors take responsibility for a clinical investigation.

A sponsor can be an individual, pharmaceutical company, governmental agency, academic institution, private, or other organizations such as a nonprofit.

An investigator is the individual who conduct the investigation.

Sponsor-investigator is an individual with a dual role of investigating and overseeing the direction of the investigational drug being administered or dispensed.

Question 8

Prescription Drug User Fee Act (PDUFA)

Answer 8

-PDUFA allows the FDA to collect fees from sponsor companies who submit review applications.

-This was a result of the Prescription Drug User Fee Act (PDUFA) and the FDA Modernization Act (FDAMA)
-PDUFA must be re-authorized every 5 years
-This act also requires the FDA to speed up the approval timeframe, which is an expectation by the pharmaceutical industry given the increased fees for filing an NDA. Approval rates have increased from 50% to 80%
-It waives the fees for first-time applicants who have <500 employees.

Question 9

Orphan Drug approval

Answer 9

-An orphan drug is defined under the orphan drug act of 1983. It is a drug used to treat a rare disease that would not normally be of interest to commercial manufacturers. Rare disease is defined in the law as a disease that impacts fewer than 200,000 persons in the United States, or one in which a manufacturer has no reasonable expectation of recovering the cost of its development and availability in the United States.

The Act permits:
1) Grants of assistance for clinical research
2) Tax credits for research and development
3) 7 year market exclusivity to the first applicant. This means that if a sponsor gains approval for an orphan drug, the FDA will not approve any application by any other sponsor for the same drug and the same disease or condition for seven years.

Question 10

What is an Abbreviated New Drug Application (ANDA)?

Answer 10

-ANDA are used when a patent has expired for a product that has been on the US market, and a company wishes the market a generic version.
-In the United States, a drug patent is valid for 20 years.
-The active ingredient must already have been approved for the indications proposed in the ANDA.
-There can be no changes on the original drug’s NDA.

Question 11

What is the Orange Book?

Answer 11

Also known as: Approved Drug Products with Therapeutic Equivalence Evaluations

This is a list of all approved drugs. It provides information on therapeutic equivalence evaluations for approved multi-source prescription drugs.

Question 12

What is meant by Therapeutic Equivalence?

Answer 12

It must be both PHARMACEUTICALLY EQUIVALENT (same dose, dosage form, strength) and BIOEQUIVALENT (the rate and extent of absorption are not significantly different)

Question 13

What is the Coding System used in the Orange Book?

Answer 13

1) First letter (either A or B) - indicates the drug’s therapeutic equivalence rating.
2) Second letter (several letters) - describes dosage form

First letter:

A - Therapeutically equivalent to other pharmaceutically equivalent products. There is no known or suspected bioequivalence problems

B - Less desirable rating than A. These may still be marketed commercially, but they may not be considered therapeutically equivalent. Often the problem is with the dosage form and not with the active ingredient.
B* - This is assigned to former A-rated drugs if the FDA received new information that raises a significant question regarding therapeutic equivalence.

Question 14

What happens if there a report of an adverse event in a drug’s Phase 4?

Answer 14

-Must be reviewed by the manufacturer promptly
-If found to be serious or life threatening or unexpected, the manufacturer is required to submit an alert report within 15 business days.
-Other reports are required to be reported quarterly for 3 years after approval of the application, and annually thereafter.

Question 15

What are the criteria to make a drug “prescription”?

Answer 15

According to the Durham-Humphrey Amendment of 1951:
1) The compound is habit forming
2) The compound requires a prescriber’s supervision
3) The compound has an NDA prescription-only limitation

OTC products do not fall under prescription status if their active ingredients are deemed “generally recognized as safe and effective”

Question 16

How does a product move from “Prescription” Status to “OTC” Status?

Answer 16

A company who wishes to make this switch can submit an amendment to a monograph to the FDA, who acts as the sole reviewer, or

They may also file an sNDA provided that the product:
1) Had 3 years of marketing experience as a prescription product
2) Relatively high use during that period
3) Mild profile of adverse reactions.

Question 17

What is the OTC Monograph Reform?

Answer 17

Signed in 2020 under the Coronavirus Aid, Relief, and Economics Security Act (CARES)

• This regulation replaced the 3-phase rule-making process with the Administrative Order Process (This allows for additions, removals or changes to an OTC Monograph)
• This process can be initiated by the FDA or Industry

The law permits the FDA to use an expedited procedure to address drugs that pose imminent safety concerns in a timely manner as well as collect user fees to support OTC monograph activities.

Question 18

Which regulation governs Prescription Drug Advertising?

Answer 18

1962 Kefauver-Harris Amendment

The FDA has jurisdiction over prescription drug advertising and promotion. The FDA views this information as either “advertising” or “labeling”

Advertising - includes all traditional outlets in which a company places an ad.
Labeling - includes everything else, including brochures, lectures, slide kits, letters to physicians, company-sponsored magazine articles etc.

Basically, all material facts must be disclosed in a manner that is fairly accurate and not misleading. A violation of this is considered “misbranding”.

Question 19

Drug Samples

Answer 19

1987 Prescription Drug Marketing Act (PDMA)

• Company reps are prohibited from directly distributing or reselling prescription drug samples.
• Companies are required to establish a closed system of record keeping that can track a sample from their control to that of a prescriber in order to prevent diversion.
• Prescribers are required to receive, record and store them appropriately

Question 20

Enforcement by the FDA

Answer 20

1938 Food Drug and Cosmetic Act, the FDA has the power to
- Enforce regulations
- Inspect a manufacturer’s premises and records
-

Question 21

What happens after a facility is inspected by the FDA?

Answer 21

• An FDA Form 483 is issued which describes observable violations
• A Warning Letter may be issued if one or more of a company’s practices, products or procedures violate the FDCA. 15 days to respond
  -The FDA has no authority to force a company to recall, but it has the authority to force the removal of a product through a seizure.

Question 22

Types of Recalls

Answer 22

Based on Adverse Effects of the drug product

Class 1: “a product WILL CAUSE either serious adverse effects or death”

Class 2: “a product MAY CAUSE TEMPORARY or MEDICALLY REVERSIBLE adverse effects”

Class 3: “a product is NOT LIKELY to cause adverse health consequences”

Question 23

What happens if a company refuses to recall a product?

Answer 23

1) Injunction
- The FDA will seek an injunction against the company
- An injunction is recommended to the DOJ by the FDA
- The DOJ takes the request to federal court, which issues an order that forbids a company from carrying out an illegal act, such as marketing a product that the FDA considers a violation of the FDCA

2) Seizure by US Marshals, ordered by the Federal Court
- FDA may also initiate a seizure of violative, misbranded or adulterated products
- It prevents a company from selling, distributing, moving or otherwise tampering with the product.

Question 24

When was the Controlled Substances Act enacted?

Answer 24

1970

It regulates the manufacturing, distribution, dispensing and delivery of drugs with potential for abuse.

Regulated by the DEA
-The DEA requires federal registration of all individuals involved in the chain of manufacturing, distribution and dispensing.

Question 25

How long should Controlled Substances records be maintained for?

Answer 25

2 years per the DEA manual

Question 26

What are the C-1 Controlled Substances?

Answer 26

-Drugs with high potential for abuse
-No acceptable medical use in the US
-They may be ordered for research and investigational use

Examples:
-Marijuana
-Heroin
-LSD
-Peyote
-Salvia

Question 27

What are the C-2 Controlled Substances?

Answer 27

-High potential for abuse
-Acceptable medical use
-No refills are allowed, however prescribers can write a series of prescriptions for a patient for up to a 90-day supply. Pharmacists can fill these as long as it is a valid prescription with the actual date that the prescription was written and the earliest date to fill is noted on the prescription.

Question 28

Can a verbal/oral prescription be taken for C-2s?

Answer 28

-Only in emergencies

-The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period.
-The written prescription must arrive at the pharmacy within 7 days and the pharmacist should write on the face of the prescription “Authorization for Emergency Dispensing”
-Upon receipt, the dispensing pharmacist must attach the prescription to the oral one.
-If the prescribing practitioner fails to deliver a written prescription within 7 days, the pharmacist needs to notify the DEA and the prescribing practitioner will face criminal charges.

Question 29

What is ‘Corresponding Responsibility”?

Answer 29

Pharmacists and Prescribers are both liable for prescriptions written in error or with obvious problems.

Question 30

Can C-2 prescriptions be faxed?

Answer 30

No

Exceptions:
1) Home infusion/IV parenteral therapy if for pain
2) LTC Residents
3) Registered hospice facility

Question 31

Are partial fills permissible for C-2’s?

Answer 31

-YES, only if the pharmacist does not have a sufficient quantity to fill the entire prescription.
-The pharmacist must note on the prescription the amount that was dispensed in the partial filling.
-72 hours to fill the remaining quantity
-If the prescription is not completed within 72 hours, then the remaining amount is void.

LTC Facility:
-Partials are allowed, and prescription is valid for 60 days from date written.
-Pharmacist must note the date filled, quantity dispensed and remainder along with a signature.

Question 32

How to Order C-2’s?

Answer 32

• DEA Form 222 or CSOS (Controlled Substances Ordering System)

DEA Form 222: Handwritten, C-2’s only
CSOS: Digital, all drugs

*Any markings or misspelling makes the form VOID

Question 33

What are C-3 and C-4 Controlled Substances?

Answer 33

-These drugs have a potential for abuse but risk is not as high as C-2’s
-MAX of 5 refills in 6 months from the date the prescription was written
-Partials are allowed if the max 5 fills in 6 months is not breached.
-One transfer is allowed. If shared database, multiple transfers are possible
-DEA Form 222 or CSOS is not required

Example of Schedule 3: Buprenorphine, Anabolic Steroids, Tylenol #3 (with Codeine)
Example of Schedule 4: Benzodiazepines, Lunesta, Tramadol, Zuranolone

Question 34

What are the C-5 Controlled Substances?

Answer 34

-Lowest risk for abuse
-No limit for refills
-One transfer is allowed. If shared database, multiple transfers are possible.
-Partials are allowed. Cannot fill past 6 months

Example of C-5: Lyrica (requires Rx), Lomotil, Phenergan with Codeine, Robitussin AC

-Most C-5 drugs do not need a prescription as along as it contains LESS THAN 200 mg Codeine or per 100 mL.
-Pharmacist must dispense this
- At least 18 years y.o.
The following must be recorded in a logbook:
1) Name and Address of buyer
2) Name, date and quantity purchased
3) Name of the pharmacist that dispensed the product

Question 35

What is the 5% Rule?

Answer 35

The rule states that in one year, a DEA registrant cannot transfer more than 5% of the total number of controlled substances dispensed.

This is done to prevent drug diversion between registrants.

Question 36

Transfer of Electronic Prescriptions for C2-5 Controlled Substances for initial dispensing

Answer 36

Electronic Prescriptions for C2-5 can be transferred between retail pharmacies for an initial filling one time upon request.

The prescription must remain in e-format.

The transfer of Electronic Prescriptions for Controlled Substances (EPCS) for initial dispensing is permissible ONLY if allowed in the State.

Question 37

DEA Registration

Answer 37

• All practitioners involved in the chain must have a DEA registration number.
• Federally-employed practitioners are not required to have one.
• DEA registration number for a PRACTITIONER begins with A or B
• DEA registration number for a MID-LEVEL PRACTITIONER begins with M
• The second letter of the DEA reg. Number is the first letter of the last name.

Question 38

How to check if a DEA number is valid?

Answer 38

MT3614511

1- Add together the odd-positioned number (3 + 1 + 5 = 9)
2- Add together the even-positioned number (6 + 4 + 1 = 11 x 2 = 22)
3- Add the numbers (9 + 22 = 31)
4- The last digit of the sum should be the last digit of the DEA number (1)

Question 39

Should pharmacies have a DEA number?

Answer 39

Yes, pharmacies need to fill out a DEA Form 224 if they buy and sell controlled substances.

-If there is a transfer of a pharmacy business to another registrant, then the DA needs to be notified at least 14 days before the transfer.

Question 40

Can a dentist prescribe Addrall?

Answer 40

An order for controlled substances that seems to be valid prescription,but is not issued in the usual course of professional treatment or for investigational research is not a valid prescription within the meaning and intent of the CSA.

If a pharmacist suspects fraudulent prescribing but still dispenses the medication, he or she is subject to criminal and possibly civil actions.

-practitioners are not allowed to obtain a supply of control substances for general dispensing. They are limited to their scope of practice. For example, dentist can only prescribe for the treatment of the oral cavity area. You shouldn’t expect a prescription for Ambien or Lyrica from them.

Question 41

Prescription for Controlled Substances

Answer 41

• Prescriptions must be written in ink, typed or printed by the prescriber or their agent.
• The only information that must be in the prescriber’s own handwriting is their signature.
• Verbal prescriptions and Fax can be taken for C3-5
• Prescription must be issued in good faith and for a legitimate medical purpose by a practitioner in the usual course of his/her professional practice.

Information needed on a prescription:
1) Date written
2) Name and Address of Patient
3) Name, Address, Signature and DEA number of Prescriber
4) Name, Strength, Dose, Quantity, Directions of Drug
5) Refills (if any)

Question 42

How can prescriptions be filed in a pharmacy?

Answer 42

1) 2 Files: C2, C3-5 & Non-controlled <—Most common
2) 2 Files: C2-5, Non-controlled
3) 3 Files: C2, C3-5, Non-controlled

Question 43

Can pharmacists fill prescriptions for Methadone?

Answer 43

• Prescriptions for methadone are valid provided that the drug is used as an analgesic
• They are NOT valid through the typical retail pharmacy distribution channels for the purposes of detoxification or maintenance therapy for drug addiction.
• Physicians are allowed to administer the drug in emergency situations to relieve acute withdrawal symptoms for the purpose of admitting the individual to a licensed treatment program. Only a single-day quantity for three consecutive days can be administered.

Question 44

Can control substances be mailed?

Answer 44

Yes (only through USPS)

Rules:
1) The inner container must be marked, sealed and labeled with the name and address of the practitioner, or the name and address of the pharmacy or other person dispensing the prescription and prescription number.
2) The container must be plain with no markings of any kind that would indicate the contents within.

Question 45

Can control substances be mailed?

Answer 45

Yes (only through USPS)

Rules:
1) The inner container must be marked, sealed and labeled with the name and address of the practitioner, or the name and address of the pharmacy or other person dispensing the prescription and prescription number.
2) The container must be plain with no markings of any kind that would indicate the contents within.

Question 46

Labeling for Controlled Substances

Answer 46

1) Pharmacy name, address and telephone number
2) Date of filling
3) Prescription number
4) Name of Prescriber
5) Name of Patient
6) Directions for use and cautionary statement
7) Controlled Substances warning label “CAUTION: federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.” [C2-C4 only]

Question 47

DEA Controlled Substances Requirements of the Pharmacy

Answer 47

All records kept for 2 years

• Register with the DEA
• Renew certificate of registration every 3 years
• Dated invoices
• DEA Form 222
• If changing address, notify and receive approval before moving.
• Records kept on premises unless request to move records is approved by the DEA. Transfer only after 14 days of notifying the DEA.

Question 48

Federal Controlled Substances Inventory Requirement

Answer 48

Biennial (every other year) inventory must be taken of all federally controlled substances (C2-C5) after the last inventory.

• Exact count on C2
• Estimate on C3-C5, unless the container holds more than 1000 units, in which case an exact count must be completed.

Question 49

DEA Forms

Answer 49

1) DEA Form 41
- Used to document the destruction of controlled substances.

2) DEA Form 106
- Used to report loss of control substances C2-5
-If a pharmacy is involved in a robbery or discovers a significant shortage of a controlled substance, it must be rreported to the DEA and local police. DEA form 106 should be filled out and sent to the DEA as soon as possible. If a pharmacist knowingly fails to eport theft within 24 hours of discovery, they could be charged and fined.

2) DEA Form 222
- Used to order C2 to stock a pharmacy, and physically transfer to another pharmacy.
- One item per line.
- Purchaser must make a copy of the original for record keeping since the original form is sent to the supplier.
- Once the purchaser receives their order, they must record the date of receipt and a number of containers received on their copy of DEA form 222.

4) DEA Form 224 - This form is used to file for a new registration for a retail pharmacy, hospital/clinic, practitioner, teaching institution, and mid-level practitioner.

Question 50

Is reconstitution of a product considered compounding according to USP 795?

Answer 50

If its for an individual patient, then NO.

If it is stored for future use, then YES, it is compounding.

Question 51

What is the BUD for “non-preserved aqueous dosage form”?

Answer 51

USP 795:

14 days refrigerated

Aqueous: emulsions, gels, creams, solutions, sprays, suspensions

Question 52

What is the BUD for “Preserved aqueous dosage form”?

Answer 52

USP 795:

35 days (CRT or Refrigerated)

Question 53

What is the BUD for “non-aqueous Oral Liquids”?

Answer 53

USP 795:

90 days (CRT or Refrigerated)

Non-aqueous: ointments, capsules, tablets, granules, powders, non-aqueous topicals, suppositories

Question 54

What is the BUD for “Other non-aqueous dosage forms”?

Answer 54

USP 795:

180 days (CRT or Refrigerated)

Question 55

What is the BUD for a Category 1 Sterile Compounded product?

Answer 55

<= 12 hours at CRT

<= 24 hours at Refrigration

Category 1: CSPs are typically compounded under the least controlled environmental conditions and may be prepared in an unclassified segregated compounding area.

Question 56

What is the BUD for a Category 2 Sterile Compounded product?

Answer 56

Category 2: CSPs require more environmental controls and testing than Category 1 and must be prepared in a cleanroom suite.

1) Aseptically processed, no sterility. Only one sterile starting components
- 4 days at CRT
- 10 days at Refrigeration
- 45 days in Freezer

2) Aseptically processed, no sterility. One or more non-sterile starting component.
- 1 day at CRT
- 4 days at Refrigeration
- 45 days in Freezer

Question 57

What is the BUD for a Category 3 Sterile Compounded product?

Answer 57

Category 3: CSPs undergo sterility testing and have more requirements than category 2 for the qualification of personnel, use of sterile garb and disinfectants, and frequency of environmental monitoring.

1) Aseptically processed, sterility tested. Passed all applicable Category 3 tests:
- 60 days at CRT
- 90 days in Refrigeration
- 120 days in Freezer

2) Terminally sterilized, sterility tested, passing all applicable Category 3 tests:
- 90 at CRT
- 120 days in Refrigeration
- 180 days in Freezer

Question 58

What is the Compounding Space requirement as per USP 795?

Answer 58

• Be well lit, clean, orderly and sanitary
• Other activities must not be occurring in the space at the same time as compounding
• Provide for the orderly placement of equipment and materials to prevent mix-ups.

Question 59

What is the Cleaning Requirement as per USP 795?

Answer 59

1) Ceilings: when visibly soiled or when contamination is known/suspected
2) Walls & Storage Shelves: q3mths and after spills
3) Floors: Daily and after spills
4) Work Surface: At the beginning and end of each shift and after spills. Clean and sanitize between compounding with different components.

Question 60

What are the required documentation for non-sterile compounding as per USP 795 & USP 797?

Answer 60

1) Master Formulation Record (Ingredients and Instructions)

2) Compounding Record
- Logbook of all products made at the pharmacy (compound’s assigned name, strength, and dosage form)
- Reference for the master formula
- Components with their source, lot numbers, and expiration dates, control or prescription number, beyond-use date, description, and
- Pharmacist who approved the preparation

Documentation must be detailed enough so that another trainer person can replicate

Must keep records of steps and processes

Question 61

Garbing Technique

Answer 61

Garbing is donned in the ante area and should be donned in order – Think about going from the dirtiest to cleanest:

1- Don dedicated shoes or shoe covers, head and facial hair covers, and face masks. 2nd pair of shoe covers are needed for compounding HDs
2- Hand hygiene with soap and warm water for 30 seconds
3- Dry hands and forearms with lint-free disposable towels
4- Don a non-shedding gown
5- Enter the buffer area
6- Apply an alcohol-based surgical hand scrub with persistent antimicrobial activity
7- Don sterile, powder-free gloves (2 pairs of chemo gloves are required for compounding HDs)
8- Sanitize the gloves with 70% IPA routinely and whenever the gloves touch non-sterile surfaces

Question 61

Who maintains a list of Hazardous Drugs?

Answer 61

NIOSH (National Institute for Occupational health and safety)

It is reviewed every 12 months.

USP 800 sets the standards on how to work safely with HDs.

Question 62

What are the categories of Hazardous Drugs?

Answer 62

1- Antineoplastics (chemo)
2- Non-antineoplastics (hormones and transplant)
3- Drugs with Reproductive Risk (All pregnancy Category X)

Question 62

Space for preparing HDs

Answer 62

-Sterile hood used for HDs –> the containment primary engineering control (C-PEC).
-The room where the C-PEC is located –> the containment secondary engineering control (C-SEC).
-Supplemental engineering controls (i.e., closed-system drug-transfer device).

1) HDs have to be prepared in a vertical laminar airflow PEC. This keeps HDs away from compounding personnel.

2)Non-HDs are prepared in a horizontal laminar airflow PEC.

Sterile and nonsterile HDs must be compounded within a C-PEC located in a C-SEC.

The C-SEC used for sterile and nonsterile compounding must:
1) Be externally vented
2) Be physically separated
3) Have an appropriate air exchange (pressure and air exchange requirements are listed in tables under the Compounding below)

Question 63

Personnel Training for handling HDs

Answer 63

-Staff training must be documented before handling hazardous drugs
- Reassessed and documented every 12 months
- Training must include:
1) Overview of entity’s list of HDs and their risks
2) Review of the entity’s SOPs related to the handling of HDs
3) Proper use of PPE, equipment n devices
4) Response to known/suspected HD exposure
5) Spill management
6) Proper disposal of HDs and trace-contaminated materials

If HD dosage forms do require manipulation such as crushing tablet(s) or opening capsule(s) for a single dose, personnel must don appropriate PPE and use a plastic pouch to contain any dust or particles generated.

Question 64

HDs Cleaning

Answer 64

-Once Daily
1) Deactivation (2% Bleach)
2) Decontamination (Water)
3) Cleaning (Germicidal Detergent)
4) Disinfection (70% IPA)

The solutions used for cleaning must be compatible with the surface(s) it is being used on. Moreover, solutions should be applied by wetting wipes rather than through a spray bottle. Often times, institutions may use kits that include each component of the cleaning steps.

Question 65

Disposal of HDs and PPE

Answer 65

Yellow Bin: PPE and empty vials

Black Bin: Bulk disposal e.g. partially empty IV bags, syringe and vials

Red Bin: Non-HD waste

All 3 bins are for HD disposal

Note: All chemotherapy preparations must have a label, “Chemotherapy – dispose of properly”

Question 66

Should package inserts be given to patients when dispensing?

Answer 66

Per FDA, YES:
- For certain drugs only
- Initial dispensing
- Refills, if requested

Question 67

Which drugs MUST be dispensed with a PPI?

Answer 67

1) Isoproterenol Inhalation products
2) Oral Contraceptives & Estrogen/progesterone containing drug products
4) Intrauterine devices
5) Accutane R
6) Pre-gestational Drugs

Question 68

What are Schedule Listed Chemical Products (SLCP)?

Answer 68

These are products used in the production of methamphetamines. This applies to nonprescription drugs only, not prescription drug products.

Created by the Combat Methamphetamine Epidemic Act (CMEA) of 2005

List 1 Chemicals: Drugs involved in the manufacturing of a controlled substance. Examples are Ephedrine, Pseudoephedrine, Ergonovine, Iodine, Safrole, Piperidine.

List 2 Chemicals: Solvents used in the manufacturing of a controlled substance. Examples are Acetone, HCl, K/Na-Permanganate.

Question 69

CMEA Requirements

Answer 69

CMEA - Combat Methamphetamine Epidemic Act 2005

-Place products behind the counter or in locked cabinets
-Check identity of purchasers and maintain a log of each sale that includes name and address, signature of purchaser, product sold, quantity sold, date and time.
-Maintain records for 2 years
-Train employees in the requirements of the law and certify to the DEA that the training has occurred.

Question 70

Regulation of Pseudoephedrine

Answer 70

MAX: 3.6 grams/day of the chemical base or 9 grams/month of pseudoephedrine may be sold to individuals with a valid ID.

No more than 7.5 grams/30-day may be imported by means of contract carrier or USPS.

Question 71

Poison Prevention Packaging Exemptions

Answer 71

1970 Poison Prevention Packaging Act

-Aspirin or Acetaminophen effervescent tabs or granules
-Nitroglycerin
-Isosorbide dinitrate
-Erythromycin
-Mebendazole

-Anhydrous Cholestyramine
-Colestipol
-Sucrase
-Pancrelipase
-Potassium Supplements
-Sodium Fluoride

-Betamethasone
-Methylprednisolone
-Prednisone
-Oral Contraceptives
-Conjugated estrogen
-Norethindrone acetate
- Hormone Replacement Therapy

Question 72

Specific Labeling Requirement

Answer 72