Lec 3: Compounding Law & Ethics Flashcards
Compounding and manufacturing are two distinct terms:
Manufacturing
Production, preparation, propagation, conversion,
processing, packaging, repackaging, or labeling of a prescription drug. Commercially available products
from bulk for resale by pharmacies, practitioners, or other persons…Must follow Current Good Manufacturing Practice (CGMP) regulations
Compounding and manufacturing are two distinct terms:
Compounding
- Compounding- “combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient”
- Pharmacist-patient-prescriber relationship (“triad”)
- Pursuant to a valid prescription
- Prior to receiving RX on the basis of history
- Do not require FDA approval
- Do not need to adhere to CGMP requirements
Compounding or not? : A pharmacist prepares compounded progesterone 200mg capsules that do
not contain peanut oil, pursuant to a prescriber’s prescription for a patient who is severely allergic to peanuts. Assuming that the pharmacist adheres to all other legal & regulatory requirements for preparing a compounded medication, does this meet the legal definition of compounding?
Yes! This is compounding because patient has a peanut allergy so you’re making this patient specific and there is also a triad relationship
.
They have an allergy to peanut oil so they cannot take the commercially available progesterone that have peanut oil in there. So we are making something that is individualized to this patient = compounding. There is also that triad: patient went to doctor, doctor wrote the rx, patient brings it into pharmacy! So you are allowed to compound this!
Compounding or not?: A pharmacist prepares memantine 5mg tablets based on a recipe from
Forest Laboratories, the manufacturer of Namenda, and sells them as a compounded product. The compound does not differ from Forest Laboratories’ recipe. The compound is prepared pursuant to a prescriber’s
prescription for a patient. Assuming that the pharmacist adheres to all other legal & regulatory requirements for preparing a compounded medication, does this meet the legal definition of compounding?
No - this does NOT meet the legal definition of compounding…b/c this is a copy of a commercially available product and if you look at regulations… we cant just copy a commercially available product… this can be messed up/ the drug can be messed up! We CANNOT copy a commercially available product! it is sus!
A prescriber regularly writes prescriptions for a Magic Mouthwash which contains one part each of diphenhydramine, nystatin, viscous lidocaine, and Maalox. The prescriber writes about 100 prescriptions per week for this product, and her patients often come to your pharmacy since you are right across the street from the prescriber’s office. You have a Master Formulation Record for “Dr. Singh’s Magic Mouthwash” and decide to prepare 20 bottles of Magic Mouthwash ahead of time, since you receive so many of these prescriptions. Assuming that you adhere to all other legal & regulatory requirements for preparing a compounded medication, does this meet the legal definition of compounding?
Select one:
a. Yes
b. No
Yes! This does meet the legal definition of compounding/ it is legal! :)
Why: We are doing this based off of the history that we have received many of the prescriptions before! WE can’t just decide that we want to make these but we KNOW that we get these rx on a regular basis so it’s ok to prep…20 bottles is ok…5000? no… a month supply is good enough! The amount needs to be reasonable.. making too much is sus.
The FDA’s compounding program
Federal Food, Drug, and Cosmetic Act
.
-Section 503A – “traditional” compounding by pharmacist or physician (eg. mortar and pestle compounding)
-Section 503B – outsourcing facilities (if you are a v large compounding facility that make stuff and distribute to other facilities! you can apply for the 503B)
.
They act as a middle ground between manufacturing and compounding!
Outsourcing facilities
NOTE: 503B came about after the meningitis outbreak! During this, a compounding pharm were making injections under poor condition that was contaminated and making large amount and shipping them across Stateline/ distributing to other facility! in part of respond to that The DQSA updated part of the FDA compounding guidelines to say that if you wanna make huge amount of product.. ok go for it but you must register as 503B! this allow compounding pharmacy to distribute to other facility and follow good manufacturing rule = stricter quality control and must allow FDA to come in! and if you have AEs you MUST report that to FDA!
USP is a non-profit organization that sets standards for a variety of topics… what are the 4 different USP
USP 795 – non-sterile compounding
USP 797 – sterile compounding
USP 800 – hazardous substances
USP 825 – radiopharmaceuticals
USP chapter above 1000? below 999?
Chapters below <1000> are legally enforceable
Above <999> are “guidance”
…
USP creates but does not enforce standards
Standards enforced by FDA. Compliance required by NM state regulations; enforced by BOP
Updates to USP chapters will become official in 2023
- USP 797 updates – November 1, 2023
- USP 795 updates - November 1, 2023 (mostly changes to BUDs)
- USP 800 – as of December 1, 2019 – “informational only” – 6 month grace period after updates to USP 797
- USP 825 – as of December 1, 2020 – “informational only”
In New Mexico, _______________ may enforce USP
standards
In New Mexico, the Board of Pharmacy may enforce USP
standards
The FDA relaxed some compounding requirements during COVID-related drug shortages
- Medications on the FDA’s drug shortage list are considered “not commercially available”
. - FDA will not take action against facilities that compound drugs that are “essentially a copy” of approved drugs that are discontinued
. - FDA released guidance on compounding medications in shortage such as amoxicillin pediatric suspensions – not to be done “regularly” or “in inordinate amounts”
. - Recommendation that hospital systems contact 503B facilities first for compounding needs
The _____________________ provides a Code of Ethics
The Alliance for Pharmacy Compounding provides a
Code of Ethics
Ethical Compounding general… (debatable topic so it won’t really be on exam!) . . .Hot Topics in Compounding Ethics?
“There’s an old saying: ‘You can’t talk your way out of a problem you behaved your way into.’ But professionally, it’s worse than that. As a pharmacy compounder, you
can’t talk your way out of a reputation that the worst actors in your profession have behaved their way into. Like it or not, how you’re perceived depends, in part, on your competitors’ behavior. Every negative compounding story in the news is a story about you.”
.
1) Dilution of chemotherapy drugs
2) Compounding less-expensive alternatives
3) Distilleries compounding hand sanitizer during COVID
4) Compounding & pain cream fraud
5) ‘Copies’ of compounding kits
6) Compounding of drugs used in lethal injections
What is the general purpose of USP 795?
Select one:
a. To provide compounders with guidance on applying good compounding practices for the preparation of non-sterile compounding formulations
b. To describe the conditions that will prevent harm or death to patients who receive compounded parenteral products
c. To serve as a guideline for punitive actions against pharmacists or who pharmacy personnel who violate compounding standards
d. To provide standards for the handling of hazardous materials in healthcare settings
a. To provide compounders with guidance on applying good compounding practices for the preparation of non-sterile compounding formulations
