Federal Regulation of Medications - Dispensing Flashcards
What does the Durham-Humphrey Amendment do?
Legally establishes refills and oral prescriptions. Establishes criteria for distinguishing Rx vs. OTC drugs
Does the Durham-Humphrey Amendment include electronic prescriptions?
NO
What is the legal concern with oral prescriptions from Durham-Humphrey?
Responsibility of the pharmacist to get the prescription correct
What does the Durham-Humphrey Amendment 2 do?
Specifies the MINIMUM information that a dispense prescription label must contain
What are the components that are the MINIMUM on every dispensed prescription label?
- Name/Address of DISPENSER
- Serial number and DATE of prescription filling
- Name of PRESCRIBER
- Name of PATIENT
- DIRECTIONS for use and cautionary statements
Where do number of refills and name of drug fall under for requirements on a label?
STATE laws that require ADDITIONAL information compared to Durham-Humphrey
Where does the regulation fall under for expiration or beyond use dating on dispensed Rxs?
STATE laws, guided by USP
What is a consideration for prescription refill related to Durham-Humphrey?
Authorization of refill comes from TRANSMITTAL authority
Who has prescriptive authority based on Durham-Humphrey?
Federal law leaves it up to the STATES to determine who may prescribe independently or through collaborative practice
As a pharmacist what you need to know about a prescriber?
A scope of their practice and if the medications they are prescribing makes sense
Does Durham-Humphrey dispensing standards apply to prescribers?
FDA believes NO
What are the three ways in which the transition of Prescription Drugs switch to OTC?
- Supplemental NDA
- Other Party Manufacturer
- FDA adds or amends OTC drug monograph
What is a Citizen Petition?
A product-specific switch from Rx to OTC done by another manufacturer
When the FDA adds/amend OTC drug monographs, what happens to the Rx to OTC?
It affects all products in the class
What is the Nonprescription Under Conditions of Safe Use?
Refers to creating a class of drugs that can only be sold from the pharmacy department
What is a Conscientious Objection?
Refers to whether a pharmacist has a right to refuse to dispense prescriptions when a moral or religious objection exists
Courts have held that a pharmacist CANNOT obstruct a patient’s legal right to receive medications but?
But the STATE regulations requires pharmacists to dispense violate first amendment rights
Is off-label prescribing and dispensing legal under the FDCA?
YES
What do courts require for off label use?
Evidence OF the standard the care, not the actual standard of care
Pharmacy compounding is allowed in what situations?
PATIENT SPECIFIC needs
What is the FDA 1992 Compliance Policy Guide CPG?
Published over concern that some pharmacies were crossing the line from compounding to manufacturing and compounding improperly
What is the FDAMA 503A 1997?
Canceled the CPG
Defined compounding and delineated nine conditions that might cross the line from compounding to manufacturing
What was the big act of the FDAMA 503A 1997?
Stripped FDA of authority to consider compounded drugs as new drugs
What are the NINE Conditions of the FDAMA 503A 1997?
- Individual patient by prescription
- Limited quantities ‘pre-made’ in anticipation of Rx
- Cannot copy commercially available product
- Compounded in compliance with USP standards for compounding
- Compounded with bulk ingredients manufactured by entity registered with FDA
- All ingredients comply with USP Standards
- No drugs from DFA List of withdrawn/removed agents due to safety/efficacy concerns
- No FDA regulated products with difficulty compounding
- Not more than 5% of total sales unless a memorandum of understanding MOU between state and FDA
What is the FDA 2002 Compliance Policy Guide CPG?
FDA said the Nine Conditions were not valid due to the advertising law being unconstitutional, but reinstitute most of the requirements back in the 2002 CPG
What was the key change in the FDA 2002 CPG?
Re-established FDA position that pharmacy-compounded drugs are NEW drugs
What is the Compounding Quality Act of 2013?
Part of the Drug Quality and Security Act, reinstated 503A without the unconstitutional provisions, stripped FDA of new drug authority
What was the big change of the Compounding Quality Act of 2013?
Added 503B, compounders of sterile products voluntarily register with FDA as OUTSOURCING facilities
What is the CGMP Compliance that is REQUIRED?
All compounded products regulated under 503B, cannot have separate area functioning as a 503A Pharmacy
When is Repackaging allowed based on FDACPG 2017?
Drug shortages, direct supervision of a pharmacist, patient specific dispensing
What are Copies based on the FDA CPG 2018?
Cannot compound regular or inordinate amounts of commercially available products
What is considered a copy?
Same active, route, form/strength (10%), and excipients
What is the monthly limit for copies?
4 or fewer
What are the exceptions to copies?
Patient specific modification, shortages, and discontinued products
What is the concern with hospitals in FDA CPG 2016?
503A says there is no distinction between retail or hospital pharmacy
What is the exception for hospitals for compounding without patient specific orders?
- Distribution to hospital entities within 1 mile
- Administer pursuant to prescription/order
- Product meets all 503/FDCA requirements
What is an MOU?
Memorandum of Understanding
What requires an MOU between states and FDA to allow a compounding pharmacy to distribute more than 5% of total prescriptions?
503A
Are states required to in inspect and report distribution if what?
More than 30% of all compounded drugs by the entire state are crossing state lines, interstate
What is Anticipatory Compounding?
(30 day supply) x (Highest valid Rx supply received in 30 days during past year) = max amount you can have
When did USP 800 become effective?
12/01/2019
What is USP 800 entail?
To protect healthcare worker environments and patients from exposure
What are the entities handing hazardous drugs that must be maintained in USP 800?
- List of drugs
- Proper facility and engineering controls
- Competent personnel
- Safe work practices
- Proper use of PPE
- Policies for waste segregation and disposal
Orange Book and Generic Substitution is what?
State law permitting pharmacists to substitute GENERICALLY in some manner, state laws DIFFER
If substituting for a generic the label must what?
Accurately differentiate generic product from brand
If you label a generic as a brand is that misbranding?
YES
What is the role of the Orange Book?
Evaluates pharmaceutically equivalent products on the basis of bioequivalence
What is Pharmaceutical Equivalence?
Products contain same active ingredients and are identical in strength and dosage form
What type of rating system does the Orange Book use?
2 Letter aka A and B
What does A mean in the rating system?
A: considered therapeutically equivalent to reference drug products
What does B mean in the rating system?
B: NOT considered therapeutically equivalent for any number of reasons
What does AA Mean?
Available in conventional dosage forms and no bioequivalence problems
What does AB Mean?
Identifies by FDA as having actual or potential bioequivalence problems, but which have been resolved by adequate scientific evidence
Beyond AA and AB, what does the second letter denote?
Dosage Form
What does AN Mean?
Bioequivalent solutions/powders for aerosolization
If the first letter of rating is B what does that mean?
Take a second look
If there are multiple drugs that are not bioequivalent how is that rated?
3 letter, AB1, AB2, etc
What is a Biosimilar Product?
Biosimilarity means products are highly similar to the reference product with no clinically meaningful differences in safety, purity, and potency
What is the Purple Book?
FDA book noting biosimilars with B and interchangeable with I
What does Interchangeable in the purple book mean?
I = products can be substituted for a prescribed product as long as the prescriber did not specify
What does Biosimilar in the purple book mean?
B = not interchangeable, cannot be substituted
What is the Prescription Drug Marketing Act of 1987?
- Requires state licensing of wholesalers
- Bans reimportation of Rx drugs except by manufacturer
- Bans sales, trade, or purchase of Rx drug samples
- Mandates requirements for Rx drug samples
- Prohibits resale of Rx drug purchased by hospitals or healthcare facilities
What is the definition of a drug sample?
Unit of drug not intended to be sold and intended to promote the sale of the drug
Can pharmacies receive drug samples?
ONLY if it is request by the prescriber and receipt must include specific details
What is the Pedigree Requirement?
In 1999, the FDA wants to start a pedigree requirement to track irreparable harm to victims and violate equal protection clause
When is the Pedigree Requirement suppose to take place?
DSCSA of 2012 requires system to be in place by 2023
What is the Point Prevention Packaging Act PPPA?
Intent of act to protect children from accidental poisoning due to HOUSEHOLD substances
What does the PPPA act refer to for pharmacy?
Child resistant containers
