This information collection supports
implementation of Sections 503A and 503B of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) and includes reporting,
recordkeeping, and disclosures. Section 503B pertains to
outsourcing facilities and sets forth criteria under which sections
502(f)(1), 505, and 582 do not apply for a drug compounded by or
under the direct supervision of a licensed pharmacist in a
registered outsourcing facility. Section 503A pertains to human
drug compounding and sets forth criteria under which sections
501(a)(2)(b), 502(f)(1), and 505 of the FD&C Act do not apply
for a drug product compounded for an identified individual patient
based on the receipt of a valid prescription order approved by a
practitioner. Respondents to the collection are those who compound
drugs, outsourcing facilities, and State Boards of Pharmacy or
other State Agencies entering into a MOU with FDA to address
certain distributions of compounded human drug products.
The information collection is
being revised to include the collection of related data elements.
This results in an additional 8,970 annual responses and 7,789
additional hours of estimated burden to the information
collection.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
503A; Disclosure