The US Food and Drug Administration (FDA) is finalizing without change a proposed regulation introduced last year which would establish an administrative detention process for pharmaceutical products it believes are adulterated or misbranded.
The rule is borne from the Food and Drug Administration Safety and Innovation Act (FDASIA), Section 709 ("Administrative Detention") of which ordered FDA to promulgate a final regulation within two years of the passage of the law regarding the detention of both drugs and devices.
In particular, the law adds "drugs" to the definition of Section 304(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act), which gives FDA the authority to detain "for a reasonable period which may not exceed 20 days" any product it believes to be misbranded or to have been manufactured outside of conformance with quality regulations (i.e. adulterated). An additional 10 days of detention may be authorized if additional time is needed to initiate enforcement actions, the statute adds.
The intent of the section is to permit FDA to take proactive action against questionable products, thereby allowing it to better protect the pharmaceutical supply chain. Without the authority, it would need to launch an investigation regarding the origins or status of a product, all the while the product would be free to proliferate around the country. As a result, by the time FDA obtained proof or permission to detain a product, consumers might already have been injured.
A similar rule proposed in 2014 would allow the agency to then destroy some of those drugs rather than permitting them to be re-exported.
Detention Proceedings and Appeals
The rule itself, Administrative Detention of Drugs Intended for Human or Animal Use, establishes exactly how FDA would go about detaining a product. Under Section 1.980(b) of the proposed rule, detention proceedings would begin when an authorized FDA representative conducting an inspection under Section 704 of the FD&C Act "has reason to believe that a drug … is adulterated or misbranded." As in the existing statute, this detention should not exceed 20 days unless an additional 10 are needed to bridge a gap through legal proceedings. Such an extension could only be authorized by a district director.
Under 1.980(d), detention orders must be issued in writing, signed by an authorized FDA representative, and issued to the owner, operator or agent in charge of the place where the pharmaceutical products are presently located. Copies of the detention order much be provided to the legal owner of the drug if the present owner of the drug cannot be determined. If the products are not in a facility, but are instead in a vehicle or mobile carrier, a copy of the notice must be given to the shipper of record and to the owner of the vehicle.
Under 1.980(b)(3), the order must contain a statement of the detention period, a statement regarding the reasons for detainment, the location of the drugs, a statement ordering that the drugs not be moved or tampered with, an identification of the detained drugs, the detention order, period of detention, and information regarding the process for appealing and contacting FDA.
All detention orders must also be approved by the local FDA district director in writing, though oral approval may be obtained in extraordinary circumstances so long as the order is confirmed in writing "As soon as possible."
Detained drugs will be affixed with a label that the drugs are detained by the US government, and that altering or tampering the drugs subjects an individual to fines, imprisonment or both.
Movement, Destruction and Release
Section 1.980(g) allows the owner of a detained drug product to appeal the detention order, which must be done within five working days of initial receipt of the order. Any hearing must be conducted within 5 working days after the appeal is filed.
Drugs are generally not to be moved, but several exceptions exist to this rule. For example, if the detained drugs are not in final form for shipment, they may be moved within an establishment (i.e. the manufacturing facility) to complete the work needed to put them in final form. FDA must be notified of this movement, and the drugs must be segregated from other product and not moved thereafter. In addition, FDA may issue written permission to move a detained drug product if the movement will serve to destroy the drug, preserve the drug, allow the facility to continue operating or bring the drug into compliance with regulations.
If FDA determines that the detained product is adulterated or misbranded, it "may initiate legal action against the drugs or the responsible individuals, or both, or request that the drugs be destroyed or otherwise brought into compliance with the FD&C Act under FDA's supervision," the rule states. Otherwise, as the end of the 20/30 day period, FDA will issue a "Detention Termination" notice releasing the drugs to the owner, who must retain all records of the detention for two years.
FDA says the rule will go into effect in 30 days after its publication in the Federal Register.
The only evident change: Whereas the proposed rule called for it to be placed at 21 CFR 1.501 (Subpart L), the final rule calls for it to be placed at 21 CFR 1.980 (Subpart Q), while reserving subparts L, M, N, O and P for future use. FDA said this is due to the issuance of "other regulations in Part 1, requiring reassignment of the section number within part 1."
Administrative Detention of Drugs Intended for Human or Animal Use