Pharmacy Law Lecture 4

Compounding Quality Act 503A Provisions

-Removed unconstitutional bans on advertising compounded drugs that were in FDCA ex. advertising of hormonal replacement therapies -This act also stated that if you are a compounding pharmacy then you don't have to follow CGMP or have adequate directions for use, and you dont have to submit a "new drug application" under the New Drug provisions of FDCA if the Rx is: 1. Compounded for individual patient 2. Based on valid prescription 3. Compounded by licensed pharmacist/physician cGMP= current good manuf. practices

What can NOT be compounded under 503A

1. Drugs or components of drugs that are on an HHS Secretary list of drug products/components withdrawn or removed due to SAFETY OR EFFICACY reasons. 2. Essentially a COPY of commercially available drug. 3. Drugs with "DEMONSTRABLE DIFFICULTIES TO COMPOUND" (HHS to publish list)...basically too difficult to compound HHS= Health and Human Services ON EXAMMMMM IF IN CAPS

Does 503A or 503B require CoA (certificate of analysis) to prove that what they claim the drug is...is actually that drug.

503B

What is Section 503B of the Compounding Quality Act (not 503A...be careful!)

503B deals with Outsourcing Facilities -this focuses on compounding STERILE products

Describe what can not be compounded under 503B

503B facilities may not compound: - Drugs withdrawn for SAFETY/EFFICACY reasons - Essentially COPIES of commercially available drugs - Drugs with DEMONSTRABLE DIFFICULTIES in cmpd'ing. - Drugs subject to REMS (unless prior approval) - If the receiving entity will sell at WHOLESALE (the wholesaler cant be selling the medication they compound...hence why 503B meds are usually sent to hospitals and PCP offices to be GIVEN to pts) KNOW FOR EXAM(STUFF IN CAPS)

Describe what anticipatory compounding means

Anticipatory compounding ok if - Limited quantities - Based on history of receiving Rx for the med ex. a doctor that always sends rx to your pharmacy always prescribes progesterone suppositories. since you know he prescribes around 5 that need to be made every week, you can anticipate that it will occur every week. therefore you can make those 5 suppositories. ahead of time to be ready for the week

TRUE or FALSE: A 503B facility can compound non-sterile preparations so long as they are compounded in accordance with USP 795?

FALSE -any NON-sterile medication that is compounded needs to be made in compliance with cGMP (current good manuf. practices) in class she dont worry as much about this....remember that 503A is non-sterile preps and 503B is sterile

TRUE or FALSE If a pharmacy compounds in the regular course of business it is considered a manufacturer

FALSE -they are not considered a manuf. -think about this as Wags making magic mouthwash

What is 503B- Outsourcing Facilities

Facility, at one geographic location, that: 1. Compounds STERILE products. 2. Elects to VOLUNTARILY register with FDA. 3. Complies with ALL sections of FDCA §503B 4. FDA inspections 5. May or may not obtain Rxs for specific patients ...but all of their products tend to get shipped to hospitals or PCP offices 6. May or may not be a pharmacy...either way it needs to be completely separate from everything else 7. Has RPh who directly supervises drug compounding

TRUE or FALSE: If a patient requests that a pharmacist repackage a 500-count container of OTC ibuprofen 200mg tablets into five individual containers with six tablets each, for vacation travel, the RPh should decline.

TRUE -RPh cannot repackage any OTC products without being registered under the FDA as a "repackager"

TRUE or FALSE: A pharmacy can legally compound a preparation consisting of 20 mg tablets of atorvastatin if it is validly prescribed to a patient with the allergy and the preparation omits the allergenic ingredient?

TRUE -its made for an individual patient so its okay

TRUE or FALSE: pharmacies that repackage OTC products or in any way change the container, wrapper, or labeling for resale must register with FDA as Manufacturers/repackagers

TRUE -its not being sold in its original OTC product, so they need to have the credentials to repackage those medications

Which one is 503A and which one is 503B

Traditional compounding pharmacies (503A) Non-traditional Outsourcing Facilities (503B)....deal with sterile compounding

Do 503B facilities need to register with/under the FDA

YES they MUST register with FDA If no FDA registration, then will be treated like a manufacturer: NDAs required for compounded drugs, additional labeling requirements under FDCA, etc ----------- they must: 1. tell FDA what sterile compounding is intended, drugs facility recently compounded, et al 2. allow FDA risk-based inspections 3. submit adverse event reports to FDA

When are pharmacies exempt from manufacturer's registration requirement

if they "do not manufacture, compound, or process drugs or devices for sale other than in the regular course of business . . .

What are 3 things that drug manufacturers must do

• Register with FDA • List drugs with FDA • Comply with cGMP regulations