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IACP Approves New Labeling Guidelines

P2C2 Makeover - IACP Organizes Patient & Physician Advocacy Affiliate

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Frequently Asked Questions

What is pharmacy compounding?

Compounding pharmacy is the customized preparation of a medicine that is not otherwise commercially available.  These medications are prescribed by a physician, veterinarian, or other prescribing practitioner, and compounded by a state-licensed pharmacist.  A growing number of people and animals have unique health needs that off-the-shelf, one-size-fits-all prescription medicines cannot meet.  For them, customized medications are the only way to better health.

Why is pharmacy compounding important?

Compounded medications fill a void left by drug companies who produce medicines in strengths and forms that are not right for every patient, or sometimes discontinue medicines because they are not in high enough demand to be profitable medicines that many patients still rely on.  

Who needs compounded medications?

Many different kinds of patients rely on compounded medications to treat their conditions, including:

  • women suffering from hormone imbalance who take bioidentical hormone replacement therapy;
  • patients mostly children who need their medications specially flavored to make them easier to take;
  • patients who are unable to take medications orally and need compounded ointments or solutions;
  • patients taking multiple drugs who can take them more easily when compounded into a single dose, including hospice patients taking multiple pain management medications;
  • cancer patients whose chemotherapy treatments are precisely designed for their specific needs;
  • patients who are allergic to binding agents, preservatives and other ingredients in off-the-shelf medications;
  • non-food animals pets, show animals, zoo animals, etc. whose unique needs are unmet by manufactured pharmaceuticals.

Who regulates compounding?

Compounding is part of the long tradition of pharmacy and, as a result, is regulated by state boards of pharmacy.  The National Association of the Boards of Pharmacy and the United States Pharmacopeia the national standard setting organization for pharmacy and pharmaceutical manufacturers have established standards for compounding that are enforced by many states. The materials that make up the medications are all sourced from licensed FDA-registered manufacturers in many cases, the same sources used by pharmaceutical manufacturers. The Food and Drug Administration, the Supreme Court, Congress and virtually every major health professional organization recognizes the value of compounding.

Where are compounding pharmacists trained and licensed?

Compounding pharmacists are trained and licensed in pharmacy school.  States require that pharmacy schools must as part of their core curriculum instruct students on the compounding of pharmaceuticals.  Pharmacists are licensed to compound by their state board of pharmacy.

Are compounded medications safe?

Every precaution is taken to ensure that your drugs are safe.  State boards of pharmacy regulate pharmacy compounding and license trained pharmacists to practice compounding.  Many of these regulations stem from standards that are developed by the National Association of Boards of Pharmacy and the United States Pharmacopeia, the national standard setting organization for pharmacy and pharmaceutical manufacturers.  There are inherent risks when taking any prescription medication and we encourage every patient to consult with his or her doctor and pharmacist when considering prescription medication.

Do all pharmacies offer compounded medications?

Most pharmacies provide at least simple compounding.  However, some pharmacies specialize in compounding more complicated products especially those that require specialized equipment.

What is the difference between compounding and manufacturing?

By definition, compounded medicines are different than commercial pharmaceuticals; they are prepared at the direction of licensed physicians or veterinarians to meet patients’ individual needs that are not met by manufactured pharmaceuticals, which are mass produced in uniform strengths and dosage forms.

 

 

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