Federal Pharmacy Law Questions
What is the *HIPAA Privacy Rule*?
- Limits the use and disclosure of protected health information to the "minimum necessary". - Provides an option for the patient to obtain a copy of their health record and request corrections.
What is the *Kefauver Harris Amendment* (1962)?
- Manufacturers must provide substantial evidence of safety and efficacy
What are the exceptions to the child-resistant packaging requirements?
- Nitroglycerin Sublingual Tablets - Steroid Dose Packs - Aerosols - Birth Control Pills - Female Hormone Replacement Drugs
What is the *Federal Anti-Tempering Act* (1982)?
- OTC drug products must have a tamper-evident seal
What are the Methadone Dispensing Restrictions?
- Only *registered narcotic treatment facilities* can dispense Schedule II controlled substances (Methadone) for the treatment of opioid addiction. - Facilities must complete a *DEA Form 363* to apply for DEA registration.
What are the pharmacy record-keeping requirements for Pseudoephedrine?
- Product name and quantity sold - Name, address, and signature of purchaser - Date and time of sale
What is the *Poison Prevention Packaging Act of 1970 (PPPA)*?
- Requires most medications to be dispensed in child-resistant packages - Containers must be *significantly difficult* for children under 5 years old to open, but not difficult for adults.
What is the *Omnibus Budget Reconciliation Act of 1990 (OBRA '90)*?
- Requires pharmacists to perform prospective drug utilization reviews (DURs) and offer counseling to Medicaid patients. - Pharmacists must make a reasonable effort to keep patient profiles up-to-date.
What is the *HIPAA Security Rule*?
- Requires various administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and overall security of PHI including EMR. - Outlines national standards for healthcare providers, insurance companies, and healthcare financial claim processing companies to protect the privacy of PHI.
What is the *Food and Drug Administration Modernization Act (FDAMA)* of 1997?
- The statement required to appear on legend drug labels could be shortened to "Rx only"
What is a *Class II Recall*?
- Use of or exposure to the recalled product *may cause* temporary and medically reversible adverse health effects.
What is a *Class I Recall*?
- Use of or exposure to the recalled product *will cause* serious adverse health effects up to and including death.
What is a *Class III Recall*?
- Use of the recalled product is *unlikely* to cause adverse health effects.
What is the Medicaid Tamper-Resistant Prescription requirement?
- Written outpatient prescriptions billed to Medicaid must be written on tamper-resistant paper to reduce the incidence of Medicaid fraud.
How do you verify the numerical portion of a DEA number?
1) Add the 1st, 3rd, and 5th digits. 2) Add the 2nd, 4th, and 6th digits - multiple the sum by 2. 3) Add the answers from step 1 and step 2. 4) The sum obtained in step 3 will be a 2-digit number. the second digit will match the 7th digit of the DEA number.
What must the paper contain for prescription paper to fulfill the tamper-resistant requirement?
1) At least 1 feature to prevent unauthorized copying 2) At least 1 feature to prevent erasure or modification of information written by the prescriber (checkboxes for quantities) 3) At least 1 feature to prevent the use of counterfeit prescription forms (serial numbers or logos printed on the prescription paper)
What kinds of prescriptions does the Medicaid tamper-resistant paper requirement NOT apply to?
1) Phone prescriptions 2) Fax prescriptions 3) E-prescriptions
Controlled Substance Initial Inventory
An initial inventory must be taken when a pharmacy first opens for business.
What is the official title for the Federal Orange Book?
Approved Drug Products with Therapeutic Equivalence Evaluations
How long must controlled substance records be kept?
At least *2 years*
How long must pharmacies keep all controlled substance records (including the executed DEA forms)?
At least *2 years*
How long must pharmacy records of Pseudoephedrine be maintained?
At least *2 years*
Controlled Substance Biennial Inventory
Entire controlled substance inventory must be counted at least once *every 2 years*
What is the 1st letter of the DEA number for?
Functions to identify the type of practitioner/registrant: - A, B, or F for physicians, dentists, veterinarians, hospitals, and pharmacies. - M for midlevel practitioners. - P or R for manufacturers, distributors, researchers, and narcotic treatment programs.
What is the *Combat Methamphetamine Epidemic Act of 2005 (CMEA)*?
Law imposes regulations on the OTC sale of solid dosage forms (including gel caps) that contain: - Pseudoephedrine (--> Methamphetamine) - Ephedrine (--> Methamphetamine) - Phenylpropanolamine (--> Amphetamine)
What is the 2nd letter of the DEA number for?
Matches the first letter of the prescriber's last name or the first letter of the business name.
What does *misbranded* mean?
Problem(s) with the *labeling*, such as: - False information - Misleading information - Insufficient information
What does *adulterated* mean?
Problem(s) with the *product*, such as the: - Strength of the product - Quality of the product - Purity of the product
Newly Scheduled Drug or Change in Schedule of a Drug
When a drug is newly scheduled as a controlled substance or the scheduling of a drug is changed, an inventory is required for the affected drug on the day that the scheduling or change in scheduling takes effect.
What are the different copies of DEA Form 222?
- First page (the original) - *brown* - must be retained by the drug supplier - Second page (first carbon copy) - *green* - must be forwarded to the DEA by the drug supplier - Third page (second carbon copy) - *blue* - must be retained by the pharmacy
What is the purpose of DEA Form 224?
- For applying for a DEA registration number
What is the purpose of DEA Form 222?
- For ordering Schedule I and II controlled substances
What is the purpose of DEA Form 222a?
- For ordering an additional supply of DEA 222 forms
What is the purpose of DEA Form 224a?
- For renewing DEA registration (renewal is required every 3 years)
What is the purpose of DEA Form 104?
- For reporting a pharmacy closure of surrender of a pharmacy permit
What is the purpose of DEA Form 41?
- For reporting the destruction of controlled substances
What is the purpose of DEA Form 106?
- For reporting the loss or theft of controlled substances
When ordering Schedule II controlled substances for your pharmacy, what must you do with the first two pages (brown and green) of the DEA Form 222?
- Give them to the supplier without separating them - For the form to be valid from the supplier's perspective, the brown and green copies must be intact with the carbon paper between them. - The pharmacy must retain the third page (blue copy) of the form for record-keeping purposes.
How often must a DEA registration be renewed?
*Every 3 years*
What is the difference between compounding and manufacturing in terms of where each must take place?
- *Compounding* must take place in a *registered pharmacy* under the supervision of a licensed pharmacist. - *Manufacturing* must take place in a *registered drug manufacturing facility*.
What information is required to appear on an OTC drug package label?
- *Drug Facts* - Active ingredient(s) and strength or concentration per dosage unit - Purpose(s) - *Use(s)* - *Warning(s)* - *Directions* - Specific instructions based on age, recommended dose, frequency of dosing and maximum daily dose - *Other Information* - Storage requirements - *Inactive Ingredients* - List of ingredients that do not affect therapeutic action, such as flavoring agents, colorants, and preservatives - *Contact Information* - Name, location, and phone number of the manufacturer
What are the limitations of compounding?
- A compounded drug product *cannot be a copy* of a commercially available FDA-approved product. - A compounded drug product cannot contain any ingredient that has been deemed unsafe or ineffective. - A product can *only* be compounded *after* receiving an individual, patient-specific prescription order *or* in anticipation of receiving a patient-specific prescription order *if* an established prescribing pattern exists.
Inventory Counting Procedure for C-III, C-IV, C-V Controlled Substances
- An *estimate* or exact count is acceptable for opened containers that hold *< 1,000 tablets or capsules*. - An *exact count* is required for opened containers that hold *> 1,000 tablets or capsules*.
Inventory Counting Procedure for C-II Controlled Substances
- An *exact count* or measure of every container is required regardless of size
What is the *Prescription Drug Marketing Act (PDMA)* of 1987?
- Banned the selling/purchasing/trading of prescription drug samples
What is the *Drug Quality and Security Act of 2013*?
- Certain large-scale compounding facilities must register with the FDA as *outsourcing facilities* and comply with current GMP (CGMP).
What is the definition of *Compounding*?
- Compounding is the creation of personalized, patient-specific medications.
What are the OTC purchase limits of Pseudoephedrine?
- Daily limit = 3.6 grams/day per customer - Monthly limit = 9 grams/month per customer - A maximum of 7.5 grams of the monthly 9-gram limit can be obtained by mail
What is the *Dietary Supplement Health and Education Act (DSHEA)* of 1994?
- Dietary supplements are classified as "food" since they supplement the diet --> manufacturers can market dietary supplements without FDA review - For drug products, a manufacturer must prove safety before entering the market, but for food products the FDA must prove lack of safety to be able to take product off the market.
When does the "Minimum Necessary Use and Disclosure" not apply?
- Disclosures to a healthcare provider for treatment - Disclosures to the patient upon request - Disclosures authorized by the patient - Disclosures necessary to comply with other laws - Disclosures to the Department of Health and Human Services (HHS) for a compliance investigation, review, or enforcement
What are the restrictions for dispensing Methadone from a pharmacy?
- Dispensing methadone for the treatment of *pain* is *permitted*. - Dispensing methadone for the treatment of *addiction* is *prohibited*.
What is the *Durham-Humphrey Amendment* (1951)?
- Drug products are separated into 2 categories (OTC and legend drugs). - Legend drug labels must state "Caution: Federal law prohibits dispensing without a prescription"
What is the *HIPAA Breach Notification Rule*?
- If PHI has been exposed to unauthorized individuals, the affected patient(s) must be notified.
