Compounding

What is compounding?

Manipulation of a drug, other than in accordance with the FDA approved label, to make a different formulation of the drug to meet the needs of a specific patient

What aspects of the drug can be affected by compounding?

Absorption and depletion

What can happen to drug concentrations with compounding?

Can end up above or below the therapeutic range

Why can compounding lead to adverse drug events, including therapeutic failure?

Drug concentrations can end up outside of the therapeutic range

What is not included in compounding?

Mixing, reconstituting, or other such actions that are performed in accordance with directions on an approved label

When can compounding be done?

Within confines of a legitimate veterinary practice

Within confines of a valid vet-client-patient relationship

What should compounding be?

The exception to the rule -> not routinely used

Are compounded products considered similar to FDA approved products?

NO

Should compounded products by used routinely?

NO

In some states, compounded drugs are not allowed to be what?

Re-dispensed to clients, have to be administered or prescribed

In some states, where is the only place compounded drugs can be dispensed?

By the pharmacy/practice that compounded them

What should the client be told about compounded drugs?

It has not been evaluated by the FDA for potency, stability, efficacy, or safety

Are compounded drugs equivalent to generic drugs?

NO

Where should adverse compounded drug events be reported?

FDA CVM (same for any drug)

What are the regulations around non-sterile compounded drugs in Kansas?

Shall not compound bulk chemicals for food-producing animals

Packaged with a label that says "For Office Use Only - Not for Resale"

Any pharmacy may distribute without a prescription, including providing limited quantities to a practitioner in the course of professional practice to administer (can give for use in clinic, not for resale)

What are the reasons to use a compounded product?

Strength/size is inappropriate

Formulation is not available

No available manufactured product

When should a compounded product NOT be used?

Similar FDA product is available

A substitute FDA approved product is feasible

Ease of use when other formulations have not been tried

Cost

What are reasons for compounded product treatment failure?

True ineffectiveness of the drug

Formulation error

Poor stability

What can cause adverse effects from compounded products?

Drug itself

Formulation errors

What veterinary specific regulation allows compounding from bulk or active pharmaceutical ingredients?

Guidance for industry 256

What is guidance for industry 256?

Allows veterinarians to compound products from bulk or active pharmaceutical ingredients

Is compounding from bulk or API illegal?

Yes, but FDA chooses not to enforce it

Some exceptions do exist

Who sets the standards for compounding from bulk or API?

United States Pharmacopeia (international organization)

What is the main rule around compounding from bulk or API?

It must not be a copy of an FDA drug; there must be a specific difference

When is it appropriate to compound from bulk or API?

Lack of availability

Approved product has inapproriate concentration or size, or the animal is allergic to the flavoring

When is it not considered appropriate to compound from bulk or API?

Cost

Minor changes in concentration/size

Does the 503 A Compounding regulation apply to veterinary patients?

No, only for human patients

Does the Guidance for Industry 256 regulation apply to veterinary patients?

Yes, it is the main compounding regulation

Is a 503B Outsourcing facility registration important for veterinarians?

No, it's human specific. Doesn't gaurantee much

What is the appropriate way to compound?

Make it patient-specific

Start with FDA approved tablets

What are the major differences between brand/generic drugs and compounded drugs?

Brand/generic - FDA approved, inspected for safety, efficacy, good manufacturing practices, and manufacturing processes. Bioequivalence is known (generic drugs)

Compounded - no FDA approval, no safety or efficacy, not subject to good manufacturing practices

What does a certificate of analysis mean?

Powder was tested one time

Does NOT mean that tablet/capsule made was tested

What does a certificate of analysis not account for?

Incorrect amounts added to the formulation

Lack of repeatability

Lack of stability

What is the passing range for a drug's stated content to be considered acceptable?

90-110% of stated content