ABOUT COMPOUNDING PHARMACIES
What is a Compounding Pharmacy?
Medications are compounded when a formulation of a drug is needed but not commercially available at a retail pharmacy. Compounding pharmacies prepare customized dosage forms and/or prescription medications to meet an individual patient’s or physician’s needs. The pharmacy is responsible for the manufacturing of a medication by formulating a drug into a medicine based on the good compounding practice guidelines.
Compounding pharmacies prepare a prescribed medication and ship it directly to a patient’s home. Patients can get refills this way, too
Why Do Compounding Pharmacies Exist?
Compounding pharmacies perform a vital role in healthcare by meeting special patient care needs. Their role is to create custom drug mixtures for a single patient with a valid prescription.
Pharmaceutical compounding is synonymous to patient-centered services with an added value for the consumers. Today's advanced practice provides customized treatment options for unique patients or for hard-to-treat conditions.
These products fill a niche market for pain relief, dermatologic conditions and other disorders where no FDA approved product exits, i.e., the medication cannot be satisfied by commercially accessible pharmaceutical products in the area of pharmacy.
Pharmacists also compound a variety of topical and oral preparations. Reasons for compounding aim to fill the need for non-commercially available dosage forms, drug shortages or where the commercial product is simply not tolerated by an individual patient. Some patients are allergic to the non-essential filler and binder ingredients in mass-produced medications, e.g., gelatin, gluten, wheat, and peanut oil derivatives.
How are Compounding Pharmacies Regulated?
Individual state pharmacy boards, the U.S. Food and Drug Administration, and other professional organizations mandate standards and guidelines for the compounding of these medications.
The FDA designated 503A compounding pharmacies as those that compound according to prescriptions specific to particular patients and are required by state boards of pharmacy to comply with USP and other guidelines.
In 2013, Congress passed the Drug Quality and Security Act (DQSA) which made updates to the Federal Food, Drug and Cosmetic Act (FD&C Act) regarding human drug compounding. Within the DQSA, “Section 503A describes the conditions under which compounded human drug products are exempt from the FD&C Act sections on FDA approval prior to marketing, current good manufacturing practice (CGMP) requirements, and labeling with adequate directions for use. One of these conditions is that the drugs must be compounded based on the receipt of valid patient-specific prescriptions.” To read more about the 503A compounding laws and policies, please visit the FDA’s website.
Lee Silsby Compounding Pharmacy employs the finest clinically-trained specialists who tailor medication needs to individual patient needs. If you’d like to learn more about the quality training of our team members, please contact us at firstname.lastname@example.org.