Compounding, in a pharmaceutical sense, is the preparation of personalized medications. This allows a patient to get a strength and dosage (and possibly even flavor) to match an exact need. A prescriber, such as a doctor or veterinarian, may work with a pharmacist to create a specialized medication in a form that the patient can take, free of any ingredients to which the patient may have an allergy or sensitivity. This could include a size or shape that a puppy can swallow, or an emulsion of a very small dose for a child. Instead of a cat eating right around a pill hidden in food, compounding can provide needed medication in the form of a fish flavored liquid. Instead of a pain reliever that is difficult for a hospice patient to swallow, compounding can create a topical gel or cream that can be applied directly to a pain site and absorbed by the skin.
Once upon a time, all medications were compounded. In the 1950s, mass production of drugs rose and compounding fell. In recent years, however, more pharmacists are filling the needs of special populations with more unique requirements that commercially-available drugs to not meet.
Compounded medications do not go through the FDA approval process required for mass-produced drugs. But the active pharmaceutical ingredients are regulated, as is the pharmacy itself. If a pharmacy compounds in an unsafe or unsanitary manner, the patient’s health can be adversely affected.
The Board of Pharmacy has been operating under emergency regulations regarding the standards for compounding and beyond use dates (BUDs) of compounded drugs since December 19, 2017, and has started a regular rulemaking with a 45-day public comment period from August 3, 2018 through September 17, 2018. The Board proposes to make changes affecting Title 16, California Code of Regulations, Sections 1735.1, 1735.2, 1735.6, 1751.1, and 1751.4.
At Simas & Associates, our attorneys are very familiar with the rulemaking process, and the steps by which a person can make their views known. If you need assistance with navigating the regulatory system, please contact us.
To read about the Board of Pharmacy’s proposed regulations and their process, go to https://www.pharmacy.ca.gov/laws_regs/pending_regs.shtml.