Before 1950 there was no mass manufacturing of drugs so pharmacies had to know how to calculate pharmaceutical compounds. Pharmacies that are set up to mix the ingredients of prescription medications that are customized for a specific patient are called compounding pharmacies. Up until 1950, almost 60% of all medications were compounded. Presently only about one percent of medications are compounded.
In order to make pharmaceutical compounds, the pharmacist needs:
- To know how to calculate pharmaceutical compounds
- A sterile environment
- Compliance with FDA and state regulations
- The highest quality of ingredients
- Who can compound medications? Medications must be prescribed by a licensed medical doctor and must be prepared by a licensed pharmacist. It is specialized because regular pharmacies do not have the training, the specialized ingredients necessary, or the proper sterile environment to prepare the pharmaceutical compounds.
- What can be compounded? The ingredients that are going to be compounded must be either FDA approved or approved by the U.S. Pharmacopoeia National Formulary for compounding. If a drug has been taken off the market because it wasn’t safe or didn’t work, it cannot be compounded.
- Are compounded medications safe? Pharmacies that compound medications are regulated by the FDA. Product safety and consistency are regulated by the pharmacy boards of each state so there may be a difference in regulations. Always inquire about the standards when looking for a compounding pharmacy to make sure your medication will be safe.
- Reasons for compounding medications. The main reason for pharmaceutical compounds is so the patient and the doctor can determine what medications will be the most beneficial for the patient’s healthcare and be sure the medication is of the best quality. Other reasons for pharmaceutical compounds are: making a pill into a liquid for those having problems swallowing, special flavored medication for kids, or taking out an allergic ingredient in a medication that the person needs to take. Sometimes mass produced drugs don’t have the right dosage, so special medication has to be made. For patients that do not take their medications like they are supposed to, pharmaceutical compounds can be made into a time-release capsule so they don’t have to take so many pills. Also, a patient may need a medication that is discontinued because not enough people were taking it.; therefore, the medication has to be made as a pharmaceutical compound.
- What is the procedure for obtaining a pharmaceutical compound? The doctor writes the prescription and clearly marks it compound. It is then taken to a pharmacy that specializes in pharmaceutical compounds because not only do they need specialized training, they also need specialized ingredients which regular pharmacies do not have..
- What are the requirements that must be met by the pharmacist preparing the pharmaceutical compound? Since the pharmacist is responsible for the quality, purity, and strength of the prescription from the doctor, he must know how to calculate the pharmaceutical compound. He must also be aware of expiration dates and the proper labeling and packaging. He must make sure that the formula used and the ingredients in the compound stay consistent with each refill. The steps he must take in preparing a pharmaceutical compound are: preparing, compounding, checking calculations of the ingredients in the compound, signing off, and cleaning up.
- Other important guidelines compounding pharmacists must follow are:
- Keep up with current trends by reading literature, attending seminars, and communicating with colleagues
- Understand the guidelines regarding compounding
- Knowledge of all state rules and regulations and FDA requirements
- A thorough knowledge of chemicals and ingredients used in compounds including hazardous chemicals and emergency procedures in case of accidental exposure
- Provide a sterile area where compound is prepared
- Make sure personnel wear proper protective clothing so compound is not contaminated
Tip: When taking your prescription to a compounding pharmacy make sure they know how to calculate a pharmaceutical compound and have all the necessary quality ingredients and equipment to prepare your medication.