(C) Using the materials referred to in 
paragraph (3), the practitioner educates the pa-
tient on the drug, including providing one-on- 
one, in-person counseling. 
(D) The practitioner provides to the pa-
tient the questionnaire referred to in paragraph 
(3), and the patient completes the question-
naire. 
(E) The patient signs a statement pro-
viding the informed consent of the patient to 
undergo treatment with the drug (or a parent 
or guardian of the patient signs the statement, 
in the case of a patient who is a minor or other-
wise lacks legal capacity). 
(F) The patient undergoes the appropriate 
blood tests. 
(G) In the case of a female patient— 
(i) the education under subparagraph 
(C) includes education on the need to avoid 
becoming pregnant while being treated 
with the drug; and 
(ii) the practitioner determines that 
the patient is not pregnant, as indicated by 
an electronic verification, provided to the 
practitioner by an accredited laboratory,
that the patient has undergone a preg-
nancy test and received a negative result. 
(H) In the case of a male patient, the edu-
cation under subparagraph (C) includes edu-
cation on the need to avoid impregnating 
women while being treated with the drug. 
(I) The prescription is issued only after 
compliance with subparagraphs (B) through 
(H). 
(J) The prescription is for a 30-day supply 
of the drug, with no refills. 
(K) Each further prescription for the drug 
is issued by the practitioner to the patient only 
pursuant to another in-person consultation with 
the practitioner, and prior to issuing the pre-
scription, compliance with subparagraphs (C) 
through (I) is repeated. 
(L) The patient undergoes the appropriate 
blood tests 30 days after the conclusion of 
treatment with the drug. 
(5) Such additional conditions as the Secretary 
may by regulation determine to be necessary to pro-
tect the public health with respect to the drug. 
(c) CERTIFICATION OF TREATMENT CENTERS.—For 
purposes of subsection (b)(2), the conditions for the pro-
gram to certify a clinic or medical office as a treatment 
center regarding a drug containing isotretinoin are as fol-
lows: 
(1) The program determines that each of the 
practitioners at the clinic or office who will prescribe 
the drug is in compliance with the following: 
(A) The practitioner is authorized under 
the law of the State involved to administer pre-
scription drugs. 
(B) The practitioner has registered with 
the program and received education on the po-
tential side effects referred to in subsection 
(b)(1)(B). 
(C) The practitioner agrees as follows: 
(i) The practitioner will prescribe the 
drug for a patient in accordance with sub-
section (b)(4). 
(ii) If a female patient being treated 
with the drug becomes pregnant, the prac-
titioner will immediately report the preg-
nancy to the program and provide follow- 
up in accordance with the program. 
(iii) The practitioner will not issue 
prescriptions for the drug by telephone or
facsimile transmission, or through the 
Internet. 
(iv) The practitioner will— 
(I) report to the Secretary any 
information received by the practi-
tioner on adverse events that are asso-
ciated with the use of the drug by pa-
tients of the practitioner; and 
(II) submit such reports quar-
terly, except in the case of a patient 
death associated with the drug, in 
which case the report will be sub-
mitted immediately, but in no case 
later than 15 days after the date on 
which the practitioner learns of the 
death. 
(D) The practitioner has signed and filed 
with the program a statement that the practi-
tioner understands the conditions for participa-
tion in the program as a practitioner, and will 
maintain compliance with the agreements de-
scribed in subparagraph (C) and otherwise com-
ply with applicable conditions. 
(2) After the initial certification of the clinic or 
office, the program renews a certification for addi-