The Food and Drug Administration (FDA) cautioned the public about unsafe drug products from unauthorized sources such as medical doctors, unlicensed clinics, and other health facilities.
In an announcement signed by Director General Samuel Zacate, the FDA reiterated its public warning against accessing drug products from unauthorized sources and reminded all concerned to follow the regulations set by regulatory agencies.
“Medical doctors, as part of their practice, utilize drug products,” the FDA said. “However, several doctors procure, store, and offer for sale drug products to their patients,” it added.
The FDA advised the public “not to avail of medicines from clinics of doctors” unless authorized.
The FDA noted that there are medical doctors, clinics, and health facilities that sell drug products “without proper authorization” issued by the agency.
Some offer products “without the supervision of a pharmacist” as well as those that do not issue receipts which is a violation of the existing trade and revenue regulations.
Moreover, the FDA warned against accessing drug products from these unauthorized sources because they might not observe “good distribution and storage practices, " violating the agency's standards.
The FDA explained that under Republic Act (R.A.) No. 10918, dispensing is defined as the “sum of processes performed by a pharmacist from reading, validating, and interpreting prescriptions; preparing; packaging; labeling; record keeping; dose calculations; and counseling or giving information, in relation to the sale or transfer of pharmaceutical products with or without a prescription or medication order.”
Given this, the FDA stressed that “dispensing is an exclusive activity of a pharmacist, to be conducted only within a licensed establishment.”
The FDA noted that following Republic Act No. 3720, as amended by R.A. No. 9711, the Department of Health (DOH) issued Administrative Order No. 2020-0017 requiring all establishments that sell or offer to sell drug products to first “secure appropriate License to Operate (LTO) or authorization from FDA prior to engaging in such activities.”
Meanwhile, the FDA also reiterated that all licensed drug manufacturers and distributors are “not authorized” to sell to unlicensed outlets, including clinics of medical doctors.
“All concerned are requested to immediately cease from conducting such activities until proper authorization has been secured,” the FDA said.
“Regulatory actions and sanctions shall be strictly implemented in case of non-compliance,” it added.