The market for ophthalmic compounding pharmacies is projected to grow substantially. This growth is expected to be driven by rising incidences of chronic diseases, increasing adoption of sterile compounded medicines, and high product usage in ophthalmic routes of administration. These pharmacies specialize in manufacturing prescription medicines prescribed by healthcare specialists and patients for various purposes. The market is segmented by therapeutic area, product type, application, and compounding type.
To differentiate between commercial and ophthalmic compounding pharmacies, pharmacists should evaluate all the documentation provided by the manufacturer. This documentation should indicate whether the products are suitable for use in ophthalmology. Moreover, the pharmacist should establish a procedure for compounding. This procedure should include appropriate steps in compounding, including sterilization. In addition, pharmacists should also ensure that they follow USP guidelines when manufacturing ophthalmic products.
The FDA has recently increased its warning letters for ophthalmic compounding pharmacies. These letters result from joint inspections and licensing reviews. Moreover, improperly compounded products are a liability risk for ophthalmologists, and a plaintiff’s attorney will determine whether the product was prescribed according to FDA regulations. The plaintiff’s attorney will also analyze whether the pharmacist disclosed the risks of the compounded medication to the patient.
The ophthalmic compounding pharmacies can also alter the formulation of the medication. For instance, a patient with an allergy to a dye present in the medicine may require a half-dose. An individual suffering from psoriasis may require twice the strength of an antibiotic. A compounding pharmacist can purchase raw materials and custom-mix the medication to suit the patient’s needs. Once the ophthalmic compounding pharmacies have approved the medication, it can be customized to meet the patient’s exact needs.
As with any other business, ophthalmic compounding pharmacies are routinely reviewed. Be wary of a pharmacy with major deficiencies. Request multiple client references and copies of the most recent accreditation reviews. Accrediting organizations such as the Pharmacy Compounding Accreditation Board (PCAB) review members every three years. Moreover, request the pharmacist to provide you with their third-party testing records for every lot of medication. Aside from this, be sure to ask for the pharmacist’s references.
According to Coherent Market Insights, U.S. ophthalmic compounding pharmacies market is estimated to be valued at US$ 219.2 million in 2021 and is expected to exhibit a CAGR of 5.0% during the forecast period (2021-2028).
Compounded medications are a unique type of medication. The ophthalmic compounding pharmacies and technicians must utilize aseptic techniques to prepare medications. A clean room, micron filter, or autoclave is necessary for the preparation of the medications. In addition, the sterilized room must be monitored for endotoxins and bacteria. The ophthalmic compounding pharmacies should use USP and FDA-inspected raw materials. It is important to check the quality of raw materials since not all pharmacies strictly follow USP guidelines. Using non-USP grade materials can lead to potential problems with potency and purity. Also, they may not be able to provide as accurate output as a USP-graded product. These compounds may not be sterile and may be unsafe to use.
Ophthalmic compounding pharmacies can supply ophthalmic steroids and antibiotics, and ophthalmic-grade compounds, like mucosal fluid, to physicians. Many physicians are familiar with the compounding pharmacy’s extensive experience with sterile compounding. They should meet the management team of the provider and tour the facility. They should look at their SOPs, training, and validation procedures. They should also review recent regulatory inspection results.
